Back to resultsPain in Adults With Autism Spectrum Disorder (DOUPA)
Primary Purpose
Autism, Pain
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
thermode
Sponsored by
About this trial
This is an interventional diagnostic trial for Autism focused on measuring high functioning autism, endogenous modulation systems
Eligibility 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
Sites / Locations
- CHRU Brest
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
high functioning Autism
witness
Arm 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
Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with a witness
Outcomes
Primary Outcome Measures
Pain as assessed by Computerized Visual analog scale
Secondary Outcome Measures
salivary cortisol
Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale
heart rate variability
Full Information
NCT ID
NCT02277756
First Posted
October 21, 2014
Last Updated
October 11, 2017
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT02277756
Brief Title
Pain in Adults With Autism Spectrum Disorder
Acronym
DOUPA
Official Title
Pain Neuromodulation in Adults With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
autistic recruitment problems
Study Start Date
May 29, 2015 (Actual)
Primary Completion Date
April 5, 2017 (Actual)
Study Completion Date
April 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Pain
Keywords
high functioning autism, endogenous modulation systems
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high functioning Autism
Arm Type
Experimental
Arm 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
Arm Title
witness
Arm Type
Placebo Comparator
Arm Description
Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with a witness
Intervention Type
Device
Intervention Name(s)
thermode
Intervention Description
thermal stimulation with test thermode
Primary Outcome Measure Information:
Title
Pain as assessed by Computerized Visual analog scale
Time Frame
one day
Secondary Outcome Measure Information:
Title
salivary cortisol
Time Frame
one day
Title
Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale
Time Frame
one day
Title
heart rate variability
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gildas L'HEVEDER, Doctor
Organizational Affiliation
CHRU Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Brest
City
Brest
Country
France
12. IPD Sharing Statement
Learn more about this trial
Pain in Adults With Autism Spectrum Disorder
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