Cognitive rehabilitation for patients after cardiac arrest
BROCA-intervention Brain Outcome After Cardiac Arrest- Single Case Experimental Design Intervention Study
NA · Maastricht University · NCT05133869
This study tests a new brain training program to help people who have had a cardiac arrest improve their thinking skills and daily activities.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Maastricht University (other) |
| Locations | 3 sites (Arnhem, Gelderland and 2 other locations) |
| Trial ID | NCT05133869 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a cognitive rehabilitation intervention for individuals who have experienced a cardiac arrest and are suffering from cognitive impairments. The intervention combines direct cognitive training with metacognitive strategies to enhance cognitive functioning and daily living skills. Participants will be assessed using a single case experimental design, focusing on personalized behavioral improvements and the potential for neuroplasticity as observed through MRI data. The study aims to provide insights into effective rehabilitation strategies for this population.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-75 who have survived a cardiac arrest and exhibit cognitive impairments at least 3 months post-event.
Not a fit: Patients who do not have cognitive impairments or those who are not motivated to participate in the training program may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive functioning and quality of life for patients recovering from cardiac arrest.
How similar studies have performed: While cognitive rehabilitation for cardiac arrest survivors is an emerging field, similar approaches have shown promise in improving cognitive outcomes in other populations, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, a subject must be mentally competent and meet all of the following criteria: * Objectified cardiac arrest between 3 months and 2 years before inclusion. * Age 18 - 75 * Cognitive impairments objectified by a score on the Montreal Cognitive Assessment (MoCA) ≤ 26 or abnormal scores on a neuropsychological assessment caused by low scores (more than 1,5 standard deviation below the mean of the norm group) on memory, attention, and/or executive functioning tasks * Living independently (with minor help) * Experiencing difficulties with more complex daily tasks (e.g. doing groceries, following conversations, etc.) * Motivated to improve cognitive functioning and to participate in the study * Proficient in Dutch to understand instructions, follow the training program and fill in the questionnaires * Patients with a treatment indication for cognitive rehabilitation (as decided by a psychiatrist) * Written informed consent Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Neurodegenerative disorder, or another brain disease known to impact cognition, such as stroke or dementia * Substance abuse impacting cognition * Psychiatric disorder in need of treatment * Uncorrected visual or auditory deficiencies * Not in possession of a computer or lack of computer skills * Severe amnesia or aphasia * Illiteracy * In case of MRI contra-indications, such as an ICD or metallic implants, patients will be excluded from the MRI sub-study. The full list of contraindications can be found in the article of Ghadimi and Sapra (2020).
Where this trial is running
Arnhem, Gelderland and 2 other locations
- Rijnstate Hospital — Arnhem, Gelderland, Netherlands (RECRUITING)
- Adelante — Hoensbroek, Limburg, Netherlands (NOT_YET_RECRUITING)
- Maastricht University — Maastricht, Limburg, Netherlands (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Caroline van Heugten, prof — Maastricht University
- Study coordinator: Caroline van Heugten, prof
- Email: caroline.vanheugten@maastrichtuniversity.nl
- Phone: 31-43-3884091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Arrest, Out-Of-Hospital, Cognitive Impairment, Cardiac Arrest, Cognitive Rehabilitation, Neuroplasticity, Cognitive training