FibromyalgiaNCT06905171
Habituation of Brain Responses to Sensory Stimuli in Fibromyalgia
An observational study of Fibromyalgia, run by National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
Trial summary
The goal of this observational study is to assess event-related potentials and habituation in patients with fibromyalgia. The main research questions are: Is there a measurable difference in sensory responses between fibromyalgia patients and healthy control? Could these measures provide evidence supporting claims of… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Auditory Stimulation, Visual Stimulation and Somatosensory Stimulation
- How many people
- 26 participants
- Where
- 1 siteArgentina
- Study dates
- 14 Mar 2025to 16 May 2025
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The cohorts of patients and healthy controls wil be selected from the city of Paraná and surrounding areas. Through the ONG "Fibromialgia Entre Ríos Asociación Civil", the patients will be reached out and asked wether or not they are willing to participate. Additionally, flyer will be hung in major health facilities in the city and made public on social media. The cohort of healthy volunteers will be recruited after the patients for age, genre and socieconomic matching
Who may be able to join
- Fibromyalgia patients:
- Primary diagnosis of fibromyalgia according to the criteria used by the healthcare professional in charge of the patient.
- Other comorbidities are accepted as long as the pain caused by them is less severe than the pain caused by fibromyalgia.
- Willingness and ability to fully understand the content and scope of the experiment and to comply with the experiment instructions.
- Normal or corrected-to-normal vision.
- Normal hearing
Show all 11Show fewer
- Healthy controls:
- No history of neurological diseases, chronic pain or musculoskeletal disorders.
- Willingness and ability to fully understand the content and scope of the experiment and to comply with the experiment instructions.
- Normal or corrected-to-normal vision.
- Normal hearing
Who cannot join
- Fibromyalgia patients:
- Pregnancy
- History of addictive behavior, defined as alcohol, cannabis, opioids or other drugs abuse.
- Presence of fever, tuberculosis, malignant tumors, infectious processes, acute inflammatory processes.
- Lack of cooperation
- Healthy controls:
Show all 11Show fewer
- Pregnancy
- History of chronic pain or musculoskeletal or articular disorders
- History of addictive behavior, defined as alcohol, cannabis, opioids or other drugs abuse.
- Presence of fever, tuberculosis, malignant tumors, infectious processes, acute inflammatory processes.
- Lack of cooperation
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Faculty of Engineering-National University of Entre Ríos
Oro Verde, Entre Ríos Province, 3100
About this study
Official title: Analysis of Brain Responses and Habituation to Multimodal Sensory Stimuli in Patients With Fibromyalgia
The goal of this observational study is to assess event-related potentials and habituation in patients with fibromyalgia. The main research questions are:
- Is there a measurable difference in sensory responses between fibromyalgia patients and healthy control?
- Could these measures provide evidence supporting claims of hypersensitivity?
Participants will:
- receive randomized sensory stimuli (auditory, visual, somatosensory, audiovisual, auditory-somatosensory, visual-somatosensory, and auditory-visual-somatosensory) in blocks of 20 trials.
Read the detailed description
Fibromyalgia is a disorder characterized primarily by widespread musculoskeletal pain. It is often accompanied by symptoms such as fatigue, insomnia, cognitive difficulties, etc. In addition to chronic pain, patients frequently report hypersensitivity to sensory stimuli, both nociceptive and non-nociceptive. Studies using psychophysical and electrophysiological tests have found altered sensory processing in fibromyalgia patients.
Research focused on event-related potentials (ERPs) have found differences in amplitude in the responses to auditory, nociceptive, and non-nociceptive somatosensory stimuli in fibromyalgia patients . One key aspect evaluated through ERPs is habituation, defined as a decrease in response due to repeated stimulation. In healthy individuals, ERPs amplitude decreases with repeated sensory input due to progressive neuronal response reduction. In fibromyalgia patients, reduced habituation has been observed for laser-induced ERPs and somatosensory ERPs, though no differences were found for auditory ERPs.
