Pain in Adults With Autism Spectrum Disorder

Pain Clinical Trial

— DOUPA  

Official title:

Pain Neuromodulation in Adults With Autism Spectrum Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02277756
• Other study ID #: DOUPA (RB 14.035)
• Status: Terminated
• Phase: N/A
• First received: October 21, 2014
• Last updated: October 11, 2017
• Start date: May 29, 2015
• Est. completion date: April 5, 2017

Study information

• Verified date: October 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: April 5, 2017
• Est. primary completion date: April 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Pain

Intervention

Device:
• thermode
thermal stimulation with test thermode

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain as assessed by Computerized Visual analog scale		one day
Secondary	salivary cortisol		one day
Secondary	Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale		one day
Secondary	heart rate variability		one day