Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT05499806
Status:
UNKNOWN
Last Update Posted:
2022-08-12
First Post:
2022-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cohort Study on the Effects of Aging in Acquired Brain Injury Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-11', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-08-11', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of the ABI-effect', 'timeFrame': 'A minimum of 5 years after ABI', 'description': 'The percentage of patients experiencing the ABI-effect. Also, a 95% confidence interval of this prevalence will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Cognitive functions of patients and healthy volunteers', 'timeFrame': 'A minimum of 5 years after ABI for patients', 'description': 'The significant difference in cognitive functions between the patient groep and the healthy controls'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acquired Brain Injury', 'Subarachnoid Hemorrhage', 'Traumatic Brain Injury', 'Cerebrovascular Accident']}, 'descriptionModule': {'briefSummary': 'A prospective cohort study (questionnaires), with an embedded case control study (neuropsychological assessments) in which the data is gathered within a timeframe of 3 years. A group of 700 patients and a group of 100 healthy volunteers will be participating.', 'detailedDescription': 'In the Netherlands an estimated 650.000 people live with the daily consequences of an Acquired Brain Injury (ABI). A substantial amount of these patients acquired their brain injury (traumatic brain injury, subarachnoid hemorrhage or cerebrovascular accident) at a relatively young age: between 18 and 50 years old. The chain-of-care for ABI aims for recovery in the subacute phase, usually within a period of one year after injury. After an adaptation period, the patients reach a new balance, with stabilization of complaints and reintegration, sometimes with the necessity of modifications. The group of patients who acquired a brain injury at a young age, have to face the effects of aging like decreased cognitive functions, which can cause the participation level to drop. This is called the ABI-effect in the current study. At this moment, insufficient information is available about the functioning of people who suffered ABI multiple years ago and have established a new balance, and now make the transition to an older phase of live.\n\nPrimary objective:\n\nExplore the prevalence of the ABI-effect, by mapping the participation level.\n\nSecondary objective:\n\nSubstantiate the occurence of the ABI-effect, by mapping cognitive functions of patients and compare these to healthy controls.\n\nTertiary objective:\n\nGain insight in the need of care for patients, to enhance regular care after ABI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have suffered an acute ABI defined by a traumatic brain injury, stroke or subarachnoid haemorrhage who have been admitted at the UMCG or one of the other participating centers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current age range between 50-67 years \\[Rationale: having an age that enables the patient to experience the effects of aging with a low risk of neurodegenerative disease\\]\n* Able to complete questionnaires independently\n\nAdditionally, patients must also meet the following criteria:\n\n* Age of acquiring the ABI ≧ 25 years \\[Rationale: the brain is supposed to be fully developed at a maximum capacity\n* ABI must be ≧ 5 years ago\\] \\[Rationale :time period regarded sufficient to have achieved a stable level of cognitive functioning and participation after an ABI\\]\n* ABI diagnosis at hospital admission with abnormalities at the brain-CT or MRI\n* Independent regarding Activities of Daily Living\n* Not living in a long-term care facility\n\nExclusion Criteria:\n\n* Psychiatric disease (for which participant is currently treated)\n* Accompanying disease with reduced life expectancy\n* Neurological disease (including recurrent ABI for patients)\n* Language barriers prohibiting and completion of Dutch questionnaires\n* Alcohol or drug abuse\n* Suspected neurodegenerative disease'}, 'identificationModule': {'nctId': 'NCT05499806', 'acronym': 'BRAINReADAPT', 'briefTitle': 'Cohort Study on the Effects of Aging in Acquired Brain Injury Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Cohort Study on the Effects of Aging in Acquired Brain Injury Patients', 'orgStudyIdInfo': {'id': 'NL79072.042.21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acquired Brain Injury Patients', 'description': 'Questionnaire and, if the requirements are met, a neuropsychological assessment.'}, {'label': 'Healthy volunteers', 'description': 'Questionnaire and, if the requirements are met, a neuropsychological assessment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8025 AB', 'city': 'Zwolle', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'Isala klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'city': 'Wijk aan Zee', 'country': 'Netherlands', 'facility': 'Revalidatiecentrum Heliomare Wijk aan Zee', 'geoPoint': {'lat': 52.4936, 'lon': 4.59409}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr. J. van der Naalt', 'investigatorFullName': 'Joukje van der Naalt', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}