Habituation of Brain Responses to Sensory Stimuli in Fibromyalgia
NCT ID: NCT06905171
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
26 participants
OBSERVATIONAL
2025-03-14
2025-05-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Investigation of the Relationship Between Sensory Processing and Kinesychophobia in Fibromyalgia Patients
NCT03746379
Effects of a Motor Imagery Exercise Protocol in Patients With Fibromyalgia
NCT03870932
Pain Neuroscience Education, Conditioned Pain Modulation and Emotional Processes in Fibromyalgia
NCT07055971
Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia
NCT03785535
Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia
NCT03801109
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Auditory Stimulation
A tone at a 1000 Hz frequency, delivered through speakers at a comfortable volume
Visual Stimulation
A checkerboard pattern displayed on a monitor, with colors alternating every 25 ms
Somatosensory Stimulation
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 Stimulation
Stimulation using auditory and visual stimuli concomitantly
Visual-Somatosensory Stimulation
Stimulation using visual and somatosensory stimuli concomitantly
Auditory-Somatonsensory Stimulation
Stimulation using auditory and somatosensory stimuli concomitantly
Auditory-Visual-Somatosensory Stimulation
Stimulation using auditory, visual and somatosensory stimuli concomitantly
Healthy Controls
Volunteers with no clinical history of chronic pain, musculoskeletal or articular disorders
Auditory Stimulation
A tone at a 1000 Hz frequency, delivered through speakers at a comfortable volume
Visual Stimulation
A checkerboard pattern displayed on a monitor, with colors alternating every 25 ms
Somatosensory Stimulation
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 Stimulation
Stimulation using auditory and visual stimuli concomitantly
Visual-Somatosensory Stimulation
Stimulation using visual and somatosensory stimuli concomitantly
Auditory-Somatonsensory Stimulation
Stimulation using auditory and somatosensory stimuli concomitantly
Auditory-Visual-Somatosensory Stimulation
Stimulation using auditory, visual and somatosensory stimuli concomitantly
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Auditory Stimulation
A tone at a 1000 Hz frequency, delivered through speakers at a comfortable volume
Visual Stimulation
A checkerboard pattern displayed on a monitor, with colors alternating every 25 ms
Somatosensory Stimulation
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 Stimulation
Stimulation using auditory and visual stimuli concomitantly
Visual-Somatosensory Stimulation
Stimulation using visual and somatosensory stimuli concomitantly
Auditory-Somatonsensory Stimulation
Stimulation using auditory and somatosensory stimuli concomitantly
Auditory-Visual-Somatosensory Stimulation
Stimulation using auditory, visual and somatosensory stimuli concomitantly
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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
Exclusion Criteria
* 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:
* 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
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Council of Scientific and Technical Research, Argentina
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
José Biurrun Manresa
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Biurrun Manresa
Role: PRINCIPAL_INVESTIGATOR
National Council of Scientific and Technical Research, Argentina (CONICET)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Engineering-National University of Entre Ríos
Oro Verde, Entre Ríos Province, Argentina
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Thompson 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.
Montoya 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.
Lorenz 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.
de 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.
Alanoglu 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.
McDermid 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.
Young 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.
Staud 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.
Lim 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IS004760
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.