ERPs not only provide information about sensory modalities but also contain non-specific components related to stimulus expectation, motor preparation, and attentional orientation. Previous studies have attempted to isolate this non-specific component, as part of habituation may stem from a decrease in its amplitude rather than from a direct sensory response reduction. Using an analytical model, researchers successfully separated this component in experiments with individually or simultaneously presented stimuli, yielding promising results.
In the present study, participants (both fibromyalgia patients and healthy controls) will attend one experimental session in which stimulation in different sensory modalities will take place along with electroencephalographic (EEG) recordings. For each stimulus type, 2 blocks of 20 trials will be performed.The order of the stimulus will be selected randomly, but they can be divided into three categories:
- Unimodal stimulus
- Auditory (A): a 1000 Hz tone delivered at a comfortable volume through a speaker
- Visual (V): a checkerboard pattern, inverted every 25 ms, presented on a computer screen.
- Somatosensory (S): a train of 3 electrical stimuli that elicits a pricking sensation.
- Bimodal stimulus
- Auditory-Visual (AV)
- Auditivo-Somatosensory (AS)
- Visual-Somatosensory (VS)
- Trimodal Stimulus
- Auditory-Visual-Somatosensory (AVS) The aim of the study is to evaluate neurophysiological parameters related to habituation in multimodal sensory stimulation environments to characterize ERPs in fibromyalgia patients.
- Conditions
- Fibromyalgia
- Being tested
- Auditory Stimulation, Visual Stimulation, Somatosensory Stimulation, Auditory-Visual Stimulation, Visual-Somatosensory Stimulation
- Keywords
- Event-Related Potentials, Electroencephalography, Habituation
- Medical subject headings
- Fibromyalgia, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory StimulationOther
A tone at a 1000 Hz frequency, delivered through speakers at a comfortable volume
Visual StimulationOther
A checkerboard pattern displayed on a monitor, with colors alternating every 25 ms
Somatosensory StimulationOther
A train of three electrical stimuli, each lasting 1 ms, separated by 8 ms, at an intensity that clearly elicits a pricking sensation
Auditory-Visual StimulationOther
Stimulation using auditory and visual stimuli concomitantly
Visual-Somatosensory StimulationOther
Stimulation using visual and somatosensory stimuli concomitantly
Auditory-Somatonsensory StimulationOther
Stimulation using auditory and somatosensory stimuli concomitantly
Auditory-Visual-Somatosensory StimulationOther
Stimulation using auditory, visual and somatosensory stimuli concomitantly
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia Patients | Patients with primary fibromyalgia diagnosis. May include other chronic pain comorbidities, but the pain associated with those diseases should be less severe than the pain caused by fibromyalgia. Receives: Other: Auditory Stimulation; Other: Visual Stimulation; Other: Somatosensory Stimulation; Other: Auditory-Visual Stimulation; Other: Visual-Somatosensory Stimulation; Other: Auditory-Somatonsensory Stimulation; Other: Auditory-Visual-Somatosensory Stimulation | |
| Healthy Controls | Volunteers with no clinical history of chronic pain, musculoskeletal or articular disorders Receives: Other: Auditory Stimulation; Other: Visual Stimulation; Other: Somatosensory Stimulation; Other: Auditory-Visual Stimulation; Other: Visual-Somatosensory Stimulation; Other: Auditory-Somatonsensory Stimulation; Other: Auditory-Visual-Somatosensory Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentual Habituation
Relative reduction in the amplitude of evoked potentials between consecutive stimuli
Measured: Immediately after the intervention
Secondary outcomes (9)
Fibromyalgia Impact Questionnaire-Revised version (FIQR)
Instrument for the assessment and evaluation of fibromyalgia patient's status. Scores range from 0 to 100, with a higher number indicating more impacts of fibromyalgia symptoms in daily life
Measured: 10 minutes before the intervention
Symptoms Impact Questionnaire (SIQ)
Instrument to assess healthy control's status regarding relevant clinical symptoms experienced in the last week. Scores range from 0 to 100, with a higher number indicating more impacts of their symptoms in daily life activities
Measured: 10 minutes before the intervention
Hospital Anxiety and Depression Scale (HADS)
Widely used instrument to evaluate anxiety and depression. It is divided into 7 questions assessing anxiety and 7 assessing depression. The scores range from 0 to 21, with higher scores indicating worse clinical symptoms.
