Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-06-13 @ 10:22 PM
Study NCT ID:
NCT02350894
Status:
COMPLETED
Last Update Posted:
2018-05-24
First Post:
2015-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-22', 'studyFirstSubmitDate': '2015-01-19', 'studyFirstSubmitQcDate': '2015-01-26', 'lastUpdatePostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microstructural changes in the thalamus, corpus callosum and hippocampus between baseline and follow up, as measured by Diffusion kurtosis imaging (DKI)', 'timeFrame': 'Baseline 2-6 month after mTBI with follow up 6 month after', 'description': 'MRI measurement'}], 'secondaryOutcomes': [{'measure': 'Microstructural changes in the thalamus, corpus callosum and hippocampus from baseline to follow up, as measured by Diffusion tensor imaging (DTI)', 'timeFrame': 'Baseline 2-6 month after mTBI with follow up 6 month after', 'description': 'MRI measurement'}, {'measure': 'Change in post-concussion symptoms from baseline to follow up, as measured by Rivermead post-concussion questionnaire (RPQ) and headache (VAS scale)', 'timeFrame': 'Baseline 2-6 month after mTBI with follow up 6 month after', 'description': 'Symptom score'}, {'measure': 'Change in Cognitive performance from baseline to follow up, as measured by executive function, verbal and visual memory, processing speed, working memory, Visuospatial perception and construction', 'timeFrame': 'Baseline 2-6 month after mTBI with follow up 6 month after', 'description': 'Cognitive test battery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Brain Concussion']}, 'referencesModule': {'references': [{'pmid': '33319932', 'type': 'DERIVED', 'citation': 'Trillingsgaard Naess-Schmidt E, Udby Blicher J, Moller Thastum M, Ulrikka Rask C, Wulff Svendsen S, Schroder A, Hogh Tuborgh A, Ostergaard L, Sangill R, Lund T, Norhoj Jespersen S, Roer Pedersen A, Hansen B, Fristed Eskildsen S, Feldbaek Nielsen J. Microstructural changes in the brain after long-term post-concussion symptoms: A randomized trial. J Neurosci Res. 2021 Mar;99(3):872-886. doi: 10.1002/jnr.24773. Epub 2020 Dec 15.'}], 'seeAlsoLinks': [{'url': 'http://funktionellelidelser.dk/', 'label': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital'}, {'url': 'http://cfin.au.dk/', 'label': 'Center of Functionally Integrative Neuroscience, Aarhus University, Aarhus University Hospital'}]}, 'descriptionModule': {'briefSummary': 'This study examines the possible microstructural changes in the brain during recovery after mTBI using diffusion MRI.', 'detailedDescription': 'This study is embedded in a larger randomized controlled trial (RCT) (ClinicalTrials.gov ID: NCT02337101) from which the subjects are recruited and will separately examine the possible microstructural changes in the brain during recovery after mild traumatic brain injury (mTBI) in subjects with ongoing symptoms more than 2 month after mTBI in both groups from the RCT.\n\nSeveral biomarkers and brain areas has been investigated as possible sites of injury after mTBI. The nature of the diffuse chronic post-concussion symptoms (PCS) makes corpus callosum (CC), thalamus (THA) and hippocampus (HIP) interesting because of their central position and connection to widespread motor, sensory and cognitive processes and other brain areas. In most prior studies conventional magnetic resonance imaging (MRI) has failed to detect pathology especially in the chronic phase after mTBI. Diffusional Kurtosis Imaging (DKI) and Diffusional Tensor Imaging (DTI) are more sensitive to microstructural changes and might serve as biomarkers in the brain after mTBI.\n\nWe hypothesized that a change in symptoms (as measured by cognitive performance and self reported symptoms) will correlate with a change in microstructural changes (as measured with DKI) in thalamus, corpus callosum and hippocampus from baseline 2-6 month after mTBI to follow up 6 month after.\n\nSeparate correlations will also be made for both treatment and control group within the cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Mild traumatic brain injury subjects with ongoing symptoms 2-6 months after trauma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri within the last 2-6 months. The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out pure acceleration - deceleration traumas.\n* Age 18 to 30 years at the time of the head trauma.\n* Able to understand, speak and read Danish.\n* Patients with symptoms on at least three items on the Rivermead Post Concussion Symptoms Questionnaire (RPQ) rated as moderate or severe problem. PCS have to be subjectively rated as causing substantial impairment in daily life.\n* Suitable for MRI examination\n\nExclusion Criteria:\n\n* Objective neurological findings from neurological examination and / or acute trauma CT scan, indicating other neurological diseases or brain damage.\n* Previous concussion leading to persistent PCS within the last two years.\n* Severe abuse of alcohol, prescription drugs and / or illegal drugs.\n* Psychiatric morbidity or severe neurological disease that impedes participation in the treatment, i.e. Bipolar Disorder, autism, psychotic disorder (lifetime), multiple sclerosis etc.'}, 'identificationModule': {'nctId': 'NCT02350894', 'briefTitle': 'Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Microstructural Changes in the Brain During Recovery After Mild Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '1-10-72-139-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mTBI subjects', 'description': 'mTBI subjects with ongoing symptoms', 'interventionNames': ['Behavioral: Graded and behavevial theraphy']}], 'interventions': [{'name': 'Graded and behavevial theraphy', 'type': 'BEHAVIORAL', 'description': 'Graded and behavevial theraphy', 'armGroupLabels': ['mTBI subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8450', 'city': 'Hammel', 'country': 'Denmark', 'facility': 'Region Hospital Hammel Neurocenter', 'geoPoint': {'lat': 56.25762, 'lon': 9.86316}}], 'overallOfficials': [{'name': 'Jørgen F Nielsen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hammel Neurocenter - Universitetsklinik for Neurorehabilitering, Aarhus Universi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regionshospitalet Hammel Neurocenter', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}