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Brain Rhythms in Fibromyalgia: A Magnetoencephalography (MEG) Study (FMP)

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ClinicalTrials.gov Identifier: NCT02159300
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

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.


Condition or disease Intervention/treatment
Fibromyalgia Behavioral: experience brain activity recording

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Brain Rhythms in Fibromyalgia: A Magnetoencephalography (MEG) Study
Study Start Date : December 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Group/Cohort Intervention/treatment
Patients
Patients with fibromyalgia pain Intervention: experience brain activity recording
Behavioral: experience brain activity recording
Intervention: experience brain activity recording
Other Name: Change in pain level

Healthy Controls
Healthy controls without chronic pain of any type.
Behavioral: experience brain activity recording
Intervention: experience brain activity recording
Other Name: Change in pain level




Primary Outcome Measures :
  1. Spectral Power of brain magnetic activity [ Time Frame: Expected average of one week after MEG recoring ]
    The power of brain activity in the delta, theta, alpha, beta and gamma frequency ranges.


Secondary Outcome Measures :
  1. Brain location of electromagnetic sources of activity [ Time Frame: Expected average of one month after MRI ]
    The part of the brain with activity in the delta, theta, alpha, beta, and gamma frequency ranges.


Other Outcome Measures:
  1. Pain scores on the Visual Analogue Scale [ Time Frame: At time of magnetic recording ]
    Level of pain during recording using visual analogue scale (1-10) as reported by the patient.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women with fibromyalgia pain in the greater New York City area.

Pain-free women in the greater New York City area.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159300


Locations
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United States, New York
NYU Center for the Study & Treatment of Pain
New York, New York, United States, 10016
NYU School of Medicine; Center for Neuromagnetism
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Rodolfo R Llinas, MD, PhD NYU Langone Health

Publications:

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02159300     History of Changes
Other Study ID Numbers: WS697348
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015

Keywords provided by NYU Langone Health:
Fibromyalgia
Pain

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases