Study Stopped
autistic recruitment problems
Pain in Adults With Autism Spectrum Disorder
DOUPA
Pain Neuromodulation in Adults With Autism Spectrum Disorder
1 other identifier
interventional
39
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2014
CompletedFirst Posted
Study publicly available on registry
October 29, 2014
CompletedStudy Start
First participant enrolled
May 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2017
CompletedOctober 12, 2017
October 1, 2017
1.9 years
October 21, 2014
October 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain as assessed by Computerized Visual analog scale
one day
Secondary Outcomes (3)
salivary cortisol
one day
Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale
one day
heart rate variability
one day
Study Arms (2)
high functioning Autism
EXPERIMENTALThermal 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
witness
PLACEBO COMPARATORThermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with a witness
Interventions
Eligibility Criteria
You may qualify if:
- intellectual quotient \>85
- consent form signed
- autism diagnosis (CIM 10) from multidisciplinary evaluation (ADI-r, ADOS)
- sibling without autism or developmental disorder
You may not qualify if:
- chronic pain
- pregnancy, breast feeding
- consent form no signed
- \- diagnosis of autism or developmental disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU Brest
Brest, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gildas L'HEVEDER, Doctor
CHRU Brest
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2014
First Posted
October 29, 2014
Study Start
May 29, 2015
Primary Completion
April 5, 2017
Study Completion
April 5, 2017
Last Updated
October 12, 2017
Record last verified: 2017-10