NCT02662270

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
6.1 years until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

January 19, 2016

Last Update Submit

July 30, 2023

Conditions

Fibromyalgia

Keywords

FibromyalgiaQEEGBrain activityfMRIDiagnosis

Outcome Measures

Primary Outcomes (5)

  • Differences between groups in Fast Fourier Transformation

    Changes in Power in EEG over different electrodes

    Up to one year

  • Topographic distribution of the frequency bands

    Brain areas with a characteristic pattern

    Up to one year

  • Dominant EEG frequency localization

    To document the dominant frequency in the resting EEG for all subjects

    Up to one year

  • Abnormal EEG-graphoelements description

    To identify the abnormal EEG-graphoelements found in fibromyalgia patients

    Up to one year

  • Functional conectivity

    To identify the different brain connections between fibromyalgia patients

    Up to one year

Study Arms (2)

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.

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Any other concomitant neurologic disease or impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Murcia

Murcia, Spain

Location

Related 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.

    PMID: 7932424RESULT

  • 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.

    PMID: 10556252RESULT

  • 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 Aug 7.

    PMID: 24998297RESULT

  • 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.

    PMID: 25606591RESULT

  • 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.

    PMID: 12505558RESULT

  • 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.2014.09.007. eCollection 2014.

    PMID: 25379438RESULT

MeSH Terms

Conditions

FibromyalgiaDisease

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Moises Aguilar-Domingo, PhD

    Brainmech Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 25, 2016

Study Start

March 1, 2022

Primary Completion

January 30, 2023

Study Completion

March 12, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Locations

ES(1)