Habituation of Brain Responses to Sensory Stimuli in Fibromyalgia

NCT06905171 | Completed

• 1 other identifier: IS004760
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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 hypersensitivity? Participants will: \- receive randomized sensory stimuli (auditory, visual, somatosensory, audiovisual, auditory-somatosensory, visual-somatosensory, and auditory-visual-somatosensory) in blocks of 20 trials.

Conditions

Fibromyalgia

Keywords

Event-Related Potentials; Electroencephalography; Habituation

Outcome Measures

Primary Outcomes (1)

• Percentual Habituation

  Relative reduction in the amplitude of evoked potentials between consecutive stimuli

  Immediately after the intervention

Secondary Outcomes (9)

• Fibromyalgia Impact Questionnaire-Revised version (FIQR)

  10 minutes before the intervention

• Symptoms Impact Questionnaire (SIQ)

  10 minutes before the intervention

• Hospital Anxiety and Depression Scale (HADS)

  10 minutes before the intervention

• Numeric Rating Scale Pain (NRSp)

  10 minutes before the intervention

• Stimulus saliency

  Immediately after the intervention

Study Arms (2)

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.

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

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

Interventions

Auditory Stimulation OTHER

A tone at a 1000 Hz frequency, delivered through speakers at a comfortable volume

Fibromyalgia Patients; Healthy Controls

Visual Stimulation OTHER

A checkerboard pattern displayed on a monitor, with colors alternating every 25 ms

Fibromyalgia Patients; Healthy Controls

Somatosensory Stimulation OTHER

A train of three electrical stimuli, each lasting 1 ms, separated by 8 ms, at an intensity that clearly elicits a pricking sensation

Fibromyalgia Patients; Healthy Controls

Auditory-Visual Stimulation OTHER

Stimulation using auditory and visual stimuli concomitantly

Fibromyalgia Patients; Healthy Controls

Visual-Somatosensory Stimulation OTHER

Stimulation using visual and somatosensory stimuli concomitantly

Fibromyalgia Patients; Healthy Controls

Auditory-Somatonsensory Stimulation OTHER

Stimulation using auditory and somatosensory stimuli concomitantly

Fibromyalgia Patients; Healthy Controls

Auditory-Visual-Somatosensory Stimulation OTHER

Stimulation using auditory, visual and somatosensory stimuli concomitantly

Fibromyalgia Patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• National Council of Scientific and Technical Research, Argentina: lead

Study Sites (1)

Faculty of Engineering-National University of Entre Ríos

Oro Verde, Entre Ríos Province, 3100, Argentina

Location

Related Publications (10)

• 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.

  PMID: 16427613 BACKGROUND

• 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.

  PMID: 5324565 BACKGROUND

• 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.

  PMID: 16732548 BACKGROUND

• 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.

  PMID: 10025076 BACKGROUND

• 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.

  PMID: 20685171 BACKGROUND

• 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.

  PMID: 14986061 BACKGROUND

• 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.

  PMID: 8880834 BACKGROUND

• 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.

  PMID: 35983754 BACKGROUND

• 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.

  PMID: 33636370 BACKGROUND

• 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.

  PMID: 26992095 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Substance-Related Disorders

Interventions

Acoustic Stimulation; Photic Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Study Officials

• Biurrun Manresa

  National Council of Scientific and Technical Research, Argentina (CONICET)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: March 14, 2025
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The participant's data and the processing pipeline will be available after the data collection is finished. The supporting information (including the study protocol, the statistical analysis plan and the informed consent) will be uploaded as soon as possible.
• Access Criteria: The data will be publicly available.

Locations

AR (1)