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:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
Cohort Study on the Effects of Aging in Acquired Brain Injury Patients
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRAINReADAPT
Brief Summary:
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.
Detailed Description:
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.
Primary objective:
Explore the prevalence of the ABI-effect, by mapping the participation level.
Secondary objective:
Substantiate the occurence of the ABI-effect, by mapping cognitive functions of patients and compare these to healthy controls.
Tertiary objective:
Gain insight in the need of care for patients, to enhance regular care after ABI.
Primary objective:
Explore the prevalence of the ABI-effect, by mapping the participation level.
Secondary objective:
Substantiate the occurence of the ABI-effect, by mapping cognitive functions of patients and compare these to healthy controls.
Tertiary objective:
Gain insight in the need of care for patients, to enhance regular care after ABI.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: