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CFS/ME & FMS & OI
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Trials & Surveys

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This is our page on clinical trials for chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivities, Gulf War illness, and related disorders. Studies can center around a treatment for improving overall functioning or a specific symptom, attitudes about illness by sufferers or towards them, coping mechanisms, general data gathering and research, or other things. The first section deals with factors to consider in deciding whether a clinical trial is right for you. The next section contains links for US national listings of trials and studies, including several specific to these disorders. 

Finally, a special section has selected current clinical trials in our home region of Washington DC, Northern Virginia, and Suburban Maryland, as well as other selected national and international clinical trials. We especially like to include those that can be done by mail or web questionnaire since more accessible (no travel, expense). Inclusion of a clinical trial in our listings is for informational purposes only and should not be read as a recommendation that you should participate in that trial or that we agree with a study's premise. In considering whether a particular clinical trial is right for you, please talk with the contact person for that trial, consult with your health care provider, and be sure to read the materials listed under the "Factors to Consider" section of this page.


Factors to Consider In Deciding Whether to Participate in a Clinical Trial


Links to US National Listings of Clinical Trials


Selected Current Clinical Trials

  1. Washington, DC Metro Region aka The US Capital, Northern VA, & some Maryland
  2. USA beyond the Capital Area - National - Includes Questionnaire Studies
  3. International - Includes Questionnaire or Survey Studies


Selected Capital Area CFS/ ME & FMS & OI Studies 

Let us know if you have information about a current clinical trial relating to CFS, FMS, or overlapping disorders in the Washington DC, VA, MD metropolitan area.

1 (DC Area) James Baraniuk, MD, at Georgetown receives NIH funding for CFS Research
2 (DC Area) Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With FM
3 (DC Area) Functional Magnetic Resonance Imaging as a Surrogate Measure of Fibromyalgia Symptoms
4) (DCArea) Joint Hypermobility Syndrome and FMS - Our May 2010 Meeting, by appt
4) (DCArea) Range of Motion and Neuromuscular Strain Issues in CFS (2012-2013)




1) (DC Area) Dr. Baraniuk at Georgetown receives NIH funding for CFS Research

October 2006, Receiving NIH Funding:

James Baraniuk, M.D., Georgetown University, Washington D.C., has found that despite its diverse clinical syndromes, the CFS proteome (the entire group of proteins in an organism or system) is the same, suggesting a strong relationship with malfunctioning of the central nervous system. Dr. Baraniuk developed the first predictive model of CFS based solely on objective data and he now proposes to recruit a new group of CFS and Healthy Control subjects to determine if the proteins in their cerebrospinal fluid will be a predictive marker of the spectrum of CFS symptoms. There is a high probability that these methods and markers will be of diagnostic value and will be useful for assessing changes over time in disease severity and treatment effects.

James Baraniuk, MD
(202) 444-8243
3800 Reservoir Rd, Gl008, Washington DC 20007-2113
Study ad, added 9/6/07.  Dr Baraniuk visited group 9/15/07. Still recruiting 3/2008....


Do you or someone you love have Chronic Fatigue Syndrome (CFS)?
 
We have performed lumbar punctures (“spinal taps”) on CFS, fibromyalgia (FM), and Persian Gulf War Illness (PGI) subjects and a group of healthy volunteers. The CFS and related groups had a unique set of proteins in the fluid surrounding their brains. This is very exciting because it is strong evidence that CFS, FM and PGI are “real” diseases. The proteins we found may turn out to be diagnostic markers for these syndromes, and become part of a test for CFS/FM/PGI illnesses. They also offer insights into the molecular mechanisms that go awry, and point towards potential treatments. First, however, we must perform more spinal taps on women with CFS and healthy control women.
 
We offer a new, paid, clinical research study with a 1 night stay at Georgetown University Medical Center, lumbar puncture and other, more simple tests. We are recruiting 50 women with CFS and 50 healthy women who want to help find a cure. Contact us at 202-687-8231 or by e-mail at cfsresearch@georgetown.edu .
 
Healthy women are also invited to participate by having lumbar punctures. Healthy volunteers are essential to be able to identify new, significant diagnostic markers that can distinguish between chronic fatigue syndrome and a normal state of health. These differences will point towards the cause(s) of chronic fatigue syndrome and potential new ideas about treatment and diagnosis.
 
All lumbar punctures will be performed in the Interventional Neuroradiology suite by skilled doctors and their staff. This special step is being taken to make sure that the procedure is performed in the safest possible fashion, and with the lowest possible number headaches or other complications.




2) Lifestyle Physical Activity to Reduce Pain and Fatigue in Adults With Fibromyalgia

(Opened 9/29/06 -- still recruiting 08/09)
http://www.clinicaltrials.gov/ct2/show/NCT00383084

Johns Hopkins University
Ages Eligible for Study:      18 Years to 65 Years
Genders Eligible for Study:      Both
Accepts Healthy Volunteers:      No

Inclusion Criteria:

Meets American College of Rheumatology (ACR) criteria for FM
Inactive at study entry
Willing to become more physically active
Understands and willing to follow study recommendations regarding lifestyle modification
Able to participate in the study for 2 years
Agrees to not make any changes to current FM-related treatments

Contact: Kevin Fontaine, PhD    410-550-2517    kfontai1@jhmi.edu


3) (DC Area) Functional Magnetic Resonance Imaging as a Surrogate Measure of Fibromyalgia Symptoms

(Opened 2009---   )

Do you have Fibromyalgia? Do you ache all over?
Do your muscles twitch tingle or burn for no reason?
Do you have widespread muscle pain and fatigue that limit how much you can do in a day?
Do you have areas around your neck and shoulders that are tender to the touch?
Do you have muscle stiffness and pain that seems worse in the morning?
Do you have trouble falling asleep and staying asleep?
Have you missed activities with family or friends because you were too tired or in pain?

