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

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ClinicalTrials.gov Identifier: NCT02662270
Recruitment Status : Recruiting
First Posted : January 25, 2016
Last Update Posted : September 18, 2017
Sponsor:
Collaborator:
Universidad de Murcia
Information provided by (Responsible Party):
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.

Condition or disease
Fibromyalgia

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.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Quantitative and Qualitative EEG From Fibromyalgia Patients for the Identification of Abnormal Patterns on Closed Eyes EEG
Actual Study Start Date : January 2017
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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.



Primary Outcome Measures :
  1. Differences between groups in Fast Fourier Transformation [ Time Frame: Up to one year ]
    Changes in Power in EEG over different electrodes

  2. Topographic distribution of the frequency bands [ Time Frame: Up to one year ]
    Brain areas with a characteristic pattern

  3. Dominant EEG frequency localization [ Time Frame: Up to one year ]
    To document the dominant frequency in the resting EEG for all subjects

  4. Abnormal EEG-graphoelements description [ Time Frame: Up to one year ]
    To identify the abnormal EEG-graphoelements found in fibromyalgia patients

  5. Functional conectivity [ Time Frame: Up to one year ]
    To identify the different brain connections between fibromyalgia patients



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662270


Contacts
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Contact: Moises Aguilar-Domingo, PhD +34634548720 moisor@icloud.com

Locations
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Spain
Universidad de Murcia Recruiting
Murcia, Spain
Contact: Ramón Martín-Brufau, PhD    968278806      
Sponsors and Collaborators
Spanish Foundation for Neurometrics Development
Universidad de Murcia
Investigators
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Principal Investigator: Moises Aguilar-Domingo, PhD Fundación Española para el Desarrollo de la Neurometria (Brainmech)

Publications of Results:
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Responsible Party: Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier: NCT02662270     History of Changes
Other Study ID Numbers: Fibromyalgia and TDCs
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Spanish Foundation for Neurometrics Development:
Fibromyalgia
QEEG
Brain activity
fMRI
Diagnosis

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases