COMPuter-assisted Self-training to Improve EXecutive Function
COMPEX
Computer-Assisted Self-Training to Improve Executive Function Versus Unspecific Training in Patients After Stroke, Cardiac Arrest or in Parkinson's Disease: a Randomized Controlled Trial
1 other identifier
interventional
307
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Jun 2020
Longer than P75 for not_applicable parkinson-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2020
CompletedFirst Posted
Study publicly available on registry
January 14, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedFebruary 20, 2025
February 1, 2025
5.6 years
January 3, 2020
February 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CABPad Working Memory Test
Test of working memory. The higher score the better (theoretically infinite score)
After the end of the intervention (8 weeks after baseline)
Secondary Outcomes (27)
CABPad Working Memory Test - 3 months follow-up
At follow-up visit 3 months after end of intervention
Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)
At follow-up visit 3 months after the end of the intervention
Trail Making A
Directly after the intervention, eight weeks after inclusion
Trail Making A
At follow-up visit 3 months after the end of the intervention
Trail Making B
Directly after the intervention, eight weeks after inclusion
- +22 more secondary outcomes
Study Arms (2)
Specific computer-based cognitive rehabilitation
EXPERIMENTAL154 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.
General computer-based cognitive stimulation
ACTIVE COMPARATOR154 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.
Interventions
CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.
For this trial we have developed a webpage for general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation.
Eligibility Criteria
You may qualify if:
- A diagnose of stroke, cardiac arrest or Parkinson's disease.
- Aged 18 years or older.
- Computer and internet access at home.
- Providing informed consent.
- Stroke confirmed by clinical findings and imaging, both AIS and ICH is allowed.
- Initial stroke severity \>/= NIHSS 3.
- Clinical diagnosis of PD.
- Anti-parkinsonian medical treatment (dopaminergic or other).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bispebjerg Hospitallead
- Rigshospitalet, Denmarkcollaborator
- University of Glasgowcollaborator
- University of Baselcollaborator
- Copenhagen Trial Unit, Center for Clinical Intervention Researchcollaborator
- Hjernesagencollaborator
- Göteborg Universitycollaborator
- Aalborg University Hospitalcollaborator
- Neurorehabilitering - Kbh, City of Copenhagencollaborator
Study Sites (2)
Bispebjerg Hospital
Copenhagen, Denmark
Rigshospitalet
Copenhagen, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hanne Christensen, Professor
Bispebjerg Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Because of the nature of the intervention, masking participants and investigators is not possible. Outcome assessors will be masked to the group allocation of participants.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 3, 2020
First Posted
January 14, 2020
Study Start
June 1, 2020
Primary Completion
December 31, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
February 20, 2025
Record last verified: 2025-02