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Habituation of Brain Responses to Sensory Stimuli in Fibromyalgia

N

National Scientific and Technological Research Council (CONICET)

Status

Completed

Conditions

Fibromyalgia

Treatments

Other: Visual Stimulation
Other: Visual-Somatosensory Stimulation
Other: Auditory-Somatonsensory Stimulation
Other: Somatosensory Stimulation
Other: Auditory-Visual-Somatosensory Stimulation
Other: Auditory Stimulation
Other: Auditory-Visual Stimulation

Study type

Observational

Funder types

Other

Identifiers

NCT06905171
IS004760

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

26 participants in 2 patient groups

Fibromyalgia Patients
Description:
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.
Treatment:
Other: Auditory-Visual Stimulation
Other: Auditory Stimulation
Other: Auditory-Visual-Somatosensory Stimulation
Other: Somatosensory Stimulation
Other: Auditory-Somatonsensory Stimulation
Other: Visual-Somatosensory Stimulation
Other: Visual Stimulation
Healthy Controls
Description:
Volunteers with no clinical history of chronic pain, musculoskeletal or articular disorders
Treatment:
Other: Auditory-Visual Stimulation
Other: Auditory Stimulation
Other: Auditory-Visual-Somatosensory Stimulation
Other: Somatosensory Stimulation
Other: Auditory-Somatonsensory Stimulation
Other: Visual-Somatosensory Stimulation
Other: Visual Stimulation

Trial contacts and locations

1

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Central trial contact

Elizabeth L Young, Bioing; José A Biurrun Manresa, PhD

Data sourced from clinicaltrials.gov

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