CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
experience brain activity recordingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02159300
NCT02159300N/ACompleted

Brain Rhythms in Fibromyalgia: A Magnetoencephalography (MEG) Study

NYU Langone Health·observational·Posted Jun 9, 2014·Updated Oct 7, 2015

In Brief

An observational study evaluating experience brain activity recording for Fibromyalgia. Completed, enrolled 40 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 9, 2014
Enrollment StartDec 1, 2010
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 12.1 years ago

Interventions

experience brain activity recordingbehavioral

Intervention: experience brain activity recording