Measured: 10 minutes before the intervention
Numeric Rating Scale Pain (NRSp)
Pain at the moment of the experimental session. Scores range from 0 to 10, with higher number indicating worse pain.
Measured: 10 minutes before the intervention
Stimulus saliency
A number reflecting the ability of a stimulus to stand out relative to the sensory background or relative to the preceding stimuli
Measured: Immediately after the intervention
Event-related potentials amplitude
Amplitude, in microvolts, of event-related brain potentials
Measured: Immediately after the intervention
Event-related potentials latency
Latency, in milliseconds, of event-related brain potentials
Measured: Immediately after the intervention
Non-specific components amplitude
Amplitude, in microvolts, of the non/specific component derived from the ERPs
Measured: Immediately after the intervention
Non-specific components latency
Latency, in milliseconds, of the non-specific component derived from the ERPs
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start14 Mar 2025
- Primary completion16 May 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Council of Scientific and Technical Research, Argentina
- Sponsor type
- Other government
- Responsible party
- Principal investigator, José Biurrun Manresa, National Council of Scientific and Technical Research, Argentina
- Investigators
- Biurrun Manresa, Principal investigator, National Council of Scientific and Technical Research, Argentina (CONICET)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905171
- Sponsor's protocol ID
- IS004760
- Status last verified
- Aug 2025
- First submitted
- 25 Mar 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be made available on the 'Open Science Framework' after undergoing the process of anonymization to remove any participant-identifying information. The data will consist of the raw EEG signals and raw behavioral responses to cognitive tasks. Additionally, the statistical analysis and Jupyter notebooks used to process the data will also be shared
Publications
Gondan M, Roder B. A new method for detecting interactions between the senses in event-related potentials. Brain Res. 2006 Feb 16;1073-1074:389-97. doi: 10.1016/j.brainres.2005.12.050. Epub 2006 Jan 20.
PubMed 16427613Thompson RF, Spencer WA. Habituation: a model phenomenon for the study of neuronal substrates of behavior. Psychol Rev. 1966 Jan;73(1):16-43. doi: 10.1037/h0022681. No abstract available.
PubMed 5324565Montoya P, Sitges C, Garcia-Herrera M, Rodriguez-Cotes A, Izquierdo R, Truyols M, Collado D. Reduced brain habituation to somatosensory stimulation in patients with fibromyalgia. Arthritis Rheum. 2006 Jun;54(6):1995-2003. doi: 10.1002/art.21910.
PubMed 16732548Lorenz J. Hyperalgesia or hypervigilance? An evoked potential approach to the study of fibromyalgia syndrome. Z Rheumatol. 1998;57 Suppl 2:19-22. doi: 10.1007/s003930050228.
PubMed 10025076de Tommaso M, Federici A, Santostasi R, Calabrese R, Vecchio E, Lapadula G, Iannone F, Lamberti P, Livrea P. Laser-evoked potentials habituation in fibromyalgia. J Pain. 2011 Jan;12(1):116-24. doi: 10.1016/j.jpain.2010.06.004. Epub 2010 Aug 4.
PubMed 20685171Alanoglu E, Ulas UH, Ozdag F, Odabasi Z, Cakci A, Vural O. Auditory event-related brain potentials in fibromyalgia syndrome. Rheumatol Int. 2005 Jun;25(5):345-9. doi: 10.1007/s00296-004-0443-3. Epub 2004 Feb 21.
PubMed 14986061McDermid AJ, Rollman GB, McCain GA. Generalized hypervigilance in fibromyalgia: evidence of perceptual amplification. Pain. 1996 Aug;66(2-3):133-44. doi: 10.1016/0304-3959(96)03059-x.
