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Brain Rhythms in Fibromyalgia: A Magnetoencephalography (MEG) Study

NCT02159300 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2015-10-07

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

BEHAVIORAL

experience brain activity recording

Intervention: experience brain activity recording

Sponsors & Collaborators

Principal Investigators

  • Rodolfo R Llinas, MD, PhD · NYU Langone Health

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02159300 on ClinicalTrials.gov