Millions of Americans, like you, experience real pain and real fatigue that affect every part of your life.

WHAT IS THE PURPOSE?

All of the above may be symptoms of Fibromyalgia. Volunteers are needed for a research study evaluating the Role of MRI and Physical Therapy in evaluation and management of Fibromyalgia.

We hope to use the fMRI techniques to be able to determine if a person has fibromyalgia, to determine if future therapies work, and to better understand the cause of the illness itself.

Inclusion Criteria:

Have a moderate-to-severe level of daily pain.
Be age 18-65, female
Not be taking any opioid analgesics or other strong painkillers.
Willing to come off medications for fibromyalgia
Willing to undergo MRI scans
Willingness to use contraception during the study duration
Other criteria apply

Exclusion Criteria:

- Severe concomitant psychiatric illness, suicide risk, or substance abuse as determined by the MINI or investigator judgment
- Significant claustrophobia that will interfere with fMRI or PET scanning
- Self-reported inability to adhere to the study exercise protocol
- Severe medical health problems that will interfere with successful participation.
- Systemic autoimmune disease, such as systemic lupus erythematosus and rheumatoid arthritis. Stable organ specific autoimmune disease, such as Graves’ disease and myasthenia gravis will be allowed.
- Active malignancy. Basal cell carcinoma will be allowed.
- Pregnant or breastfeeding.

If you qualify for this study, you will receive all study-related examinations, lab work and physical therapy at no cost and may receive compensation for your time and travel.

You may stop being in this study at any time without any penalty or losing any benefits you would have normally received. You may or may not benefit from taking part in the study, but knowledge may be gained from your participation that may help others.


For more information please call

Brian Walitt, MD, Rheumatologist
MedStar Research Institute
(202) 877-8535
Brian.T.Walitt@Medstar.net
Study Flyer 1
http://cfsnova.com/trials/WalittFlyer1Oct09fMRI.PDF

Study Flyer 2
http://cfsnova.com/trials/WalittFlyer2Oct09fMRI.PDF

Study Approval Notice and Informed Consent Notice 
http://cfsnova.com/trials/WalittApprovalfMRI.PDF
(Includes a section of who would be eliminated from participating, many more details.)

PDF copy of Letter from Dr. Walitt to CFSupport
http://cfsnova.com/trials/WalittLetter.PDF



4) (DCArea) Joint Hypermobility Syndrome and FMS - by appt

  Research meeting on FMS & Joint Hypermobility - added May 3, 2010

  NOVA CFSupport Meeting
  Sully Governmental Center, James McDonnell Room
  (same building as Sully District Police Station)
  4900 Stonecroft Blvd, Chantilly VA 20151. Free.
  No registration required. (703) 968-9818, (410) 647-7578.
  See also: Meetings
 
 
Catie D. is a junior at a college in VA. She is majoring in Exercise and Health Sciences and doing research over the summer of 2010 for her degree.

Her research project will look at those with varying degrees of fibromyalgia (FMS) and testing them for joint hypermobility syndrome (JHS) to see if there is any correlation between FMS and JHS. 

She and licensed physical therapist, Secili DeStefano, will be administering questionnaires (includes medical history, the Fibromyalgia Impact Questionnaire (FIQ), and a Symptoms Intensity (SI)) to measure pain levels and functionality. They will also administer the Beighton/Brighton Score that will measure the amount of hypermobility in each participant.  The Beighton score is administered by asking the patient to perform simple movements (ex. extending their arm to show if there is any hyperextension).

Participants between ages 20 and 60 who are believed to have FMS who have signs/symptoms of FMS are needed.

In addition to a consent form for general participation, permission must also be given for PHOTOGRAPHS to be taken, though no photographs of faces will be included.

Excluded from participation are those who have had wrist surgery/carpals tunnel syndrome, pregnant/postpartum women, and those with lower back surgery/fusion of the vertebrae in the lumbar region. 

Please contact the researchers for further information:

Catie D

Secili DeStefano, PT, DPT, OCS   703-406-0296
Northern District Chair
Virginia Physical Therapy Association
and
45945 Center Oak Plz Suite 150
Sterling, VA  20166


5) (DCArea) (Range of Motion and) Neuromuscular Strain Issues in CFS (2012-2013)


Peter C. Rowe, M.D., is professor of pediatrics at Johns Hopkins Children's Center where he directs the Chronic Fatigue Clinic. Kevin R. Fontaine, Ph.D., is a professor at University of Alabama at Birmingham; and Richard L. Violand, Jr., is a physical therapist in private practice at Violand and McNerney Physical Therapists, in Ellicott, MD. Dr. Rowe's research project,"Neuromuscular Strain in CFS," is being funded by the CFIDS Association of America under its Research Institute Without Walls. Dr. Rowe was part of a Johns Hopkins team that was the first to identify orthostatic intolerance as a key feature of CFS. He has cared for CFS patients in his medical practice and conducted research on CFS for nearly 20 years.

