Fibromyalgia Clinical Trial
— FMPOfficial title:
Brain Rhythms in Fibromyalgia: A Magnetoencephalography (MEG) Study
The long-term purpose of the investigator's research is to understand the pathophysiological
basis of chronic pain. This will help provide a framework for the development of effective
treatments. The purpose of this specific study is to find if there are abnormal brain
rhythms in patients with fibromyalgia syndrome (FM) who are in pain since this will indicate
particular types of treatments.
FM is a disorder of the muscles and/or joints, and patients experience sever fatigue. FM
occurs more often in women than in men (3.4% of women, 0.5% of men). The diseases can appear
at any age, but in most of the cases it occurs in women of childbearing age. FM is
considered a chronic pain condition since the pain is persistent. Pain and tenderness can be
widespread throughout the body. FM patients are more sensitive to sound and pressure
stimulation than healthy controls, indicating that there may be changes in the brain. Also,
pain is made worse under conditions of stress.
Treatments for FM pain include life style changes such as exercise, dietary changes,
cognitive-behavioral therapy, medications and even surgery, but there is no accepted "best"
treatment. This is partly because the underlying cause of the pain is not well understood.
The design of this study is to record brain activity to find if there are abnormal brain
rhythms in people with FM that are not present in healthy adults of the same age.
Specifically, the investigators will test the hypothesis that constant low frequency
oscillations will be present in patients with chronic pain due to FM. This has been found in
people with other types of pain and is called Thalamocortical Dysrhythmia (TCD). The study
has two parts. In the first part, a complete medical history will be obtained, including a
description of the person's pain. In the second part the investigators will use
magnetoencephalography (MEG) to non-invasively record brain activity. The MEG data will be
analyzed in terms the presence of normal alpha rhythm and abnormal low and high frequency
oscillations. Each person will have an MRI so the investigators can localize the rhythms
recorded by the MEG in the person's brain using their MRI. The people who record and analyze
the MEG recordings will not know if the person is a healthy control or a FM patient. The two
parts will be joined to test the hypothesis and find if there is a correlation between the
people with abnormal low frequency brain rhythms and the presence or degree of pain.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - female from any racial/ethnic background - general good health, with no serious or unstable medical conditions - normal or corrected-to-normal vision and hearing - meets the American College of Rheumatology criteria for the diagnosis of fibromyalgia for at least 1 year - has had continued presence of pain for more than 50% of the last month - a score of >1 on the unidimensional 100-cm visual analog scale (VAS) for pain level - has been on a stable medication regimen for at least 3 weeks, with no change greater than +/- 20% variation on total daily dosage - 18-70 years of age - is right handed - willing to complete all study procedures - is capable of giving written informed consent Exclusion Criteria: - in-patient - a history of brain abnormalities such as stroke, ventriculomegaly or periventricular white matter abnormalities - has not been on a stable medication regimen for at least 3 weeks, with any change greater than +/- 20% variation on medication total daily dosage - has a history of substance abuse - has the presence of concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain - has concurrent participation in other therapeutic trials - pregnant and nursing mothers - has severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years) - or has current major depression. [Depression in these patients will be assessed with the Hospital Anxiety and Depression Scale (HADS). Categorization of fibromyalgia patients with high depressive symptoms is defined as >8 for the HADS - has contraindications for MRI scanning or MEG recording, including any of the following: cardiac pacemaker, intracranial clips, metal implants, or external clips within 10 mm of the head, metal in eyes, claustrophobia, obesity and/or any other reason leading to difficulty getting in the MEG chair or laying supine in the MRI magnet for up to one hour - Existence of any other chronic pain conditions, in addition to fibromyalgia |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | NYU Center for the Study & Treatment of Pain | New York | New York |
United States | NYU School of Medicine; Center for Neuromagnetism | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
United States,
Burgmer M, Pogatzki-Zahn E, Gaubitz M, Stüber C, Wessoleck E, Heuft G, Pfleiderer B. Fibromyalgia unique temporal brain activation during experimental pain: a controlled fMRI Study. J Neural Transm (Vienna). 2010 Jan;117(1):123-31. doi: 10.1007/s00702-009-0339-1. Epub 2009 Nov 25. — View Citation
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Jeanmonod D, Magnin M, Morel A. Thalamus and neurogenic pain: physiological, anatomical and clinical data. Neuroreport. 1993 May;4(5):475-8. Erratum in: Neuroreport 1993 Aug;4(8):1066. — View Citation
Llinás RR, Ribary U, Jeanmonod D, Kronberg E, Mitra PP. Thalamocortical dysrhythmia: A neurological and neuropsychiatric syndrome characterized by magnetoencephalography. Proc Natl Acad Sci U S A. 1999 Dec 21;96(26):15222-7. — View Citation
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Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497. — View Citation
Shiraishi H, Ahlfors SP, Stufflebeam SM, Takano K, Okajima M, Knake S, Hatanaka K, Kohsaka S, Saitoh S, Dale AM, Halgren E. Application of magnetoencephalography in epilepsy patients with widespread spike or slow-wave activity. Epilepsia. 2005 Aug;46(8):1264-72. — View Citation
Walton KD, Dubois M, Llinás RR. Abnormal thalamocortical activity in patients with Complex Regional Pain Syndrome (CRPS) type I. Pain. 2010 Jul;150(1):41-51. doi: 10.1016/j.pain.2010.02.023. Epub 2010 Mar 24. — View Citation
Weinberg H, Brickett PA, Vrba J, Fife AA, Burbank MB. The use of a squid third order spatial gradiometer to measure magnetic fields of the brain. Ann N Y Acad Sci. 1984;425:743-52. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain scores on the Visual Analogue Scale | Level of pain during recording using visual analogue scale (1-10) as reported by the patient. | At time of magnetic recording | No |
Primary | Spectral Power of brain magnetic activity | The power of brain activity in the delta, theta, alpha, beta and gamma frequency ranges. | Expected average of one week after MEG recoring | No |
Secondary | Brain location of electromagnetic sources of activity | The part of the brain with activity in the delta, theta, alpha, beta, and gamma frequency ranges. | Expected average of one month after MRI | No |
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