PubMed 8880834Young EL, Mista CA, Jure FA, Andersen OK, Biurrun Manresa JA. An analytical method to separate modality-specific and nonspecific sensory components of event-related potentials. Eur J Neurosci. 2022 Oct;56(7):5090-5105. doi: 10.1111/ejn.15798. Epub 2022 Aug 31.
PubMed 35983754Staud R, Godfrey MM, Robinson ME. Fibromyalgia Patients Are Not Only Hypersensitive to Painful Stimuli But Also to Acoustic Stimuli. J Pain. 2021 Aug;22(8):914-925. doi: 10.1016/j.jpain.2021.02.009. Epub 2021 Feb 23.
PubMed 33636370Lim M, Roosink M, Kim JS, Kim HW, Lee EB, Son KM, Kim HA, Chung CK. Augmented Pain Processing in Primary and Secondary Somatosensory Cortex in Fibromyalgia: A Magnetoencephalography Study Using Intra-Epidermal Electrical Stimulation. PLoS One. 2016 Mar 18;11(3):e0151776. doi: 10.1371/journal.pone.0151776. eCollection 2016.
PubMed 26992095
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Brain Responses and Habituation to Multimodal Sensory Stimuli in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06905171
- Acronym / sponsor ID
- IS004760
- Conditions
- Fibromyalgia
- Keywords
- Event-Related Potentials, Electroencephalography, Habituation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Council of Scientific and Technical Research, ArgentinaOther government
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 1 Apr 2025 (actual)
- 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.
The goal of this observational study is to assess event-related potentials and habituation in patients with fibromyalgia. The main research questions are:
- Is there a measurable difference in sensory responses between fibromyalgia patients and healthy control?
- Could these measures provide evidence supporting claims of hypersensitivity?
Participants will:
- receive randomized sensory stimuli (auditory, visual, somatosensory, audiovisual, auditory-somatosensory, visual-somatosensory, and auditory-visual-somatosensory) in blocks of 20 trials.
Detailed description
Fibromyalgia is a disorder characterized primarily by widespread musculoskeletal pain. It is often accompanied by symptoms such as fatigue, insomnia, cognitive difficulties, etc. In addition to chronic pain, patients frequently report hypersensitivity to sensory stimuli, both nociceptive and non-nociceptive. Studies using psychophysical and electrophysiological tests have found altered sensory processing in fibromyalgia patients.
Research focused on event-related potentials (ERPs) have found differences in amplitude in the responses to auditory, nociceptive, and non-nociceptive somatosensory stimuli in fibromyalgia patients . One key aspect evaluated through ERPs is habituation, defined as a decrease in response due to repeated stimulation. In healthy individuals, ERPs amplitude decreases with repeated sensory input due to progressive neuronal response reduction. In fibromyalgia patients, reduced habituation has been observed for laser-induced ERPs and somatosensory ERPs, though no differences were found for auditory ERPs.
ERPs not only provide information about sensory modalities but also contain non-specific components related to stimulus expectation, motor preparation, and attentional orientation. Previous studies have attempted to isolate this non-specific component, as part of habituation may stem from a decrease in its amplitude rather than from a direct sensory response reduction. Using an analytical model, researchers successfully separated this component in experiments with individually or simultaneously presented stimuli, yielding promising results.
In the present study, participants (both fibromyalgia patients and healthy controls) will attend one experimental session in which stimulation in different sensory modalities will take place along with electroencephalographic (EEG) recordings. For each stimulus type, 2 blocks of 20 trials will be performed.The order of the stimulus will be selected randomly, but they can be divided into three categories:
- Unimodal stimulus
- Auditory (A): a 1000 Hz tone delivered at a comfortable volume through a speaker
- Visual (V): a checkerboard pattern, inverted every 25 ms, presented on a computer screen.
- Somatosensory (S): a train of 3 electrical stimuli that elicits a pricking sensation.
