Pain in Adults With Autism Spectrum Disorder

Overview

Pain insensibility is often described in people with autism. The aim of this study is to test the pain perception in adults with autistic spectrum disorder without intellectual disability. An experimental model of pain is used to measure endogenous modulation systems. Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms. Salivary cortisol and automatic nervous system (heart rate and blood pressure with an electrocardiogram (Brest :system dantec keypoint natus G3 ; Paris: nexfin HD®) are also tested and behavioral response to thermal stimulation assessed by an inspired behavior scale.

Full Title of Study: “Pain Neuromodulation in Adults With Autism Spectrum Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 5, 2017

Detailed Description

Adults with autism without intellectual disability (IQ > 85) are matched with members of siblings and control group (sex and chronological age). Pain reactivity (Visual analog scale,endogenous modulation systems, salivary cortisol, automatic nervous system and behavioral responses to thermal stimulation assessed by an inspired behavior scale.) in adult with autism is tested using an experimental model of pain. Excitatory and inhibitory modulation systems were elicited using a temporal summation test administered before and after activation of the Diffuse Noxious Inhibitory Control (DNIC) by means of a cold-pressor test. Demographic and clinical data are also collected (sensory profile, sleep disorders and depression inventory).

Interventions

  • Device: thermode
    • thermal stimulation with test thermode

Arms, Groups and Cohorts

  • Experimental: high functioning Autism
    • Thermal stimulation with test thermode Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with high functioning Autism
  • Placebo Comparator: witness
    • Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with a witness

Clinical Trial Outcome Measures

Primary Measures

  • Pain as assessed by Computerized Visual analog scale
    • Time Frame: one day

Secondary Measures

  • salivary cortisol
    • Time Frame: one day
  • Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale
    • Time Frame: one day
  • heart rate variability
    • Time Frame: one day

Participating in This Clinical Trial

Non-specific inclusion criteria:

  • intellectual quotient >85 – consent form signed Inclusion Criteria autism group : – autism diagnosis (CIM 10) from multidisciplinary evaluation (ADI-r, ADOS) – sibling without autism or developmental disorder Non-specific Exclusion Criteria:

  • chronic pain – pregnancy, breast feeding – consent form no signed Exclusion criteria sibling and witness groups: – diagnosis of autism or developmental disorder

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Brest
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gildas L’HEVEDER, Doctor, Principal Investigator, CHRU Brest

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