Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT04364568
Status:
TERMINATED
Last Update Posted:
2024-05-28
First Post:
2020-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'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': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D007406', 'term': 'Interview, Psychological'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011580', 'term': 'Psychological Techniques'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, monocentric, etiological cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'difficulty recruiting and no sociologists', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2020-03-20', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the mean lesion volume fraction found in multiparametric magnetic resonance imaging between patients with and without post-concussions syndrome, three months after a mild Traumatic Brain Injury.', 'timeFrame': '3 months', 'description': 'Mean of cerebral volume fraction corresponding to lesions areas, found in multiparametrical magnetic resonance imaging (expressed as a percentage), 3 months after mild traumatic brain injury.'}], 'secondaryOutcomes': [{'measure': 'Describe correlation between anamnestic risk factors, demographic data and post-concussion syndrome occurence', 'timeFrame': '3 months', 'description': 'Describe correlation between risk factor and the development of post-concussion syndrome.\n\nDescribe risk factors as demographic factors and medical history correlated with the development of post-concussion syndrome.\n\nThe risk factors studies will be:\n\n* Age (median in years)\n* Sex\n* Cohabitation status\n* Education\n* Daily consumption of alcohol\n* Smoking\n* Glasgow score\n* Loss of consciousness after the trauma\n* Associated injuries This information will be obtained using the medical record and by interviewing the patient. The presence of post-concussion syndrome will be defined using the Rivermead Post-concussion Symptoms Questionnaire. The presence of post-concussion syndrome will correspond to a score higher than 12.'}, {'measure': 'Level of asymmetry of the signal between each hemisphere, for each magnetic resonance imagings equence, and with the techniques of ROI (Regions of Interests): asymmetry threshold corresponding to a lesion.', 'timeFrame': '3 months', 'description': 'Measuring the level of asymmetry of the signal between each hemisphere, for each magnetic resonance imaging sequence, and with the techniques of ROI (Regions of Interests) ;to determine the asymmetry threshold corresponding to a lesion.'}, {'measure': 'Graph metrics in resting-state functional magnetic resonance imaging in both groups', 'timeFrame': '3 months', 'description': 'Describe the graph metrics in resting-state functional MRI in both groups'}, {'measure': 'Clinical correlation of magnetic resonance imaging with symptoms.', 'timeFrame': '3 months', 'description': 'Look for a clinical correlation between psychological evaluation tests and magnetic resonance imaging observations such as damages zones.'}, {'measure': 'Describe in both groups, the evolution of symptomatology at one year', 'timeFrame': '12 months', 'description': 'Describe in both groups, the evolution of symptomatology at one year with the Rivermead Post-Concussion Syndrome Questionnaire (RPCSQ). The Rivermead questionnaire ranges from 0 to 64. The presence of post-concussion syndrome will correspond to a score higher than 12.'}, {'measure': "Evaluate the impact of mTBI on patients' lifestyles", 'timeFrame': '6 months', 'description': "Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion."}, {'measure': "Evaluate the impact of mTBI on patients' lifestyles", 'timeFrame': '12 months', 'description': "Sociologic interview to understand the impact of mTBI on patients' lifestyles and social insertion."}, {'measure': 'Evaluate the impact of social characteristics at stake and the resources mobilized', 'timeFrame': '6 months', 'description': "Understand the impact of social characteristics at stake and the resources mobilized in the social life's re-establishment post TBI through a sociologic interview"}, {'measure': 'Evaluate the impact of social characteristics and the resources mobilized', 'timeFrame': '12 months', 'description': "Understand the impact of social characteristics at stake and the resources mobilized in the social life's re-establishment post TBI through a sociologic interview"}, {'measure': "Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.", 'timeFrame': '6 months', 'description': "Sociologic questionnaires to different actors of the patient recovery to understand the experience of mTBI and post-concussion syndrome :\n\n* the patient's personal appreciation,\n* the judgement of family and friends\n* the medical follow-up of the general practitioner."}, {'measure': "Evaluate the experience of mTBI and post-concussion syndrome through the patient's personal appreciation, the judgement of family and friends and the medical follow-up of the general practitioner.", 'timeFrame': '12 months', 'description': "Sociologic questionnaires to different actors of the patient recovery to understand the experience of mTBI and post-concussion syndrome :\n\n* the patient's personal appreciation,\n* the judgement of family and friends\n* the medical follow-up of the general practitioner."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': "Minor traumatic brain injury (mTBI) (Glasgow Coma Scale 13 to 15) represent 70 to 90% of traumatic brain injury. Different disorders may occur after a traumatic minor brain injury (somatic, cognitive or affective) within 2 weeks.\n\nFor 10 to 20% these symptoms are persistent and are part of post-concussion syndrome. Today a small amount of tools to predict this syndrome are available. Cerebral CT scan, a routine test for mTBI, isn't relevant to predict the post concussion syndrome.\n\nIn order to improve understanding of the evolution toward this complication, it seems relevant to run a multimodal study.\n\nMultiparameter MRI combined to psychological and sociological evaluations cold provide a better global perception."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who answered to psychological questionnaires 3 month after mTBI\n* Patients with mTBI according to European Federation of Neurological Societies\n* Initial CT scan indication according to 2012 French Society of Emergency Medicine and European Federation of Neurological Societies\n* Health insurance\n* Written consent\n\nExclusion Criteria:\n\n* Under 18 years\n* Psychiatric or neurologic history with long term treatment\n* Hospitalization due to extra-cranial wounds or intoxication (except alcool)\n* MTBI due to aggression\n* MRI contraindication\n* Inability to understand french language\n* Pregnant or breastfeeding women\n* Incapacitated patients in accordance with article L 1121-5 to L1121-8 of the public health code\n* Patients in another study's exclusion time\n* Inability to have a follow-up\n* Patients who can't be reached in case of emergency"}, 'identificationModule': {'nctId': 'NCT04364568', 'acronym': 'TRACE', 'briefTitle': 'Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion', 'orgStudyIdInfo': {'id': '38RC19.305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Symptomatic group at three month', 'description': 'Rivermead Post-Concussion Syndrome \\>= 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview\n\n1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire', 'interventionNames': ['Radiation: Magnetic Resonance Imaging']}, {'type': 'EXPERIMENTAL', 'label': 'Asymptomatic group at three month', 'description': 'Rivermead Post-Concussion Syndrome \\< 12 MRI and clinical exam and sociological interview at day 105 (+/-15 days) 6 months follow up : sociological interview\n\n1 year follow up : psychological and sociological interview, Rivermead Post Concussion Syndrome questionnaire', 'interventionNames': ['Radiation: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'RADIATION', 'otherNames': ['Sociological interview', 'Psychological interview'], 'description': 'IRM Sequences T1, T2, FLAIR, T2\\*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)', 'armGroupLabels': ['Asymptomatic group at three month', 'Symptomatic group at three month']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38047', 'city': 'Grenoble', 'country': 'France', 'facility': 'Chu Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regional Council of Auvergne-Rhône-Alpes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}