Clinical trial NCT02662270: QEEG and Qualitative EEG for the Identidification of Abnormal Patterns in Fibromyalgia Patients
Official title: Quantitative and Qualitative EEG From Fibromyalgia Patients for the Identification of Abnormal Patterns on Closed Eyes EEG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: Fibromyalgia
QEEG
Brain activity
fMRI
Diagnosis
Lead sponsor: Spanish Foundation for Neurometrics Development
Sponsor class: OTHER
Collaborators: name: Universidad de Murcia
First posted: 2016-01-25
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences between groups in Fast Fourier Transformation
timeFrame: Up to one year
measure: Topographic distribution of the frequency bands
timeFrame: Up to one year
measure: Dominant EEG frequency localization
timeFrame: Up to one year
measure: Abnormal EEG-graphoelements description
timeFrame: Up to one year
measure: Functional conectivity
timeFrame: Up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad de Murcia
Study officials:
affiliation: Brainmech Foundation
name: Moises Aguilar-Domingo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Branco J, Atalaia A, Paiva T. Sleep cycles and alpha-delta sleep in fibromyalgia syndrome. J Rheumatol. 1994 Jun;21(6):1113-7.
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.
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 Aug 7.
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.
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.
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.2014.09.007. eCollection 2014.