Brain Outcome After Cardiac Arrest - Intervention

NCT05133869 | Unknown DMC

• 1 other identifier: NL77453.068.21
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Heart Arrest, Out-Of-Hospital; Cognitive Impairment

Keywords

Cardiac Arrest; Cognitive Rehabilitation; Neuroplasticity; Cognitive training

Outcome Measures

Primary Outcomes (1)

• Change in main daily problem

  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.

  85 measurements in 150 days

Secondary Outcomes (2)

• Change in other daily problems

  85 measurements in 150 days

• Change in general functioning

  85 measurements in 150 days

Other Outcomes (21)

• Change in neuropsychological assessment score: Memory, Auditory Verbal Learning Test

  < day 1 (before baseline), after baseline (day 15-35 depending on the randomisation), after intervention (day 57 - 77 depending on the randomisation), after follow-up (day 150)

• Change in neuropsychological assessment score: Memory, Rivermead Behavioural Memory Test-Stories

  < day 1 (before baseline)

• Change in neuropsychological assessment score: executive functioning, Digit Span backward

  < day 1 (before baseline)

Study Arms (1)

Baseline + intervention + follow up

EXPERIMENTAL

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.

Device: Metacognitive training + direct training

Interventions

Metacognitive training + direct training DEVICE

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.

Also known as: Rehacom

Baseline + intervention + follow up

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, a subject must be mentally competent and meet all of the following criteria:
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maastricht University: lead
• Rijnstate Hospital: collaborator
• Adelante, Centre of Expertise in Rehabilitation and Audiology: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (3)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

RECRUITING

Adelante

Hoensbroek, Limburg, Netherlands

NOT YET RECRUITING

Maastricht University

Maastricht, Limburg, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Cognitive Dysfunction; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Caroline van Heugten, prof

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline van Heugten, prof

CONTACT

31-43-3884091; caroline.vanheugten@maastrichtuniversity.nl

Jeannette Hofmeijer, prof

CONTACT

JHofmeijer@rijnstate.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants receive the same intervention, therefore there is no masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized multiple baseline single case experimental design (SCED) intervention study.

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: November 24, 2021
• Study Start: April 21, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)