From Dr. Rowe:
We are conducting a study that examines ways in which the nervous system might get sensitized in those with Chronic Fatigue Syndrome (CFS). The study involves a single visit to the Johns Hopkins Bayview campus for a half day. We do a follow-up phone call about symptoms the next day. We have recruited half of the study sample thus far, and can report that the study procedures have been well tolerated.

The study requires people to complete some questionnaires about baseline symptoms (about 45 min), have measurements of range of motion of the limbs, pain threshold measurements, as well as a Holter monitor to look at heart rate variability.

The study is funded by the CFIDS Association, and randomizes people to a neuromuscular strain for 15 minutes (we hold their leg elevated at a point where they feel stretch but not pain) or a more modest leg strain. Individuals can remain on their usual medications, but we want them to skip short-acting morning medications like midodrine, atenolol, stimulants, etc., on the day of the test. We are mainly looking for those with CFS between the ages of 16-50 years, but they need to at least moderate symptoms consistent with CFS. People with both CFS and FM are eligible, but they have to meet the CFS criteria.

Anyone who is interested in finding out more can e-mail Malini Moni, the research assistant who is coordinating things. Her e-mail is mmoni2@jhmi.edu.



Selected National CFS/ME, FMS, POTS/OI, & similar Trials

Section Contents, click for details.

1) Pregnancy in Fibromyalgia Questionnaire Study
   
Temple University in Philadelphia, PA. Long distance participants welcome.

2) CFS/ME in Children -  Questionnaire
     DePaul University, IL. Long distance participants welcome.

3) Psychosocial Treatment Trial for Multi-Symptom Illness, FM, CFS, IBS, TMJ, MCS
     Robert Wood Johnson Medical School, central NJ.

4) Insomnia Medication Trial or FM Patients
     Robert Wood Johnson Medical School, central NJ.

5) Study of Ampligen in Chronic Fatigue Syndrome: Recruiting Once Again
    Incline Village, NV; Salt Lake City, UT; Charlotte, NC.

6) A Study of Genetic Risk Factors That May Be Associated
      with Chronic Fatigue Syndrome (CFS)

       University of Illinois at Chicago and Tufts University    Added May 23, '08
        Long distance participants welcome.

7) Chronic Fatigue Study Questionnaire Study
       University of Utah                                                           Added Oct 2, '08
       Long distance participants welcome.

8) Vulvodynia - Cost of Illness Survey 
       National Vulvodynia Association                                    Added Oct 2, '08
       Long distance participants welcome.

9)  Fibromyalgia with Sleep Disturbances - medication trial
       Raleigh, NC                                                                    Added Aug 20, '09


10)  Fibromyalgia, Juvenile - Clinical Trial Testing the Safety and Efficacy of Fluoxetine 
       Cincinnati, OH                                                                  Added Aug 20, '09
       Long distance participants welcome.

11)  Coping Skills Training for Adolescents With Fibromyalgia
       Kentucky and OH                                                                  Added Aug 20, '09
       Long distance participants welcome.

12) Autonomic Nervous System and Chronic Fatigue Syndrome (CFS&ANS) (POTS)
       Vanderbilt University, Nashville, TN                                     Added Aug 20, '09

13) Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
       University of Virginia, Charlottesville, VA                              Added Nov '09

14) Study To Assess The Clinical Benefit Of Droxidopa In Subjects With CFS
       Chronic Fatigue Syndrome

       Hunter-Hopkins Center, Charlotte, NC                              Added Aug '10

15) The Expressive Writing Paradigm: A Study of Therapeutic Effectiveness for Chronic Pain
       University of Maryland, MD                                               Added Nov '12


1) The College of Health Professions at Temple University in Philadelphia

    Pregnancy in Fibromyalgia Questionnaire Study; Participants accepted ~ mid 2007

Women in the 6th or 7th month of pregnancy between the ages of 21 and 45 may be eligible for a research study to compare functional status in pregnant women with Fibromyalgia and pregnant women without Fibromyalgia. Benefits include a better understanding of how Fibromyalgia affects pregnancy. The study involves only the completion of two questionnaires so can be done from home. Participants will receive a gift certificate to Walmart.
Dr. Karen Moore Schaefer, RN, at (215) 707-4626 or karen.schaefer@temple.edu


2) The Center for Community Research at DePaul University:
    ME/CFS in children and adolescents.


In order to determine a diagnosis of Pediatric ME/CFS, the child must report fatigue as well as classic ME/CFS symptoms in each of the following categories for a duration of at least 3 months in addition to a frequency and severity rating:

Classic ME/CFS Symptom Category

a. fatigue
b. Post-exertional malaise
c. Sleep
d. Pain - At least one symptom from: Myofascial, Joint, Abdominal, or Head pain
e. Neurocognition - At least two symptoms
f. Other Category - At least one symptom from two of the following three categories:

    Autonomic manifestations:
    Neuroendocrine manifestations:
    Immune manifestations:

We are looking for children and adolescents ages 5-17 and their parents/guardians to complete the DePaul Pediatric Health Questionnaire (DPHQ).

* The DPHQ is a short questionnaire and will take about 30 minutes to complete
* Participation and answers will be kept confidential
* You can either mail the questionnaire back to us or we can pick it up.
   Your time and voluntary assistance are needed and appreciated.

If you and your child are interesting in volunteering, please contact:

Lindsay Till
Email: ltill@depaul.edu
Telephone: (773) 325-1897

Research Team's website: http://condor.depaul.edu/~ljason/cfs/
Principal Investigator: Leonard Jason, PhD
Enrollment will take place at least until the end of 2006.
Advertised with permission from DePaul IRB.

