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

Traumatic Brain Injury Clinical Trial

— BRAINReADAPT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05499806
• Other study ID #: NL79072.042.21
• Status: Enrolling by invitation
• Start date: March 18, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: August 2022
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: February 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Brain Injuries, Traumatic
• Cerebrovascular Accident
• Hemorrhage
• Stroke
• Subarachnoid Hemorrhage
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Netherlands	Revalidatiecentrum Heliomare Wijk aan Zee	Wijk Aan Zee
Netherlands	Isala klinieken	Zwolle	Overijssel

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of the ABI-effect	The percentage of patients experiencing the ABI-effect. Also, a 95% confidence interval of this prevalence will be calculated.	A minimum of 5 years after ABI
Secondary	Cognitive functions of patients and healthy volunteers	The significant difference in cognitive functions between the patient groep and the healthy controls	A minimum of 5 years after ABI for patients