People who suffered a cardiac arrest are often have cognitive impairments. In this study the investigators test the effectiveness of an intervention, combining direct training and metacognitive training, in a single case experimental design (SCED).
Full Title of Study: “BROCA-intervention Brain Outcome After Cardiac Arrest- Single Case Experimental Design Intervention Study”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: November 2022
SUMMARY Rationale: The survival rate of patients after cardiac arrest and resuscitation has increased considerably. A common consequence of cardiac arrest is ischemic-hypoxic brain damage leading to cognitive impairment. Currently, there is a lack of knowledge regarding effectiveness of treatments to improve outcomes of patients with cognitive impairment after a cardiac arrest. Objective: The primary objective is to test effectiveness of cognitive rehabilitation therapy to improve functioning on problematic well-defined personalized behaviour that is caused by an objective cognitive impairments after OHCA. Secondary objectives are to test the generalisation of the effect of the intervention towards other aspects of daily living, to estimate the effect of the intervention on objective and subjective measures of cognitive functioning, participation in society, and quality of life, and to detect evidence of neuroplasticity in MRI data. Study design: This is a randomized multiple baseline single case experimental design (SCED) intervention study. Study population: The four to six participants included in this study will be patients surviving a cardiac arrest and cardiopulmonary resuscitation with remaining cognitive impairments at least 3 months after the cardiac arrest, who are motivated to adhere to the training program tested in this study. Intervention: The intervention will consist of a combination of direct training of the impaired cognitive function(s) and metacognitive strategy training for 42 days (6 weeks). Direct training will be done with the computer program Rehacom to train the impaired cognitive domains, for 20 minutes 5 times a week. Metacognitive strategy training will be given on a weekly or biweekly basis (6-10 sessions) by a trained therapist as current care. Main study parameters/endpoints: The primary outcome measure is the score on a Visual Analogue Scale (VAS) of the severity of the main, predefined daily life problem caused by objective cognitive impairment(s) that the participant is dealing with. The primary outcome measure will be collected by an App, through which the patient will receive questions on his / her telephone, daily. Answering will take less than one minute. Secondary outcome measures are daily obtained VAS scores on general and potential other daily life problems, and scores on neuropsychological tests and questionnaires that are obtained four times during the study, and MRI data obtained at two different time-points. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators foresee no relevant additional risk of cognitive rehabilitation therapy and follow up in this study. Daily training and collection of outcomes will be challenging, but feasible, since the investigators will include motivated patients who will mostly judge the careful follow up as pleasant and attentive. MRI scanning is only performed in patients suitable for scanning, no contrasts are used. Potential benefit from participation in this study is follow up and treatment of cognitive impairments may lead to improved functional recovery after cardiac arrest.
- Device: Metacognitive training + direct training
- The intervention will consist of a combination of direct training of the impaired cognitive function(s) and metacognitive strategy training for 42 days (6 weeks). Direct training will be done with the computer program Rehacom for 20 minutes, 5 times a week. Metacognitive strategy training will be given on a weekly or biweekly basis (6-10 sessions) by a trained therapist at Adelante. Rehacom is a brain training program developed to improve a variety of cognitive functions with the use of game-like cognitive training modules. During the intervention the participant should train with Rehacom for approximately 600 minutes in total. In addition to the direct training, the participant receives six to ten sessions of metacognitive strategy training. During this training they are taught strategies by a therapist to improve their performance on the Rehacom modules and on daily life functioning. Each metacognitive strategy is linked to one of the Rehacom modules.
Arms, Groups and Cohorts
- Experimental: Baseline + intervention + follow up
- All participants receive the same treatment in the same order. First there is a phase without treatment, the baseline phase. The length of this phase is randomly assigned to each participant. Then all participants follow a 42 day intervention, in which direct training and metacognitive training is combined. Afterwards they have a follow-up period, this length of this period is counterbalanced with the length of the baseline period so that the full study adds up to 150 days.
Clinical Trial Outcome Measures
- Change in main daily problem
- Time Frame: 85 measurements in 150 days
- A Visual Analogue Scale (VAS) from 0 to 100 with higher scores meaning a worse outcome, of the severity of the predefined daily life problem caused by an objective cognitive impairment that the participant is dealing with.
- Change in other daily problems
- Time Frame: 85 measurements in 150 days
- This measure consists of a VAS from 0 to 100 with higher scores meaning a worse outcome, of other potential personal daily life problems caused by the objective cognitive impairment next to the primary outcome measure.
- Change in general functioning
- Time Frame: 85 measurements in 150 days
- This measure consists of a VAS from 0 to 100 with higher scores meaning a worse outcome, of the problems in general cognitive domains (memory, planning/complex tasks, and attention).
Participating in This Clinical Trial
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).
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Maastricht University
- Rijnstate Hospital
- Provider of Information About this Clinical Study
- Overall Official(s)
- Caroline van Heugten, prof, Principal Investigator, Maastricht University
- Overall Contact(s)
- Caroline van Heugten, prof, 31-43-3884091, firstname.lastname@example.org
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.