A significant problem in ME/CFS Research is the lack of both a pediatric definition of ME/CFS and a reliable instrument to assess it. The DPHQ was developed as a response to these problems.  It is hoped that findings from this study will help to develop an accurate case definition of ME/CFS in young people and that the DPHQ will become an instrumental tool for correctly identifying cases of Pediatric ME/CFS.


3) Psychosocial Treatment Trial for Multi-Symptom Illness, FM, CFS, IBS, TMJ, MCS
     Robert Wood Johnson Medical School, central NJ.

Study subjects must live within traveling distance of the test site.
Begins October 2006; no enrollment closing date has been set.

Dr. Lesley Allen  is recruiting participants who are bothered by multiple, persistent physical symptoms (such as pain, fatigue, gastrointestinal difficulties or menstrual difficulties) OR participants who have Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome, Temporo-Mandibular Joint Disorders, or Chemical Sensitivities for a free treatment study:

To examine a new psychosocial treatment designed to help reduce physical discomfort.

Based on the idea that stress tends to make physical symptoms worse, the program teaches stress management and coping skills as a way to reduce physical discomfort.

Applicants must be between the ages of 18 and 65 and must be experiencing multiple, unexplained physical symptoms. Medications must be stable for at least two months, and applicants must not be involved in (or be willing to delay) psychotherapy treatment during the four-month duration of the study.

The 14 weekly sessions will be offered at no cost to participants. They will be compensated $20 for each completed assessment.

For more information, contact Jade Tiu, Research Coordinator, tiuje@umdnj.edu
(732) 235-3378; 671 Hoes Lane, Piscataway, NJ 08854




4) Insomnia Medication Trial or FM Patients
     Robert Wood Johnson Medical School, central NJ.

Study subjects must live within traveling distance of the test site.
Begins October 2006; no enrollment closing date has been set.


Dr. Lesley Allen at is recruiting Fibromyalgia patients who are also experiencing sleeping difficulties for a medication study:

To examine the effects of a sleep medication as a treatment for insomnia and Fibromyalgia symptoms.

Applicants must be between the ages of 18 and 64, have been diagnosed with Fibromyalgia, and be stable on medications for at least one month. Additionally, applicants must not be involved in (or be willing to delay) psychotherapy treatment during the duration of the study.

The study involves 7 visits for approximately 4 months. All study pills and procedures are free of charge and participants will be compensated $20 for each completed visit.

For more information, contact Jade Tiu, Research Coordinator, tiuje@umdnj.edu
(732) 235-3378; 671 Hoes Lane, Piscataway, NJ 08854



5) Study of Ampligen in Chronic Fatigue Syndrome: Recruiting Once Again
http://www.clinicaltrials.gov/ct/show/NCT00215813
Updated October 24, 2006. Still recruiting in 2009

Sharon Conway
215-988-0080   
sharon@hemispherx.net

Study chairs or principal investigators

Daniel Peterson, M.D.,  Principal Investigator,  Sierra Internal Medicine, NV
Lucinda Bateman, M.D.,  Principal Investigator,  Fatigue Consultation Clinic, UT
Charles W. Lapp, M.D.,  Principal Investigator,  Hunter-Hopkins Center, NC



6) A Study of Genetic Risk Factors That May Be Associated
      with Chronic Fatigue Syndrome (CFS)


Researchers at the University of Illinois at Chicago and Tufts University are interested in YOU

Dr. Brigitte Huber of Tufts University and Dr. Renee Taylor of University of Illinois at Chicago are seeking research participants ages 13-64 for a study of genetic risk factors that may be associated with chronic fatigue syndrome. To be eligible, subjects should have documentation of a diagnosis of either chronic fatigue syndrome or mononucleosis from a physician.

If interested, please contact
Dr. Renee Taylor at 
(312) 996-3412 (office)
or mono@uic.edu.

[The JPG flyer for the study also lists the logos of NIH and Children's Memorial Hospital.]



 
7) Chronic Fatigue Study Questionnaire Study
       University of Utah                                                      
       Long distance participants welcome.

Do you have chronic fatigue and are you searching for ways to manage it better?  Have you just begun treatment with a new physician?  If yes, then medical researchers at the University of Utah invite you to participate in a research project. They want to study patients with chronic fatigue as well as the various methods that are currently being used to treat it. It requires you to complete 2 questionnaires, one before you start your treatment and another in about 6 months. It takes about 35 minutes of your time.  Through this project, the researchers hope to find better ways of treating chronic fatigue.  If you are interested in participating in this study and need more information please contact
Kate Hak, Research Coordinator, Health Services Research, University of Utah, at
(801) 587-4741 or email kate.hak@hci.utah.edu.

There will be no costs to you for participating in the study.

We will send you $25 if you complete two questionnaires, one given to you at the time you enroll and a second given to you three months later. We will send another $25 to you for completing a questionnaire six months after you enroll. If you need to get results of your laboratory tests from physicians other than the physician who told you about this study, we will give you an additional $15 for giving us the results of all of these tests.

See also
http://clinicaltrials.gov/ct2/show/NCT00983502

Added 10-2-08.
Email address and contact name updated 12-09.


