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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Parkinson Disease; Cognitive Dysfunction; Cardiac Arrest; Executive Dysfunction
• Intervention / Treatment: Behavioral: Computer-based cognitive rehabilitation (CBCR); Behavioral: General computer-based cognitive stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 307
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanne Christensen, Professor; Phone Number: +45 38 63 50 70; Email: hanne.krarup.christensen@regionh.dk
• Study Contact Backup: Name: Katrine Sværke, M.Sc. Psych.; Phone Number: 004521251087; Email: katrine.svaerke.schioeler@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Rigshospitalet
    • Contact: Jesper Kjaergaard, MD
  • Copenhagen, Denmark
    • Recruiting
    • Bispebjerg Hospital
    • Contact: Hanne Christensen, MD, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 criteria specific for stroke

• 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 criteria specific for cardiac arrest

• Inclusion within 6 months post ictus.

Inclusion criteria specific for Parkinson's disease

• 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

Exclusion criteria specific for stroke

• 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.

Exclusion criteria specific for cardiac arrest • None

Exclusion criteria specific for PD

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Computer-based cognitive rehabilitation (CBCR); CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)	Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.	At follow-up visit 3 months after the end of the intervention
Trail Making A	Test of processing speed and visual attention. The lower score the better (theoretically infinite score)	Directly after the intervention, eight weeks after inclusion
Trail Making A	Test of processing speed and visual attention. The lower score the better (theoretically infinite score)	At follow-up visit 3 months after the end of the intervention
Trail Making B	Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)	Directly after the intervention, eight weeks after inclusion
Trail Making B	Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)	At follow-up visit 3 months after the end of the intervention
SDMT	Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)	Directly after the intervention, eight weeks after inclusion
SDMT	Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)	At follow-up visit 3 months after the end of the intervention
Categorical verbal fluency test	Test of verbal categorical fluency. The higher score the better (theoretically infinite score)	Directly after the intervention, eight weeks after inclusion
Categorical verbal fluency test	Test of verbal categorical fluency. The higher score the better (theoretically infinite score)	At follow-up visit 3 months after the end of the intervention
Compliance	Monitoring of total time spent training in minutes	Directly after the intervention, eight weeks after inclusion
2) visual analogue scale (1-10)	After last session: how much they liked doing the training and if they would recommend the intervention to somebody else in their situation. Higher score indicates they liked the training more.	Directly after the intervention, eight weeks after inclusion
Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)	Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.	Directly after the intervention, eight weeks after inclusion
Phonological verbal fluency test	Test of verbal phonological fluency. The higher score the better (theoretically infinite score)	Directly after the intervention, eight weeks after inclusion
Phonological verbal fluency test	Test of verbal phonological fluency. The higher score the better (theoretically infinite score)	At follow-up visit 3 months after the end of the intervention
Fear questionnaire	Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear	Directly after the intervention, eight weeks after inclusion
Fear questionnaire	Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear	At follow-up visit 3 months after the end of the intervention
mrs: Modified Rankin Scale	Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead): Higher score indicates more severe disability.	Directly after the intervention, eight weeks after inclusion
mrs: Modified Rankin Scale	Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead). Higher score indicates more severe disability.	At follow-up visit 3 months after the end of the intervention
IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)	Cognitive decline in the elderly, reported by partner. A scale of 16 items from 1 (much better) to 5 (much worse). Higher score indicates more severe disability.	Directly after the intervention, eight weeks after inclusion
IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)	Cognitive decline in the elderly, reported by partner. A scale of 16 items from 1 (much better) to 5 (much worse). Higher score indicates more severe disability.	At follow-up visit 3 months after the end of the intervention
EuroQol-5 domain (EQ-5D-5L)	Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disability . Higher score indicates more severe disability. Completed by patient and partner	Directly after the intervention, eight weeks after inclusion
EuroQol-5 domain (EQ-5D-5L)	Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disability. Higher score indicates more severe disability. Completed by patient and partner	At follow-up visit 3 months after the end of the intervention
PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinson Disease)	Quality of Life questionnaire in patients with Parkinson's Disease. A scale with 39 items rated from 1 (never) to 5 (all the time / Can not do at all). Higher score indicates more severe disability.	Directly after the intervention, eight weeks after inclusion
PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinsons Disease)	Quality of Life questionnaire in patients with Parkinson's Disease. A scale with 39 items rated from 1 (never) to 5 (all the time / Can not do at all). Higher score indicates more severe disability.	At follow-up visit 3 months after the end of the intervention
PHQ-9 (Patient health questionnaire 9)	Questionnaire about health of patient with 9 items rated on a 4 point scale from 0 (not at all) to 3 (almost every day). Higher score indicates more severe disability.	Directly after the intervention, eight weeks after inclusion
PHQ-9 (Patient health questionnaire 9)	Questionnaire about health of patient with 9 items rated on a 4 point scale from 0 (not at all) to 3 (almost every day). Higher score indicates more severe disability.	At follow-up visit 3 months after the end of the intervention
CABPad Working Memory Test - 3 months follow-up	Test of working memory. The higher score the better (theoretically infinite score)	At follow-up visit 3 months after end of intervention

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Göteborg University; Rigshospitalet, Denmark; University of Basel; Aalborg University Hospital; University of Glasgow; Copenhagen Trial Unit, Center for Clinical Intervention Research; Neurorehabilitering - Kbh, City of Copenhagen; Hjernesagen
• Investigators: Principal Investigator: Hanne Christensen, Professor, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: stroke; cardiac arrest; cognitive dysfunction; parkinson disease; executive dysfunction; computer-based cognitive rehabilitation
• Additional Relevant MeSH Terms: Synucleinopathies; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Heart Diseases; Neurocognitive Disorders; Cognition Disorders; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Stroke; Cognitive Dysfunction; Heart Arrest; Parkinson Disease
• Other Study ID Numbers: H-19039236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is currently undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No