Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05235802
Status:
UNKNOWN
Last Update Posted:
2022-02-11
First Post:
2021-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Follow-up in 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': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D000070627', 'term': 'Chronic Traumatic Encephalopathy'}], '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': 'D020208', 'term': 'Brain Injury, Chronic'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D015170', 'term': 'Cerebrospinal Fluid Pressure'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cerebrospinal fluid, blood (whole blood, serum and plasma).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GOSE vs structural outcome', 'timeFrame': 'Assessed at the chronic time-point (10-15 years after injury).', 'description': 'Glasgow Outcome Score extended (1-8) will be associated alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (affected voxels).'}, {'measure': 'Barthel Index vs structural outcome', 'timeFrame': 'Assessed at the chronic time-point (10-15 years after injury).', 'description': 'Barthel Index (0-100) will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (affected voxels).'}, {'measure': 'Fatigue Severity Scale vs structural outcome', 'timeFrame': 'Assessed at the chronic time-point (10-15 years after injury).', 'description': 'Fatigue Severity Scale (9-63) will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (affected voxels).'}, {'measure': 'MOCA vs structural outcome', 'timeFrame': 'Assessed at the chronic time-point (10-15 years after injury).', 'description': 'Montreal Cognitive Assessment (MoCA) will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (MOCA score vs affected voxels).'}, {'measure': 'SF-36 vs structural outcome', 'timeFrame': 'Assessed at the chronic time-point (10-15 years after injury).', 'description': 'Short-Form 36 will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (SF-36 score vs affected voxels on MRI).'}, {'measure': 'EQ-5D vs structural outcome', 'timeFrame': 'Assessed at the chronic time-point (10-15 years after injury).', 'description': 'Health-related quality of life (EQ-5D) will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (EQ5D score vs affected voxels on MRI).'}, {'measure': 'MADRS vs structural outcome', 'timeFrame': 'Assessed at the chronic time-point (10-15 years after injury).', 'description': 'Montgomery-Åsberg depression rating scale (MADRS) will be associated with alterations at axonal and myelin integrity as assessed by magnetic resonance imaging (MADRS score vs affected voxels).'}, {'measure': 'Structural outcome vs proteomic markers in serum', 'timeFrame': 'Assessed at the chronic time-point (10-15 years after injury).', 'description': 'Alterations at axonal and myelin integrity as assessed by magnetic resonance imaging will be associated with a proteomic profiling using a targeted antibody array of about 30 proteins of inflammatory and neurodegenerative origin (affected voxels vs mean fluorescent intensities (MFI)).'}, {'measure': 'Structural outcome vs proteomic markers in cerebrospinal fluid', 'timeFrame': 'Assessed at the chronic time-point (10-15 years after injury).', 'description': 'Alterations at axonal and myelin integrity as assessed by magnetic resonance imaging will be associated with a proteomic profiling of cerebrospinal fluid using a targeted antibody array of about 30 proteins of inflammatory and neurodegenerative origin (affected voxels vs mean fluorescent intensities (MFI)).'}, {'measure': 'Structural outcome vs auto-antibodies in serum', 'timeFrame': 'Assessed at the chronic time-point (10-15 years after injury).', 'description': 'Alterations at axonal and myelin integrity as assessed by magnetic resonance imaging will be associated with a panel of auto-antibodies targeting central nervous system antigens ((affected voxels vs antibody titers)'}], 'secondaryOutcomes': [{'measure': 'Acute vs chronic comparisons of proteomic markers in serum', 'timeFrame': 'From samples acquired in the acute phase (first weeks after injury) with samples acquired in the chronic phase (10-15 years after injury)', 'description': 'Proteomic profiling using a targeted antibody array of about 30 proteins of inflammatory and neurodegenerative origin will be compared in a subset of patients between the acute and chronic stage comparing mean flourescent intensities (MFI).'}, {'measure': 'Acute vs chronic comparisons of proteomic markers in CSF', 'timeFrame': 'From samples acquired in the acute phase (first weeks after injury) with samples acquired in the chronic phase (10-15 years after injury)', 'description': 'Proteomic profiling using a targeted antibody array of about 30 proteins of inflammatory and neurodegenerative origin in CSF will be compared in a subset of patients between the acute and chronic stage comparing mean flourescent intensities (MFI).'}, {'measure': 'Acute vs chronic comparisons of autoantibodies', 'timeFrame': 'From samples acquired in the acute phase (first weeks after injury) with samples acquired in the chronic phase (10-15 years after injury)', 'description': 'A panel of auto-antibodies targeting central nervous system antigens will be compared between the acute and chronic phase (comparison of antibody titers)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fluid biomarkers', 'Neuroinflammatory process', 'Auto-immunity', 'Structural imaging', 'Clinical assessment', 'Long-term follow-up'], 'conditions': ['Traumatic Brain Injury', 'Neurodegenerative Diseases', 'Chronic Traumatic Encephalopathy']}, 'descriptionModule': {'briefSummary': "The underlying pathophysiology following traumatic brain injury (TBI) in how different neurodegenerative conditions are developed are still unknown. Different neuroinflammatory and neurodegenerative pathways have been suggested.