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

NCT05499806 | Unknown DMC

• 1 other identifier: NL79072.042.21
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 2

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.

Conditions

Acquired Brain Injury; Subarachnoid Hemorrhage; Traumatic Brain Injury; Cerebrovascular Accident

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cognitive functions of patients and healthy volunteers

  A minimum of 5 years after ABI for patients

Study Arms (2)

Acquired Brain Injury Patients

Questionnaire and, if the requirements are met, a neuropsychological assessment.

Healthy volunteers

Questionnaire and, if the requirements are met, a neuropsychological assessment.

Eligibility Criteria

• Age: 50 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (2)

Isala klinieken

Zwolle, Overijssel, 8025 AB, Netherlands

Location

Revalidatiecentrum Heliomare Wijk aan Zee

Wijk aan Zee, Netherlands

Location

MeSH Terms

Conditions

Brain Injuries; Subarachnoid Hemorrhage; Brain Injuries, Traumatic; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. J. van der Naalt

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 12, 2022
• Study Start: March 18, 2022
• Primary Completion: March 1, 2023
• Study Completion: February 1, 2024
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)