Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 12:16 PM
Study NCT ID:
NCT02277756
Status:
TERMINATED
Last Update Posted:
2017-10-12
First Post:
2014-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain in Adults With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'autistic recruitment problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2014-10-21', 'studyFirstSubmitQcDate': '2014-10-27', 'lastUpdatePostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain as assessed by Computerized Visual analog scale', 'timeFrame': 'one day'}], 'secondaryOutcomes': [{'measure': 'salivary cortisol', 'timeFrame': 'one day'}, {'measure': 'Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale', 'timeFrame': 'one day'}, {'measure': 'heart rate variability', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['high functioning autism', 'endogenous modulation systems'], 'conditions': ['Autism', 'Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Adults with autism without intellectual disability (IQ \\> 85) are matched with members of siblings and control group (sex and chronological age).\n\nPain 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.\n\nDemographic and clinical data are also collected (sensory profile, sleep disorders and depression inventory).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Non-specific inclusion criteria:\n\n* intellectual quotient \\>85\n* consent form signed\n\nInclusion Criteria autism group :\n\n* autism diagnosis (CIM 10) from multidisciplinary evaluation (ADI-r, ADOS)\n* sibling without autism or developmental disorder\n\nNon-specific Exclusion Criteria:\n\n* chronic pain\n* pregnancy, breast feeding\n* consent form no signed\n\nExclusion criteria sibling and witness groups:\n\n\\- diagnosis of autism or developmental disorder'}, 'identificationModule': {'nctId': 'NCT02277756', 'acronym': 'DOUPA', 'briefTitle': 'Pain in Adults With Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Pain Neuromodulation in Adults With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'DOUPA (RB 14.035)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high functioning Autism', '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', 'interventionNames': ['Device: thermode']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'witness', 'description': 'Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with a witness', 'interventionNames': ['Device: thermode']}], 'interventions': [{'name': 'thermode', 'type': 'DEVICE', 'description': 'thermal stimulation with test thermode', 'armGroupLabels': ['high functioning Autism', 'witness']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brest', 'country': 'France', 'facility': 'CHRU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'overallOfficials': [{'name': "Gildas L'HEVEDER, Doctor", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}