- Bimodal stimulus
- Auditory-Visual (AV)
- Auditivo-Somatosensory (AS)
- Visual-Somatosensory (VS)
- Trimodal Stimulus
- Auditory-Visual-Somatosensory (AVS) The aim of the study is to evaluate neurophysiological parameters related to habituation in multimodal sensory stimulation environments to characterize ERPs in fibromyalgia patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia Patients | – | Other: Auditory Stimulation, Other: Visual Stimulation, Other: Somatosensory Stimulation, Other: Auditory-Visual Stimulation, Other: Visual-Somatosensory Stimulation, Other: Auditory-Somatonsensory Stimulation, Other: Auditory-Visual-Somatosensory StimulationPatients with primary fibromyalgia diagnosis. May include other chronic pain comorbidities, but the pain associated with those diseases should be less severe than the pain caused by fibromyalgia. |
| Healthy Controls | – | Other: Auditory Stimulation, Other: Visual Stimulation, Other: Somatosensory Stimulation, Other: Auditory-Visual Stimulation, Other: Visual-Somatosensory Stimulation, Other: Auditory-Somatonsensory Stimulation, Other: Auditory-Visual-Somatosensory StimulationVolunteers with no clinical history of chronic pain, musculoskeletal or articular disorders |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The cohorts of patients and healthy controls wil be selected from the city of Paraná and surrounding areas. Through the ONG "Fibromialgia Entre Ríos Asociación Civil", the patients will be reached out and asked wether or not they are willing to participate. Additionally, flyer will be hung in major health facilities in the city and made public on social media. The cohort of healthy volunteers will be recruited after the patients for age, genre and socieconomic matching
Key inclusion criteria (11 listed)
- Primary diagnosis of fibromyalgia according to the criteria used by the healthcare professional in charge of the patient.
- Other comorbidities are accepted as long as the pain caused by them is less severe than the pain caused by fibromyalgia.
- Willingness and ability to fully understand the content and scope of the experiment and to comply with the experiment instructions.
- Normal or corrected-to-normal vision.
- Normal hearing
Key exclusion criteria (11 listed)
- Pregnancy
- History of addictive behavior, defined as alcohol, cannabis, opioids or other drugs abuse.
- Presence of fever, tuberculosis, malignant tumors, infectious processes, acute inflammatory processes.
- Lack of cooperation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory StimulationA tone at a 1000 Hz frequency, delivered through speakers at a comfortable volume | Other | Fibromyalgia Patients, Healthy Controls |
| Visual StimulationA checkerboard pattern displayed on a monitor, with colors alternating every 25 ms | Other | Fibromyalgia Patients, Healthy Controls |
| Somatosensory StimulationA train of three electrical stimuli, each lasting 1 ms, separated by 8 ms, at an intensity that clearly elicits a pricking sensation | Other | Fibromyalgia Patients, Healthy Controls |
| Auditory-Visual StimulationStimulation using auditory and visual stimuli concomitantly | Other | Fibromyalgia Patients, Healthy Controls |
| Visual-Somatosensory StimulationStimulation using visual and somatosensory stimuli concomitantly | Other | Fibromyalgia Patients, Healthy Controls |
| Auditory-Somatonsensory StimulationStimulation using auditory and somatosensory stimuli concomitantly | Other | Fibromyalgia Patients, Healthy Controls |
| Auditory-Visual-Somatosensory StimulationStimulation using auditory, visual and somatosensory stimuli concomitantly | Other | Fibromyalgia Patients, Healthy Controls |
Primary outcome
Percentual Habituation
Time frame: Immediately after the intervention
Relative reduction in the amplitude of evoked potentials between consecutive stimuli
9 secondary outcomes
Fibromyalgia Impact Questionnaire-Revised version (FIQR)
Time frame: 10 minutes before the intervention
Symptoms Impact Questionnaire (SIQ)
Time frame: 10 minutes before the intervention
Hospital Anxiety and Depression Scale (HADS)
Time frame: 10 minutes before the intervention
Numeric Rating Scale Pain (NRSp)
Time frame: 10 minutes before the intervention
Stimulus saliency
Time frame: Immediately after the intervention
Event-related potentials amplitude
Time frame: Immediately after the intervention
Event-related potentials latency
Time frame: Immediately after the intervention
Non-specific components amplitude
Time frame: Immediately after the intervention
Non-specific components latency
Time frame: Immediately after the intervention
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 14 Aug 2025.
