QEEG and Qualitative EEG for the Identidification of Abnormal Patterns in Fibromyalgia Patients

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT02662270
• Lead Sponsor: Spanish Foundation for Neurometrics Development

Brief Summary

Fibromyalgia is a relatively young condition recently recognized by the WHO as a separated clinical entity. Part of the medical comunity thinks of it as a mixed condition between depresion and rheumatic pain, however, functional data provided by sophisticated imaging techniques points at a diminished brain activity in several brain regions. The present study aims to characterize those findings by means of QEEG in order to establish the electroencephalographic characteristics of fibromyalgia patients.

Detailed Description

Fibromyalgia is a disease that part of the general population and even the medical community views with skepticism and only recently was accepted as a true condition by the World Health Organization. Some physicians see it as a form of depresion mixed with rheumatic pain. However recent findings in functional magnetic resonance imaging and positron emited tomography documented diminished brain activity on several regions. The impairments must be located within the areas with a documented functional defect, wherein, spontaneous braincells activity chould arise. Therefor electroencephalography findings should be a valuable diagnostic tool for early detection in fibromyalgia. The present study aims to analyse the differences between bioelectric characteristics in EEG from fibromyalgia patients with their eyes closed in a 21 electrode arragement. Normal graphoelements as well as abnormal ones and its topographic distribution and functional conections will be analyzed.

The working hypotesis is that fibromyalgia patients will present distintive characteristics in the same areas where a diminished brain activity has been documented by metabolic and morphologic tests as a group and that those characteristics are suitable to be measured by QEEG and distinguishable from healthy subjects.

Study Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-25
• Study Start: 2022-03-01
• Primary Completion: 2023-01-30
• Study Completion: 2023-03-12
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-30
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Men and women between 20 and 70 years old, diagnosed with fibromyalgia and a control group matched by age and gender

Exclusion Criteria

• Any other concomitant neurologic disease or impairment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional conectivity	Up to one year	To identify the different brain connections between fibromyalgia patients
Differences between groups in Fast Fourier Transformation	Up to one year	Changes in Power in EEG over different electrodes
Abnormal EEG-graphoelements description	Up to one year	To identify the abnormal EEG-graphoelements found in fibromyalgia patients
Topographic distribution of the frequency bands	Up to one year	Brain areas with a characteristic pattern
Dominant EEG frequency localization	Up to one year	To document the dominant frequency in the resting EEG for all subjects

Trial Locations

Locations (1)

Universidad de Murcia; 🇪🇸 Murcia, Spain