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Completed

NCT Number: NCT06905171

Habituation of Brain Responses to Sensory Stimuli in 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Engineering-National University of Entre Ríos

Oro Verde, Entre Ríos Province, 3100, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory Stimulation

Other

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

Visual stimulation

Other

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

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

Auditory-Visual Stimulation

Other

Stimulation using auditory and visual stimuli concomitantly

Visual-Somatosensory Stimulation

Other

Stimulation using visual and somatosensory stimuli concomitantly

Auditory-Somatonsensory Stimulation

Other

Stimulation using auditory and somatosensory stimuli concomitantly

Auditory-Visual-Somatosensory Stimulation

Other

Stimulation using auditory, visual and somatosensory stimuli concomitantly

Primary outcomes

  1. Percentual Habituation

    Time frame: Immediately after the intervention

    Relative reduction in the amplitude of evoked potentials between consecutive stimuli

Secondary outcomes

  1. Fibromyalgia Impact Questionnaire-Revised version (FIQR)

    Time frame: 10 minutes before the intervention

    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

  2. Symptoms Impact Questionnaire (SIQ)

    Time frame: 10 minutes before the intervention

    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

  3. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 10 minutes before the intervention

    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.

  4. Numeric Rating Scale Pain (NRSp)

    Time frame: 10 minutes before the intervention

    Pain at the moment of the experimental session. Scores range from 0 to 10, with higher number indicating worse pain.

  5. Stimulus saliency

    Time frame: Immediately after the intervention

    A number reflecting the ability of a stimulus to stand out relative to the sensory background or relative to the preceding stimuli

  6. Event-related potentials amplitude

    Time frame: Immediately after the intervention

    Amplitude, in microvolts, of event-related brain potentials

  7. Event-related potentials latency

    Time frame: Immediately after the intervention

    Latency, in milliseconds, of event-related brain potentials

  8. Non-specific components amplitude

    Time frame: Immediately after the intervention

    Amplitude, in microvolts, of the non/specific component derived from the ERPs

  9. Non-specific components latency

    Time frame: Immediately after the intervention

    Latency, in milliseconds, of the non-specific component derived from the ERPs

Sponsors and collaborators

Lead sponsor

National Council of Scientific and Technical Research, Argentina

Other Gov

Registry information

Official study title

Analysis of Brain Responses and Habituation to Multimodal Sensory Stimuli in Patients With Fibromyalgia

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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