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Recruiting Observational

Quantitative Sensory Testing to Study Pain Perception in Autism

NCT06659731 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-07-17
Last updated
2024-10-26

Condition(s) studied

Autism Spectrum Disorder (ASD)Pain Perception

Investigational drug(s) / intervention(s)

Quantitative Sensory testing (QST)EEG

Quantitative Sensory testing (QST): The QST protocol (Rolke et al., 2006; Blankenburg et al., 2010), implies the administration of 7 short sensory test in order to measure up to 13 parameters, which can be grouped as follows: thermal detection thresholds for the perception of cold, warm and paradoxical heat sensations, thermal pain thresholds for cold and hot stimuli, mechanical detection thresholds for touch and vibration, mechanical pain thresholds and sensitivity for pinprick and blunt pressure, vibration detection threshold and pressure pain threshold.

EEG: EEG recording at rest and while receiving heat stimuli to study cortical processing of salient thermal stimuli. Up to 30 painful thermal stimuli, will be delivered to the patients' hand dorsum in order to register contact heat evoked potentials (CHEPs).

Study summary

This study aims at assess sensory perception, and pain perception, in neurodivergent children and adolescent in the autism spectrum. To achieve this goal, the quantitive sensory testing (QST), a controlled and replicable protocol, will be used, to assess perception in different sensory modalities: heat sensations, mechanical detection threshold and pain threshold. As secondary aim, the cortical processing of thermal painful stimuli will be collected through electroencephalography (EEG) in order to investigate if there are differences in the cortical processing of painful stimuli between clinical sample and control sample, and if it could be associated with differences in the subjective experience between the two groups. Finally, it will be explored the association between such differences, and indexes of psychopathology and dispositional measures.

Eligibility

Sex
ALL
Min age
5 Years
Max age
17 Years
Healthy volunteers
Accepted
Inclusion Criteria for the clinical sample: * Children and adolescent * age between 5 and 17 years old * Autism diagnosis according to DSM-V criteria Inclusion Criteria for the control sample: * healthy children and adolescent (without neurological, and psychiatric, diagnoses) * age between 5 and 17 years old Exclusion Criteria: Comorbidities with (for the clinical sample) or diagnosis of (for the control sample): * peripheral neuropaties; * psychiatric diagnosis as psychosis, * Tourette Syndrome, * neurological diagnoses as epilepsy, * sensory deficit or loss; * genetic diseases

Primary outcome measure(s)

  • EEG responses in the time domain — from the enrollment to the end of EEG recordin (approx. 3 days)
    ERPs amplitude (μV)
  • Cold detection threshold — from the enrollment to the end of QST administration (approx. 2 days)
    The minimum intensity value (°C) at which a cold stimulus is perceived by each participant
  • Warm detection threshold — from the enrollment to the end of QST administration (approx. 2 days)
    The minimum intensity value (°C) at which a warm stimulus is perceived by each participant
  • Cold pain threshold — from the enrollment to the end of QST administration (approx. 2 days)
    The minimum intensity value (°C) at which a cold stimulus is perceived as painful by each participant
  • Warm pain threshold — from the enrollment to the end of QST administration (approx. 2 days)
    The minimum intensity value (°C) at which a warm stimulus is perceived as painful by each participant
  • Mechanical detection threshold — from the enrollment to the end of QST administration (approx. 2 days)
    The minimum intensity value (mN) at which a mechanical stimulus is perceived by each participant. It is a measure of touch perception
  • Mechanical pain threshold — from the enrollment to the end of QST administration (approx. 2 days)
    The minimum intensity value (mN) at which a mechanical stimulus is perceived as painful by each participant.
  • Vibration detection threshold — from the enrollment to the end of QST administration (approx. 2 days)
    The minimum intensity value (Hz) at which a vibratory stimulus is perceived by each participant.
  • Pressure pain threshold — from the enrollment to the end of QST administration (approx. 2 days)
    The minimum intensity value (N) at which a pressure stimulus is perceived as painful by each participant.
  • EEG responses in the time-frequency domain — from the enrollment to the end of QST administration (approx. 3 days)
    Power-spectrum of eeg responses

Trial sites (1)

FacilityCityRegionStatus
IRCCS "E. Medea" Brindisi BR Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06659731 on ClinicalTrials.gov ↗ ← All trials in Italy