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Pain in Adults With Autism Spectrum Disorder (DOUPA)

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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

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE October 29, 2014
Last Update Posted Date October 12, 2017
Actual Study Start Date  ICMJE May 29, 2015
Actual Primary Completion Date April 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2015)
Pain as assessed by Computerized Visual analog scale [ Time Frame: one day ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
Pain as assessed by Visual analog scale [ Time Frame: one day ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • salivary cortisol [ Time Frame: one day ]
  • Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale [ Time Frame: one day ]
  • heart rate variability [ Time Frame: one day ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain in Adults With Autism Spectrum Disorder
Official Title  ICMJE Pain Neuromodulation in Adults With Autism Spectrum Disorder
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Autism
  • Pain
Intervention  ICMJE Device: thermode
thermal stimulation with test thermode
Study Arms  ICMJE
  • 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
    Intervention: Device: 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
    Intervention: Device: thermode
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 13, 2017)
39
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2014)
90
Actual Study Completion Date  ICMJE April 5, 2017
Actual Primary Completion Date April 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02277756
Other Study ID Numbers  ICMJE DOUPA (RB 14.035)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Brest
Study Sponsor  ICMJE University Hospital, Brest
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gildas L'HEVEDER, Doctor CHRU Brest
PRS Account University Hospital, Brest
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP