Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-15 @ 4:12 AM
Study NCT ID:
NCT01947504
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2013-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Intervention Following Mild TBI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2013-09-17', 'studyFirstSubmitQcDate': '2013-09-17', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of post-concussive symptoms', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mild Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '33656475', 'type': 'DERIVED', 'citation': 'Audrit H, Beauchamp MH, Tinawi S, Lague-Beauvais M, Saluja R, de Guise E. Multidimensional Psychoeducative and Counseling Intervention (SAAM) for Symptomatic Patients With Mild Traumatic Brain Injury: A Pilot Randomized Controlled Trial. J Head Trauma Rehabil. 2021 Jul-Aug 01;36(4):E249-E261. doi: 10.1097/HTR.0000000000000653.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to implement and measure the efficiency of a standardized acute and brief non-pharmacological intervention (Cognitive interventions on Sleep - Anxiety - Attention - Memory) following mild TBI and observe their impact pre- and post-treatments. The ultimate goal is to have patients be re-integrated to their activities faster with lesser symptoms and have patients present lesser post-concussive symptoms. Specific objectives: 1) Measure the effect of an acute and brief non-pharmacological intervention on PCS symptoms, sleep, headaches, affect, cognition and functional outcome following mild TBI; 2)To redefine a model of outcome prediction following mild TBI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Mild TBI\n\nExclusion Criteria:\n\n* Psychiatric diagnosis'}, 'identificationModule': {'nctId': 'NCT01947504', 'briefTitle': 'Early Intervention Following Mild TBI', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Acute and Brief Intervention Following Mild Traumatic Brain Injury: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '3525'}, 'secondaryIdInfos': [{'id': 'MUHC', 'type': 'OTHER', 'domain': 'MUHC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'education and support intervention', 'description': 'education and support intervention', 'interventionNames': ['Behavioral: education and support intervention']}, {'type': 'NO_INTERVENTION', 'label': 'waiting list', 'description': 'waiting list and regular medical follow-up'}], 'interventions': [{'name': 'education and support intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['education and support intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Center', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elaine De Guise', 'class': 'OTHER'}, 'collaborators': [{'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Elaine De Guise', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}