Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain in Adults With Autism Spectrum Disorder (DOUPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277756
Recruitment Status : Terminated (autistic recruitment problems)
First Posted : October 29, 2014
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Autism Pain Device: thermode Not Applicable

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).

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pain Neuromodulation in Adults With Autism Spectrum Disorder
Actual Study Start Date : May 29, 2015
Actual Primary Completion Date : April 5, 2017
Actual Study Completion Date : April 5, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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
 Device: thermode
thermal stimulation with test thermode
Placebo Comparator: witness
Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with a witness
 Device: thermode
thermal stimulation with test thermode


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Pain as assessed by Computerized Visual analog scale [ Time Frame: one day ]

Secondary Outcome Measures :
  1. salivary cortisol [ Time Frame: one day ]
  2. Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale [ Time Frame: one day ]
  3. heart rate variability [ Time Frame: one day ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277756


Locations
Layout table for location information
France
CHRU Brest
Brest, France
Sponsors and Collaborators
University Hospital, Brest
Investigators
Layout table for investigator information
Principal Investigator: Gildas L'HEVEDER, Doctor CHRU Brest
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02277756    
Other Study ID Numbers: DOUPA (RB 14.035)
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Keywords provided by University Hospital, Brest:
high functioning autism
endogenous modulation systems
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders