FibromyalgiaQEEGFPNCT02662270
QEEG and Qualitative EEG for the Identidification of Abnormal Patterns in Fibromyalgia Patients
An observational study of Fibromyalgia, run by Spanish Foundation for Neurometrics Development at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 12 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Men and women between 20 and 70 years old, diagnosed with fibromyalgia and a control group matched by age and gender
Who cannot join
- Any other concomitant neurologic disease or impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, QEEG, Brain activity, fMRI, Diagnosis
- Medical subject headings
- Fibromyalgia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Differences between groups in Fast Fourier Transformation
Changes in Power in EEG over different electrodes
Measured: Up to one year
Topographic distribution of the frequency bands
Brain areas with a characteristic pattern
Measured: Up to one year
Dominant EEG frequency localization
To document the dominant frequency in the resting EEG for all subjects
Measured: Up to one year
Abnormal EEG-graphoelements description
To identify the abnormal EEG-graphoelements found in fibromyalgia patients
Measured: Up to one year
Functional conectivity
To identify the different brain connections between fibromyalgia patients
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start1 Mar 2022
- Primary completion30 Jan 2023
- Study completion12 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Foundation for Neurometrics Development
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Murcia
- Responsible party
- Sponsor
- Investigators
- Moises Aguilar-Domingo, PhD, Principal investigator, Brainmech Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662270
- Sponsor's protocol ID
- Fibromyalgia and TDCs
- Acronym
- QEEGFP
- Status last verified
- Jul 2023
- First submitted
- 19 Jan 2016
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Branco J, Atalaia A, Paiva T. Sleep cycles and alpha-delta sleep in fibromyalgia syndrome. J Rheumatol. 1994 Jun;21(6):1113-7.
PubMed 7932424Drewes 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.
PubMed 10556252Flodin 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.
PubMed 24998297Napadow 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.
PubMed 25606591Rains 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.
PubMed 12505558Schmidt-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.
PubMed 25379438
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative and Qualitative EEG From Fibromyalgia Patients for the Identification of Abnormal Patterns on Closed Eyes EEG
- ClinicalTrials.gov ID
- NCT02662270
- Acronym / sponsor ID
- QEEGFP / Fibromyalgia and TDCs
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, QEEG, Brain activity, fMRI, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Spanish Foundation for Neurometrics DevelopmentUniversity, hospital or other
- Collaborators
- Universidad de Murcia
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Men and women between 20 and 70 years old, diagnosed with fibromyalgia and a control group matched by age and gender
Key exclusion criteria (1 listed)
- Any other concomitant neurologic disease or impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences between groups in Fast Fourier Transformation
Time frame: Up to one year
Changes in Power in EEG over different electrodes
Topographic distribution of the frequency bands
Time frame: Up to one year
Brain areas with a characteristic pattern
Dominant EEG frequency localization
Time frame: Up to one year
To document the dominant frequency in the resting EEG for all subjects
Abnormal EEG-graphoelements description
Time frame: Up to one year
To identify the abnormal EEG-graphoelements found in fibromyalgia patients
Functional conectivity
Time frame: Up to one year
To identify the different brain connections between fibromyalgia patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Results publication: PubMed 7932424Branco J, Atalaia A, Paiva T. Sleep cycles and alpha-delta sleep in fibromyalgia syndrome. J Rheumatol. 1994 Jun;21(6):1113-7.
- Results publication: PubMed 10556252Drewes 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.
- Results publication: PubMed 24998297Flodin 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.
- Results publication: PubMed 25606591Napadow 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.
- Results publication: PubMed 12505558Rains 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.
- Results publication: PubMed 25379438Schmidt-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moises Aguilar-Domingo, PhD principal investigator
Brainmech Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Spanish Foundation for Neurometrics Development at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between groups in Fast Fourier Transformation (time frame: Up to one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02662270, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.