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Pain in Adults With Autism Spectrum Disorder (DOUPA)

R

Regional University Hospital Center (CHRU)

Status

Terminated

Conditions

Pain
Autism

Treatments

Device: thermode

Study type

Interventional

Funder types

Other

Identifiers

NCT02277756
DOUPA (RB 14.035)

Details and patient eligibility

About

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 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).

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

39 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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