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

July 30, 2023 updated by: Spanish Foundation for Neurometrics Development

Quantitative and Qualitative EEG From Fibromyalgia Patients for the Identification of Abnormal Patterns on Closed Eyes EEG

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain
        • Universidad de Murcia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Men and women between 20 and 70 years old divided in two groups, one consisting in 50 subjects diagnosed with fibromyalgia acording to the current criteria of the American College of Rheumatology and a control group matched by age and gender without fibromyalgia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Cases
Patients with a fibromyalgia diagnosis established according to the American College of Rheumatology current criteria by a trained physician.
Controls
Healthy subjects paired by age and gender to the subjects in the cases group.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Foundation for Neurometrics Development

Collaborators

Universidad de Murcia

Investigators

  • Principal Investigator: Moises Aguilar-Domingo, PhD, Brainmech Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

March 12, 2023

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimated)

January 25, 2016

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 30, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fibromyalgia and TDCs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe