Faculty of Engineering-National University of Entre Ríos
Oro Verde, Entre Ríos Province, 3100, Argentina
NCT Number: NCT06905171
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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Notify Me18 year–70 year
All sexes
Observational
Oro Verde, Entre Ríos Province, 3100, Argentina
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Fibromyalgia patients:
Healthy controls:
Exclusion criteria
Fibromyalgia patients:
Healthy controls:
A tone at a 1000 Hz frequency, delivered through speakers at a comfortable volume
A checkerboard pattern displayed on a monitor, with colors alternating every 25 ms
A train of three electrical stimuli, each lasting 1 ms, separated by 8 ms, at an intensity that clearly elicits a pricking sensation
Stimulation using auditory and visual stimuli concomitantly
Stimulation using visual and somatosensory stimuli concomitantly
Stimulation using auditory and somatosensory stimuli concomitantly
Stimulation using auditory, visual and somatosensory stimuli concomitantly
Time frame: Immediately after the intervention
Relative reduction in the amplitude of evoked potentials between consecutive stimuli
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
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
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.
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.
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
Time frame: Immediately after the intervention
Amplitude, in microvolts, of event-related brain potentials
Time frame: Immediately after the intervention
Latency, in milliseconds, of event-related brain potentials
Time frame: Immediately after the intervention
Amplitude, in microvolts, of the non/specific component derived from the ERPs
Time frame: Immediately after the intervention
Latency, in milliseconds, of the non-specific component derived from the ERPs
National Council of Scientific and Technical Research, Argentina
Other Gov
Analysis of Brain Responses and Habituation to Multimodal Sensory Stimuli in Patients With Fibromyalgia
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