 

8) Vulvodynia - Cost of Illness Survey 

The NVA is seeking women with vulvodynia who live in the United States to participate in a cost of illness survey, which asks questions about lost work hours and out-of-pocket expenses related to having vulvodynia. From a cost of illness survey, analysts can calculate to what extent a particular health condition impacts our economy. It is important for NVA to have this information to convince members of Congress and NIH staff of the great need to increase funding of vulvodynia research.
 
Participation requires only 3 hours of your time over the next 6 months. With the use of a NVA-supplied calendar, you will keep track of your vulvodynia-related expenses, such as prescription medications, doctor visits and over-the-counter remedies. Participants will anonymously log onto NVA's web site once every four weeks (for six months) to record expenses. Each time you log on, the survey will take 5-10 minutes to complete.
 
For additional information, or to participate, please visit http://www.nva.org/costsurvey
(Study Announced 9/24/08)



9)  Fibromyalgia with Sleep Disturbances - medication trial
       Raleigh, NC                                                                    Added Aug 20, '09
      
http://centerwatch.com/clinical-trials/listings/studydetails.aspx?StudyID=157049
Balance is a condition inherent to nature, but balance is hard to achieve in everyday life.
Occasional lack of sleep can affect your overall well being. But if you frequently wake up in the morning, after a night of fitful or disturbed sleep, with widespread muscle pain that lasts through the day, you could have a condition called Fibromyalgia.
Qualified participants will receive study medication and all study-related tests are no cost and may be compensated for time and travel.

You may qualify for this study if:

You are between the ages of 18 to 64

Maintain a normal daytime/awake, nighttime/asleep schedule including 6 to 8 hours in bed at night
Have been diagnosed with Fibromyalgia, or regularly experience the symptoms associates with the condition, including muscle pain, stiffness, headache and fatigue

Have experienced difficulty sleeping for least three days out of the week

Patient Exclusion Criteria: over age 64

Wake Research Associates
3100 Duraleigh Road, Suite 304
Raleigh, NC 27612
Phone: 919-781-2514
EMail: cmoore@wakeresearch.com




10)  Fibromyalgia, Juvenile - Clinical Trial Testing the Safety and Efficacy of Fluoxetine 
       Cincinnati, OH                                                                  Added Aug 20, '09
       Long distance participants welcome.

http://www.clinicaltrials.gov/ct2/show/NCT00115804

Contact: Megan Clayton    513-475-8113    claytoma@ucmail.uc.edu


Detailed Description:

Fibromyalgia is a common condition that is often challenging to treat. It is defined by the American College of Rheumatology (ACR) as widespread pain of at least 3 months duration in combination with tenderness at 11 or more of 18 specific tender point sites on the body. The prevalence of JPFS in children and adolescents in the general population of the United States is unknown. Studies from Israel, Mexico, and Italy have estimated that the prevalence rate of JPFS in school children ranges from 1.24% to 6.20%, with girls making up the majority of cases. Information from a national registry in the United States indicates that JPFS accounts for about 7.7% of new patient diagnoses in a pediatric rheumatology setting. The mean age of onset of pediatric JPFS is 12 years.

As in adults, JPFS has been diagnosed in children and adolescents using the ACR criteria. JPFS often leads to substantial morbidity and disability. For example, adolescents with JPFS reported significantly greater functional disability and greater number of school absences than those with other rheumatic diseases such as juvenile RA or lupus. The presence of high levels of pain and disability at this critical developmental stage place adolescents with JPFS at greater risk for long term social and occupational difficulties. Early diagnosis and effective intervention are therefore of critical importance.

Inclusion Criteria:

Female or male outpatients 13 to 18 years of age.
Fulfillment of the American College of Rheumatology (ACR) criteria for primary fibromyalgia.
Ability to understand and cooperate with study procedures.
Provision of parental written informed consent and verbal and written assent from the adolescent for participation in the study.


11)  Coping Skills Training for Adolescents With Fibromyalgia
       Kentucky and OH                                                                  Added Aug 20, '09
       Long distance participants welcome.
Juvenile fibromyalgia is a chronic pain condition that can cause considerable suffering and difficulty in an adolescent's day-to-day activities. The purpose of this study is to determine whether coping skills training, when combined with usual medical care, can reduce pain and disability in adolescents with fibromyalgia.

Study hypotheses: 1) Adolescents who receive coping skills training combined with their usual medical care will show significantly greater reductions in functional disability, pain, and depressive symptoms at the end of the acute treatment phase than adolescents who receive fibromyalgia education with their usual medical care. 2) Adolescents who receive coping skills training with their usual medical care will show significantly lower levels of functional disability, pain, and depressive symptoms at the end of a six-month maintenance phase than adolescents who receive fibromyalgia education with their usual medical care.

http://www.clinicaltrials.gov/ct2/show/NCT00086047

Inclusion Criteria:
Diagnosis of JPFS based upon widespread pain for over 3 months, at least 5 tender points, and associated features such as sleep difficulty, fatigue, and abdominal discomfort
Average pain intensity greater than 4 on the Visual Analog Scale
Functional disability score greater than 7
Stable medications for 8 weeks prior to study entry

Contact: Susmita Kashikar-Zuck, PhD    513-636-6337    Susmita.Kashikar-Zuck@cchmc.org

Kentucky and OH



12) Autonomic Nervous System and Chronic Fatigue Syndrome (CFS&ANS) (POTS)
       Vanderbilt University, Nashville, TN                                     Added Aug 20, '09

The investigators propose to test the hypothesis that the sympathetic nervous system contributes to the cardiovascular and inflammatory abnormalities present in the chronic fatigue syndrome (CFS) and, in particular in the subset of patients characterized by postural tachycardia syndrome (POTS). CFS and POTS are seen mostly in otherwise normal young women, and are the cause of significant disability. A substantial proportion of patients referred for evaluation of POTS met diagnostic criteria for CFS and, conversely, a subset of patients referred for treatment for CFS have POTS. The investigators hypothesize that sympathetic activation underlies the pathophysiology of patients in whom CFS and POTS overlap (CFS-P).

