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Cohort Study on the Effects of Aging in Acquired Brain Injury Patients (BRAINReADAPT)

U

University Medical Center Groningen (UMCG)

Status

Invitation-only

Conditions

Cerebrovascular Accident
Subarachnoid Hemorrhage
Traumatic Brain Injury
Acquired Brain Injury

Study type

Observational

Funder types

Other

Identifiers

NCT05499806
NL79072.042.21

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

50 to 67 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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]
  • Able to complete questionnaires independently

Additionally, patients must also meet the following criteria:

  • Age of acquiring the ABI ≧ 25 years [Rationale: the brain is supposed to be fully developed at a maximum capacity
  • 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]
  • ABI diagnosis at hospital admission with abnormalities at the brain-CT or MRI
  • Independent regarding Activities of Daily Living
  • Not living in a long-term care facility

Exclusion criteria

  • Psychiatric disease (for which participant is currently treated)
  • Accompanying disease with reduced life expectancy
  • Neurological disease (including recurrent ABI for patients)
  • Language barriers prohibiting and completion of Dutch questionnaires
  • Alcohol or drug abuse
  • Suspected neurodegenerative disease

Trial design

800 participants in 2 patient groups

Acquired Brain Injury Patients
Description:
Questionnaire and, if the requirements are met, a neuropsychological assessment.
Healthy volunteers
Description:
Questionnaire and, if the requirements are met, a neuropsychological assessment.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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