COMPuter-assisted Self-training to Improve EXecutive Function

NCT ID: NCT04229056

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2026-06-30

Brief Summary

This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to generally cognitively stimulating activities on a computer

Detailed Description

This project explores the effects of specialized computer-based cognitive rehabilitation (CBCR) targeting executive functions in three groups of patients: Stroke, Cardiac Arrest and Parkinson's Disease. The effect of specialized CBCR is compared to completing generally cognitively stimulating activities on a computer. A total of 307 patients is expected to be enrolled. All patients will complete a neuropsychological test battery assessing executive functions at inclusion, directly after the eight-week training period and at follow-up three months after the end of the intervention period. Furthermore, all patients will answer questionnaires concerning quality of life and ADL-measures at baseline, after the intervention and at follow-up. All patients will train for a period of 8 weeks, 5 times a week for 60 minutes regardless of their group allocation.

Conditions

Parkinson Disease; Stroke; Cardiac Arrest; Cognitive Dysfunction; Executive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Specific computer-based cognitive rehabilitation

154 patients will be allocated to specific computer-based cognitive rehabilitation. This group will train with 10 exercises from the cognitive rehabilitation software 'Scientific Brain training PRO'. These 10 exercises are designed to train various executive functions.

Group Type: EXPERIMENTAL

Computer-based cognitive rehabilitation (CBCR)

Intervention Type: BEHAVIORAL

CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.

General computer-based cognitive stimulation

154 patients will be allocated to general computer-based cognitive stimulation. This group will train with 10 generally mentally stimulating games on a website specifically designed for this trial. These 10 games are chosen because they are believed to have a low load on executive functions but stimulate over-all concentration and visuoperceptual abilities.

Group Type: ACTIVE_COMPARATOR

General computer-based cognitive stimulation

Intervention Type: BEHAVIORAL

For this trial we have developed a webpage for general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation.

Interventions

Computer-based cognitive rehabilitation (CBCR)

CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.

Intervention Type: BEHAVIORAL

General computer-based cognitive stimulation

For this trial we have developed a webpage for general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• A diagnose of stroke, cardiac arrest or Parkinson's disease.
• Aged 18 years or older.
• Impaired working memory measured with CABPad working memory test, cut off for inclusion: 5 symbols or less backwards
• Computer and internet access at home.
• Providing informed consent.

• Inclusion within 6 months post-stroke
• Stroke confirmed by clinical findings and imaging, both AIS and ICH is allowed.
• Initial stroke severity >/= NIHSS 3.

• Inclusion within 6 months post ictus.

• Clinical diagnosis of PD.
• Anti-parkinsonian medical treatment (dopaminergic or other).

Exclusion Criteria

• Informed consent not provided
• Other neurological or psychiatric disease which is expected to influence the patient's ability to participate in the trial according to the investigator
• Not able to participate according to investigator

• Patients with massive anosognosia for executive dysfunction or patients with no subjective feeling of executive dysfunction (Patient sustains total denial of executive symptoms over time)
• Patients with severe aphasia, in which it is unclear whether the patient's performance on a neuropsychological test-battery is due to aphasia and not executive dysfunction.

• Diagnosis of PD Dementia according to the MDS PD Dementia criteria

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

University of Glasgow

OTHER

Sponsor Role: collaborator

University of Basel

OTHER

Sponsor Role: collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

Sponsor Role: collaborator

Hjernesagen

UNKNOWN

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: collaborator

Neurorehabilitering - Kbh, City of Copenhagen

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hanne Christensen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanne Christensen, Professor

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status: RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Hanne Christensen, Professor

Role: CONTACT

hanne.krarup.christensen@regionh.dk

+45 38 63 50 70

Katrine Sværke, M.Sc. Psych.

Role: CONTACT

katrine.svaerke.schioeler@regionh.dk

004521251087

Facility Contacts

Hanne Christensen, MD, Professor

Role: primary

Jesper Kjaergaard, MD

Role: primary

Other Identifiers

H-19039236

Identifier Type: -

Identifier Source: org_study_id