Other: Autonomic Function Tests
Other: Saline infusions
Drug: L-NMMA trimethaphan
Drug: methyldopa


Opened Dec 2007, still recruiting 11/12
clinicaltrials.gov/ct2/show/NCT00580619

Ages Eligible for Study:      18 Years to 65 Years
Genders Eligible for Study:      Both
Accepts Healthy Volunteers:      Yes
Criteria
Inclusion Criteria:
Meet CDC diagnostic criteria of CFS (Fukuda et al., 1994)
Meet diagnostic criteria of POTS (Raj et al., 2005)
Age between 18-65 years
Male and female are eligible (although majority of patients with CFS-P are female)

Contact: Ginnie Farley, RA         adcresearch@vanderbilt.edu




13) Cranial Electrical Stimulation Effects on Symptoms in Persons With Fibromyalgia
       University of Virginia, Charlottesville, VA                              Added Nov '09


Detailed Description:

Central pain networks in the brain are dysregulated in persons with fibromyalgia (FM). Thus, the investigators propose that cranial electrical stimulation (CES) that works on the brain may ameliorate symptoms of FM by interacting with the central pain networks. The specific aims of this randomized, controlled, three-group pilot study design are to: (1) determine differences in pain over time between the active CES, sham device, and usual care (UC) groups; (2) explore differences in brain activity in pain processing regions (i.e., cingulate, insula, prefrontal and somatosensory cortices, amygdala, and thalamus) between the active CES, sham device, and UC groups in a subset of 12 participants (6 in each device group); (3) determine the effects of CES on other symptoms (fatigue, sleep disturbances, depression, perceived stress) and functional status, and blood pressure over time between the active CES, sham device, and UC groups; and (4) determine the amount of influence that selected psychological factors (negative affect, catastrophizing, and other personality characteristics) have on group differences in pain, other symptoms, functional status, and brain activity.

http://clinicaltrials.gov/ct2/show/NCT00928720

Inclusion Criteria:
meet the diagnostic criteria for FM established by the American College of Rheumatology
have initial pain level equal to or greater than 3 on a NRS 0-10
have stable medication use related to FM for at least 4 weeks
be able to read, write, and understand the English language

Exclusion Criteria (all participants):
pregnant or breastfeeding
epilepsy or history of seizures
presence of pacemakers and/or other implanted devices

Exclusion Criteria (subset of 12 participants who wil have fMRIs)
conditions that would not permit an fMRI (e.g., certain types of metal or metallic objects in body, diaphragm or intrauterine device, dermal patches, ear or eye implants, implanted electrical stimulators, artificial heart valve, implanted catheter or tube, tattoos, claustrophobia; or weight more than 275 lbs)

Contact: Principal Investigator:
                Ann G Taylor, EdD, RN            434-924-0113    cscat@virginia.edu
Contact: Cheryl Bourguignon, PhD, RN    434-924-0082    cb2n@virginia.edu

Additional information from one of our members who is participating:

The device being tested is an “Alpha Stim 100” which you can find out about on the internet. the contacts that they have listed there are not the person who you need to talk to – took me some time to get to the right person.  She is very nice!  Her name is Shannon Riedel, slr3q@virginia.edu. Her # is 434-982-0724.  Leave a message, and she will call back. She is at the UVA School of Nursing in the Center for the Study of Complementary & Alternative Therapies.




14) Study To Assess The Clinical Benefit Of Droxidopa In Subjects With CFS
       Chronic Fatigue Syndrome


This study is currently recruiting participants.
Verified by Chelsea Therapeutics, July 2010
ClinicalTrials.gov Identifier: NCT00977171
Phase II
http://clinicaltrials.gov/ct2/show/NCT00977171?term=droxidopa&rank=6



Purpose

A subset of patients suffering from chronic fatigue syndrome exhibit symptoms of neurally mediated hypotension. While the underlying pathophysiology of chronic fatigue syndrome is not precisely understood, a dysfunction of the autonomic nervous system is thought to play a role in this subset of patients. In several small studies, subjects within this subset have noted improvement in their chronic fatigue symptoms when treated for their neurally mediated hypotension. As droxidopa acts on the autonomic nervous system and has been shown to ameliorate symptoms of neurally mediated hypotension, it is hypothesized that droxidopa could aid in the treatment of chronic fatigue symptoms.

Neurally mediated hypotension has been associated with patients suffering from chronic fatigue syndrome. Droxidopa meanwhile has been approved in Japan for the treatment of the symptoms of neurogenic orthostatic hypotension. As such, it is hypothesized that regulating the autonomic nervous system in patients with Chronic fatigue syndrome may prove to be clinically beneficial.

Eligibility

Ages Eligible for Study:      18 Years to 65 Years
Genders Eligible for Study:      Both
Accepts Healthy Volunteers:      No

Criteria

SUBJECT SELECTION CRITERIA:
Female and male outpatients between 18-65 years of age;
Subjects must be diagnosed with chronic fatigue syndrome (Per Fukuda Criteria);
Subjects must have neurally mediated hypotension (NMH) or neurogenic orthostatic hypotension (NOH) (confirmed via Tilt table test);
Voluntarily read and sign an informed consent.