\n\nThe goal of this study is to follow-up patients that have been treated for TBI at the neurosurgical department about 10-15 years after their initial injury, in order to analyze fluid biomarkers of inflammation, injury and degeneration and associate these with structural imaging and long-term functional outcome.\n\nThe investigators aim to invite about 100 patients back and perform advanced magnetic resonance imaging protocols, sample cerebrospinal fluid and blood for different bio- and inflammatory markers, study genetic modifications and associate it with outcomes being assessed through questionnaires.\n\nThe investigators' hypothesis is that patients with ongoing inflammatory processes will present with more fluid biomarkers of neurodegeneration, worse clinical presentation and also more structural/atrophic signs on imaging. This will result in an increased understanding of the interplay between neuroinflammation and neurodegeneration in chronic TBI, as well as a panel of tentative biomarkers that could be used to assess level of disability following TBI and chronic traumatic encephalopathy (CTE)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that had suffered a traumatic brain injury and registered at our local trauma database will be sent a letter asking them for participation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having suffered a traumatic brain injury and being treated at the Karolinska University Hospital between 2007 and 2015.\n* Age \\>18 years of age\n\nExclusion Criteria:\n\n\\- Pregnancy'}, 'identificationModule': {'nctId': 'NCT05235802', 'acronym': 'LONG-TBI', 'briefTitle': 'Long-term Follow-up in Severe Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Long-term Follow-up in Severe Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '2021-02010'}, 'secondaryIdInfos': [{'id': '4-1857 /2021', 'type': 'OTHER', 'domain': 'Karolinska Institutet'}, {'id': 'K 2021-5631', 'type': 'OTHER', 'domain': 'Karolinska University Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with traumatic brain injury about 10 years ago', 'description': 'Patients that had suffered a TBI and being managed at the Neurosurgical Department at the Karolinska University Hospital between 2007 and 2015.', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging (MRI) (including functional MRI)', 'Diagnostic Test: Blood sampling (serum/plasma preparation)', 'Diagnostic Test: Cerebrospinal fluid (CSF)', 'Diagnostic Test: Clinical assessments / questionnaires']}], 'interventions': [{'name': 'Magnetic Resonance Imaging (MRI) (including functional MRI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will undergo magnetic resonance imaging including the following protocols:\n\n* 3D T1w MPRAGE\n* 3D T2w FLAIR SPACE\n* 3D T2w SPACE\n* 3D T1w PSIR (cortical visualization)\n* 2D synthetic MRI (quantitative T1, T2, PD and myelin quantification)\n* Resting-state fMRI (6 min, human connectome protocol, 2 mm iso)\n* 3D SWI\n* DWI b1000 32 directions and b3000 64 directions.', 'armGroupLabels': ['Patients with traumatic brain injury about 10 years ago']}, {'name': 'Blood sampling (serum/plasma preparation)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood will be screened for genetic modifications. Serum will be analyzed for auto-antibodies and other inflammatory and neurodegenerative biomarkers.', 'armGroupLabels': ['Patients with traumatic brain injury about 10 years ago']}, {'name': 'Cerebrospinal fluid (CSF)', 'type': 'DIAGNOSTIC_TEST', 'description': 'CSF will be analyzed for inflammatory and neurodegenerative biomarkers.', 'armGroupLabels': ['Patients with traumatic brain injury about 10 years ago']}, {'name': 'Clinical assessments / questionnaires', 'type': 'DIAGNOSTIC_TEST', 'description': "* Glasgow Outcome Scale Extended (functional outcome)\n* Short-Form 36 (quality of life),\n* EQ-5D (quality of life),\n* Mini-Mental State Extended (MMSE) (mental state assessment).\n* Barthel Index (daily living disabilities),\n* Montgomery-Åsberg Depression Score (MADRS-S) (level of depression)\n* Fatigue Severity Scale (FSS) (level of fatigue)\n\nOther than that, neurological assessments focusing on the Unified Parkinson's Disease Rating Scale (UPDRS) will be performed.", 'armGroupLabels': ['Patients with traumatic brain injury about 10 years ago']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17164', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Susanna Friberg, MD', 'role': 'CONTACT', 'email': 'susanna.friberg@regionstockholm.se'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Eric P Thelin, MD, PhD', 'role': 'CONTACT', 'email': 'eric.thelin@ki.se', 'phone': '0046724654531'}, {'name': 'Susanna Friberg, MD', 'role': 'CONTACT', 'email': 'susanna.friberg@sll.se'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to local laws and regulations, we will not be able to share IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator (MD, PhD), Associate Professor', 'investigatorFullName': 'Eric Thelin', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}