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

Fibromyalgia Clinical Trial

— QEEGFP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662270
• Other study ID #: Fibromyalgia and TDCs
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: March 12, 2023

Study information

• Verified date: July 2023
• Source: Spanish Foundation for Neurometrics Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 12, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Locations

Country	Name	City	State
Spain	Universidad de Murcia	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Foundation for Neurometrics Development	Universidad de Murcia

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Branco J, Atalaia A, Paiva T. Sleep cycles and alpha-delta sleep in fibromyalgia syndrome. J Rheumatol. 1994 Jun;21(6):1113-7. — View Citation

Drewes AM. Pain and sleep disturbances with special reference to fibromyalgia and rheumatoid arthritis. Rheumatology (Oxford). 1999 Nov;38(11):1035-8. doi: 10.1093/rheumatology/38.11.1035. No abstract available. — View Citation

Flodin P, Martinsen S, Lofgren M, Bileviciute-Ljungar I, Kosek E, Fransson P. Fibromyalgia is associated with decreased connectivity between pain- and sensorimotor brain areas. Brain Connect. 2014 Oct;4(8):587-94. doi: 10.1089/brain.2014.0274. Epub 2014 A — View Citation

Napadow V, Harris RE. What has functional connectivity and chemical neuroimaging in fibromyalgia taught us about the mechanisms and management of 'centralized' pain? Arthritis Res Ther. 2014;16(5):425. doi: 10.1186/s13075-014-0425-0. — View Citation

Rains JC, Penzien DB. Sleep and chronic pain: challenges to the alpha-EEG sleep pattern as a pain specific sleep anomaly. J Psychosom Res. 2003 Jan;54(1):77-83. doi: 10.1016/s0022-3999(02)00545-7. — View Citation

Schmidt-Wilcke T, Ichesco E, Hampson JP, Kairys A, Peltier S, Harte S, Clauw DJ, Harris RE. Resting state connectivity correlates with drug and placebo response in fibromyalgia patients. Neuroimage Clin. 2014 Sep 16;6:252-61. doi: 10.1016/j.nicl.2014.09.0 — View Citation

Outcome

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