MAIN SUBJECT EXCLUSION CRITERIA:
Taking a direct acting vasoconstricting agent (i.e. ephedrine or midodrine)
- Patients taking vasoconstrictor agents such as ephedrine, or midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever is longer) prior to their baseline visit (Visit 2);
Taking anti-hypertensive medication for the treatment of high blood pressure
Women of childbearing potential who are not using a medically accepted contraception;
Subject Restrictions: see website

Contact: Charles W Lapp, M.D.    (704) 543-9692    cwlapp@drlapp.net
               Hunter-Hopkins Center, Charlotte, NC




15) The Expressive Writing Paradigm:
A Study of Therapeutic Effectiveness for Chronic Pain


This study is currently recruiting participants.

ClinicalTrials.gov Identifier: NCT01639196
http://clinicaltrials.gov/ct2/show/NCT01639196?%20term=NCT01639196&rank=1


The Expressive Writing Paradigm: A Study of Therapeutic Effectiveness for Chronic Pain

Purpose

The purpose of this study is to explore the effects of writing about chronic pain on mental and physical health. The effectiveness of two different types of brief online writing interventions will be explored in individuals with chronic pain, self-compassion writing and self-efficacy writing.

The study is completely online and involves completing 2 surveys and 3 writing exercises. Participants complete either a 20-minute survey or a 20-minute writing exercise once a week for five consecutive weeks. The purpose of the study is to better understand the experiences of individuals who suffer from chronic pain. Some people find writing as a way to record what happens to them or as a way to talk about difficult experiences. This is your chance to help others in pain and help teach researchers how to better treat chronic pain. All of your information will be kept confidential and your participation is completely voluntary.

Participants need to be at least 18 years old, experiencing pain on most days of the month for at least 6 months, and experiencing pain that isn't directly caused by a terminal condition (e.g., stage 4 cancer). If you are interested in participating in the study, please email chronicpainstudy@umd.edu.


Selected International ME/CFS and FMS Trials - Includes Web Questionnaire Surveys

May 2013 - Fibromyalgia Study by University of Tennessee
Dec 2011 - Chronic Fatigue Study to Learn Self-Help Skills
March 2010 - Clinical Trial Participant Survey - Do people join studies for health care?
March 2010 - How perceived doctor empathy is defined & its impact on those with CFS/ME?
2009-2010 - Cancer After Other Conditions
Oct 2009 - FM Wellness Project
Aug 2009 - Questionnaire - Florida Institute of Technology - Chronic fatigue
Sep 2008 - Questionnaire -  FM Assoc. UK - Fibromyalgia Patients with Cognitive Problems



May 2013 - Fibromyalgia Study by University of Tennessee


Likely open until Fall 2013 Jameson K. Hirsch, PhD, a Clinical Psychologist at East Tennessee State University is conducting an online survey on the effects of Fibromyalgia on daily life and feelings:

Little is known about the emotional status of individuals with Fibromyalgia; thus, your participation will help to raise awareness about Fibromyalgia and will help healthcare professionals to better understand how Fibromyalgia affects mental health.

Your participation entails filling out a short survey. Participation in this survey is completely voluntary and confidential. It will take about 30-45 minutes to complete the survey. I would greatly appreciate it if all individuals with Fibromyalgia would support the research by completing the survey on this link:

surveymonkey.com/s/help_us_learn_about_fibromyalgia

Thank you for your time and support. I greatly appreciate your assistance.

Please let me know if you have any questions.
Sincerely,
Jameson K. Hirsch, Ph.D.
Assistant Professor
Department of Psychology
East Tennessee State University
P.O. Box 70649
Johnson City, TN 37614
Phone: (423) 439-4463
Email: hirsch@etsu.edu





Dec 2011 - Chronic Fatigue Study to Learn Self-Help Skills


If you have chronic fatigue, you're invited to participate in a study funded by the National Institutes of Health to learn fatigue self-help skills.

Internet and Windows XP or later version of Windows required.

Participants will be paid up to $498.

No in-person visits required.
For further information call Elaine Beun, RN, at (855) 672-1900 or write
elainebeun@yahoo.com

IRB Approved: 10/14/2011
Expiration Date: 10/13/2012
CORIHS, Stony Brook University



March 2010 - March 2011 - CLINICAL TRIAL PARTICIPANT SURVEY

The purpose of this study is to determine if some people join clinical trials to receive access to healthcare.  This work will help researchers better understand the links between access to healthcare and clinical trail participation.

This study is being conducted by a researcher Carrie M. Lee MBA, a doctoral student at Walden University, carrie.lee@waldenu.edu. Dr. Leilani Endicott is the Walden University representative who can discuss further questions, 1-800-925-3368, extension 1210.

Walden University’s approval number for this study is 03-18-10-0363696 and it expires on March 17, 2011.

If you have participated in a clinical trial in the past year, or are currently participating in a clinical trial you are invited to participate in a web survey at

http://www.makesurvey.net/cgi-bin/survey.dll/F688F42CE1DB4763B28F4B88FC5F6C34

No Identifying information is collected in this survey, and results are only used for this research project.





March 2010
How perceived doctor empathy is defined & its impact on those with CFS/ME?


How understanding is your Doctor?

Do you suffer from CFS / ME and want your views heard?

