Pain in Adults With Autism Spectrum Disorder

NCT ID: NCT02277756

Last Updated: 2017-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-29

Study Completion Date

2017-04-05

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Autism Pain

Keywords

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high functioning autism endogenous modulation systems

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

thermode

Intervention Type DEVICE

thermal stimulation with test thermode

witness

Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with a witness

Group Type PLACEBO_COMPARATOR

thermode

Intervention Type DEVICE

thermal stimulation with test thermode

Interventions

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thermode

thermal stimulation with test thermode

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* intellectual quotient \>85
* consent form signed


* autism diagnosis (CIM 10) from multidisciplinary evaluation (ADI-r, ADOS)
* sibling without autism or developmental disorder

Exclusion Criteria

* chronic pain
* pregnancy, breast feeding
* consent form no signed


\- diagnosis of autism or developmental disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gildas L'HEVEDER, Doctor

Role: PRINCIPAL_INVESTIGATOR

CHRU Brest

Locations

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CHRU Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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DOUPA (RB 14.035)

Identifier Type: -

Identifier Source: org_study_id