- Background: PubMed 16427613Gondan M, Roder B. A new method for detecting interactions between the senses in event-related potentials. Brain Res. 2006 Feb 16;1073-1074:389-97. doi: 10.1016/j.brainres.2005.12.050. Epub 2006 Jan 20.
- Background: PubMed 5324565Thompson RF, Spencer WA. Habituation: a model phenomenon for the study of neuronal substrates of behavior. Psychol Rev. 1966 Jan;73(1):16-43. doi: 10.1037/h0022681. No abstract available.
- Background: PubMed 16732548Montoya P, Sitges C, Garcia-Herrera M, Rodriguez-Cotes A, Izquierdo R, Truyols M, Collado D. Reduced brain habituation to somatosensory stimulation in patients with fibromyalgia. Arthritis Rheum. 2006 Jun;54(6):1995-2003. doi: 10.1002/art.21910.
- Background: PubMed 10025076Lorenz J. Hyperalgesia or hypervigilance? An evoked potential approach to the study of fibromyalgia syndrome. Z Rheumatol. 1998;57 Suppl 2:19-22. doi: 10.1007/s003930050228.
- Background: PubMed 20685171de Tommaso M, Federici A, Santostasi R, Calabrese R, Vecchio E, Lapadula G, Iannone F, Lamberti P, Livrea P. Laser-evoked potentials habituation in fibromyalgia. J Pain. 2011 Jan;12(1):116-24. doi: 10.1016/j.jpain.2010.06.004. Epub 2010 Aug 4.
- Background: PubMed 14986061Alanoglu E, Ulas UH, Ozdag F, Odabasi Z, Cakci A, Vural O. Auditory event-related brain potentials in fibromyalgia syndrome. Rheumatol Int. 2005 Jun;25(5):345-9. doi: 10.1007/s00296-004-0443-3. Epub 2004 Feb 21.
- Background: PubMed 8880834McDermid AJ, Rollman GB, McCain GA. Generalized hypervigilance in fibromyalgia: evidence of perceptual amplification. Pain. 1996 Aug;66(2-3):133-44. doi: 10.1016/0304-3959(96)03059-x.
- Background: PubMed 35983754Young EL, Mista CA, Jure FA, Andersen OK, Biurrun Manresa JA. An analytical method to separate modality-specific and nonspecific sensory components of event-related potentials. Eur J Neurosci. 2022 Oct;56(7):5090-5105. doi: 10.1111/ejn.15798. Epub 2022 Aug 31.
- Background: PubMed 33636370Staud R, Godfrey MM, Robinson ME. Fibromyalgia Patients Are Not Only Hypersensitive to Painful Stimuli But Also to Acoustic Stimuli. J Pain. 2021 Aug;22(8):914-925. doi: 10.1016/j.jpain.2021.02.009. Epub 2021 Feb 23.
- Background: PubMed 26992095Lim M, Roosink M, Kim JS, Kim HW, Lee EB, Son KM, Kim HA, Chung CK. Augmented Pain Processing in Primary and Secondary Somatosensory Cortex in Fibromyalgia: A Magnetoencephalography Study Using Intra-Epidermal Electrical Stimulation. PLoS One. 2016 Mar 18;11(3):e0151776. doi: 10.1371/journal.pone.0151776. eCollection 2016.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be made available on the 'Open Science Framework' after undergoing the process of anonymization to remove any participant-identifying information. The data will consist of the raw EEG signals and raw behavioral responses to cognitive tasks. Additionally, the statistical analysis and Jupyter notebooks used to process the data will also be shared
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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.
Biurrun Manresa principal investigator
National Council of Scientific and Technical Research, Argentina (CONICET)
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 National Council of Scientific and Technical Research, Argentina at 1 site in Argentina.
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 11 inclusion and 11 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 14 Aug 2025. 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 Argentina. 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?
Percentual Habituation (time frame: Immediately after the intervention). 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 NCT06905171, which also lists 10 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 14 Aug 2025.