Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-04-09 @ 11:29 AM
Study NCT ID:
NCT02424656
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alterations in the Brain's Connectome After Severe Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}], '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'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-10', 'studyFirstSubmitDate': '2015-04-16', 'studyFirstSubmitQcDate': '2015-04-20', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in whole brain connectivity as a measure of recovery of consciousness', 'timeFrame': 'up to 32 months'}]}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury', 'Disorders of Consciousness']}, 'referencesModule': {'references': [{'pmid': '28615277', 'type': 'BACKGROUND', 'citation': "Conde V, Andreasen SH, Petersen TH, Larsen KB, Madsen K, Andersen KW, Akopian I, Madsen KH, Hansen CP, Poulsen I, Kammersgaard LP, Siebner HR. Alterations in the brain's connectome during recovery from severe traumatic brain injury: protocol for a longitudinal prospective study. BMJ Open. 2017 Jun 14;7(6):e016286. doi: 10.1136/bmjopen-2017-016286."}, {'pmid': '31588844', 'type': 'RESULT', 'citation': 'Andreasen SH, Andersen KW, Conde V, Dyrby TB, Puonti O, Kammersgaard LP, Madsen CG, Madsen KH, Poulsen I, Siebner HR. Limited Colocalization of Microbleeds and Microstructural Changes after Severe Traumatic Brain Injury. J Neurotrauma. 2020 Feb 15;37(4):581-592. doi: 10.1089/neu.2019.6608. Epub 2019 Nov 20.'}, {'pmid': '33013616', 'type': 'RESULT', 'citation': 'Andreasen SH, Andersen KW, Conde V, Dyrby TB, Puonti O, Kammersgaard LP, Madsen CG, Madsen KH, Poulsen I, Siebner HR. Two Coarse Spatial Patterns of Altered Brain Microstructure Predict Post-traumatic Amnesia in the Subacute Stage of Severe Traumatic Brain Injury. Front Neurol. 2020 Sep 4;11:800. doi: 10.3389/fneur.2020.00800. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This study explores the changes in whole-brain connectivity that occur during recovery from severe Traumatic Brain Injury and how these changes are related to the recovery of consciousness. Multimodal neuroimaging techniques will be used in a longitudinal fashion while patients are undergoing neurorehabilitation and after one-year of the TBI episode.', 'detailedDescription': 'Severe Traumatic Brain Injury (TBI) can result in a long-lasting altered state of consciousness. At present, the underlying neurological determinants of recovery in patients with disorders of consciousness (DOC) after a severe TBI are not well understood, and individual prognosis is very limited. Moreover, the rate of misdiagnosis between different states of altered consciousness by standard clinical scales is high, which further impacts on the clinical prognosis. In this project, multimodal neuroimaging measures will be applied and whole-brain data will be obtained from patients recovering from severe TBI in a longitudinal fashion. Patients will be examined at four time points during the sub-acute stage: immediately after admission to the neurorehabilitation unit, after ten weeks of admission, at discharge, and after one year of the TBI episode. Brain connectivity will be assessed with functional Magnetic Resonance Imaging (fMRI) combined with electroencephalography (EEG), structural MRI, diffusion MRI, high-density EEG (hdEEG) alone, and hdEEG combined with Transcranial Magnetic Stimulation (EEG-TMS), and \\[18F\\]-fluorodeoxyglucose positron emission tomography (FDG-PET).\n\nThe overall aim of the study is to find reliable biomarkers for the recovery of consciousness based on changes in cortico-cortical and cortico-subcortical brain connectivity. In order to explore this, patients that suffered a severe TBI as well a matched healthy participants group will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. 30 Patients that have suffered a close-head TBI with associated DOC and that are admitted to neurorehabilitation at the TBI unit of Glostrup Hospital.\n2. 20 Healthy participants without history of neurological disorders, age-, gender-, and socioeconomically-matched to the included patients.', 'healthyVolunteers': True, 'eligibilityCriteria': "Patient's inclusion criteria:\n\n\\- closed-head injury\n\nPatient's exclusion criteria:\n\n* high level of consciousness after coma\n* ventricular shunt for hydrocephalus\n* large intracerebral hemorrhages or infarctions\n* structural lesions in the brain stem\n* locked-in syndrome due to motor pathway lesions\n* contraindications for MR\n* contraindications for TMS\n\nHealthy participant's inclusion criteria:\n\n\\- no prior history of neurological disorders and / or head injury\n\nHealthy participant's exclusion criteria:\n\n* contraindications for MR\n* contraindications for TMS"}, 'identificationModule': {'nctId': 'NCT02424656', 'acronym': 'ABCinTBI', 'briefTitle': "Alterations in the Brain's Connectome After Severe Traumatic Brain Injury", 'organization': {'class': 'OTHER', 'fullName': 'Danish Research Centre for Magnetic Resonance'}, 'officialTitle': "Alterations in the Brain's Connectome in Severe Traumatic Brain Injury", 'orgStudyIdInfo': {'id': 'H-4-2013-186'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with TBI and DOC.\n\nExperimental measures (MRI, TMS-EEG, and clinical scales) will be performed at 4 time points: within 2 weeks of admission, 6-10 weeks after admission, at discharge, 1-year follow-up after TBI episode. FDG-PET will be performed in a subset of 25 patients at 3 time points: at admission, at discharge, and at 1-year follow-up.', 'interventionNames': ['Procedure: MRI', 'Procedure: TMS-EEG', 'Procedure: FDG-PET', 'Other: Clinical scales']}, {'label': '2', 'description': 'Healthy patient-matched controls.\n\nExperimental measures (MRI, TMS-EEG, and FDG-PET) will be performed at 2 time points: within patient admission, and within patient discharge.', 'interventionNames': ['Procedure: MRI', 'Procedure: TMS-EEG', 'Procedure: FDG-PET']}], 'interventions': [{'name': 'MRI', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance Imaging'], 'description': 'EEG-functional MRI, structural MRI, diffusion MRI', 'armGroupLabels': ['1', '2']}, {'name': 'TMS-EEG', 'type': 'PROCEDURE', 'otherNames': ['Transcranial Magnetic Stimulation-Electroencephalogram'], 'description': 'Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation', 'armGroupLabels': ['1', '2']}, {'name': 'FDG-PET', 'type': 'PROCEDURE', 'otherNames': ['[18F]-fluorodeoxyglucose positron emission tomography'], 'armGroupLabels': ['1', '2']}, {'name': 'Clinical scales', 'type': 'OTHER', 'description': 'Evaluation of DOC: Coma recovery scale-Revised (CRS-R) and Rancho Los Amigos Scale (RLAS). Evaluation of function: Functional Independent Measure (FIMTM), and Early Functional Assessment (EFA).', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Danish Research Centre for Magnetic Resonance', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Research Centre for Magnetic Resonance', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Milan', 'class': 'OTHER'}, {'name': 'University of Kiel', 'class': 'OTHER'}, {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, {'name': 'Lundbeck Foundation', 'class': 'OTHER'}, {'name': 'Danish Council for Independent Research', 'class': 'OTHER'}, {'name': 'Region Capital Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of research', 'investigatorFullName': 'Hartwig R. Siebner', 'investigatorAffiliation': 'Danish Research Centre for Magnetic Resonance'}}}}