I am an MSc student at the University of St Andrews currently
researching the experiences of those with CFS/ME, with particular emphasis
on the role of patient-provider communication. This brief online
questionnaire aims to look at whether there is any direct impact from the
experiences you may receive from within your primary health care contact
on you, as someone with CFS/ME.

It is hoped that this study will illustrate the impact of understanding
CFS/ME within the healthcare profession in order to tailor training for
future physicians.

If you are still interested, please click on the link below:
http://www.surveymonkey.com/cfsonlinesurvey
Thank you!
Ceara Hayden
cearahayden@googlemail.com

If you have more questions directly relating to the study, feel free to contact:

Prof Gerry Humphris,
The Bute Medical School,
University of St Andrews,
Bute Building,
St Andrews
KY16 9TS
Scotland
gmh4@st-andrews.ac.uk





2009-2010 - Cancer After Other Conditions


THE UNIVERSITY OF TEXAS AT AUSTIN SCHOOL OF NURSING

Are you a cancer survivor who had limitations in activities of daily living prior to your cancer?

I invite you to participate in a study to help us understand how cancer survivors who had a functional limitation or disability prior to being diagnosed with cancer take care of their health. You can earn up to $ 25 by completing a questionnaire packet.  If you are over the age of 21, and interested in participating in this study, please complete the information requested on this page, fold it so the envelope on the back is showing, and mail it back to me. You can also fax it to 512-475-8755 or call 1-800-687-8010 (free), 512-232-3492. You must have completed active treatment to participate.

Heather Becker, Ph.D. -- The University of Texas at Austin, School of Nursing
heatherbecker@mail.utexas.edu

Send

What is your cancer diagnosis? ______________________________
Have you completed active treatment?          ____ yes         ____ no
Are you limited in any way in any activities because of physical, mental, or emotional problems?         ____ yes         ____ no

Did this functional limitation exist PRIOR to your cancer diagnosis?    ____ yes       ____ no

Name______________________________ Email____________________
Address____________________________________________________
City/State/Zip_______________________________________________
Phone ________________________         Date of Birth ____/____/_______

See also,
http://www.utexas.edu/nursing/html/research/news/09/cancer.html




Oct 2009 - FM Wellness Project

http://www.fmwellness.org/index.htm

The Fibromyalgia Wellness Project is a research study sponsored by NIAMS of NIH. This project is conducted by Collinge and Associates, an independent research group directed by William Collinge, PhD. 

Description

One way the person with FM may be able to have significant impact is through the careful management of lifestyle and behavior factors that affect symptom levels. However, since each person is unique, management of FM needs to be highly individualized.

Because there are so many options and influences to consider, one challenge is discovering what strategies work best. The purpose of the FM Wellness Project is to evaluate a completely individualized approach to symptom reduction. The goal is to empower users with uniquely personal insights into what strategies work best for them over time.

Participation involves visiting this website several times each week, about 5-10 minutes each time, to complete the SMARTLog. “SMART” is an acronym meaning Self-Monitoring and Review Tool. Like a diary, the SMARTLog records your activities, treatments, strategies, stresses, other inputs you want to evaluate, and your symptom levels for the past 24 hours.

By completing the SMARTLog several times each week you build a personal database over time. This project is pioneering a new statistical analysis approach that will evaluate your personal data each week to discover patterns of connection between your inputs and your symptom levels. When these patterns are found they are reported to you in your unique SMART Profile. The purpose of SMART Profile is to give you accurate, personalized feedback based on your own data, and no one else’s, about what inputs lead to reduced symptom levels for you.

Benefits

You may discover new ways to reduce your symptoms and improve the quality of your life.
You will be contributing to knowledge that may help others living with fibromyalgia.

Eligibillity

Adults (over 18) with fibromyalgia.
You must be able to read English and complete the assessment forms on this website.
You must have daily access to the internet at home to use SMARTLog.

The Consent Form which gives full details about participation.





Aug 2009 - Questionnaire - Florida Institute of Technology - Chronic fatigue

The National Chronic Fatigue Survey, an internet-based survey of fatigue related to chronic illness, has been launched by the Fatigue Management Institute of Florida Institute of Technology.  The survey is designed to gather information on the nature and impact of fatigue associated with chronic medical disorders.  The survey findings will be used to better describe the experience and severity of fatigue related to chronic medical conditions and will contribute to the development of improved techniques for managing fatigue.
 
The Survey is open to adults with a chronic medical condition, can be completed anonymously, and can be accessed at:

http://research.fit.edu/fmi
 

-- Summaries of findings will be posted on FIT web site following close of the survey.

-- The data collected is for research purposes only.
-- Participants' personal information will remain completely confidential.

-- Please aid us in developing a better understanding of fatigue in chronic medical conditions and in the eventual improvement of treatments and techniques for managing fatigue.

About the Fatigue Management Institute:
 
The Fatigue Management Institute serves as a focal point for integrating emerging research findings with techniques for day-to-day management of fatigue.  The Institute conducts research on fatigue and fatigue management interventions, provides fatigue management training, and disseminates summaries of research findings related to fatigue and its management in chronic medical conditions.  The institute is part of the School of Psychology at Florida Institute of Technology and has no commercial interests.  For further information contact Dr. Thom Harrell - tharrell@fit.edu
________________________________________________________________
School of Psychology
Florida Institute of Technology
150 West University Boulevard
Melbourne, FL 32901-6975
(321) 674-8104






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Updated May 10, 2013