COMPuter-assisted Self-training to Improve EXecutive Function

Study Overview
=================
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 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 600 patients (400 with stroke, 100 after heart attack and 100 with Parkinson's disease) 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.

Official Title
-----------------
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

Conditions
-----------------
Stroke, Parkinson Disease, Cardiac Arrest, Cognitive Dysfunction, Executive Dysfunction

Intervention / Treatment
-----------------
* Behavioral: Computer-based cognitive rehabilitation (CBCR)
* Behavioral: General computer-based cognitive stimulation


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two parallel groups will be included in this study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Specific computer-based cognitive rehabilitation<br>350 patients (200 with stroke, 100 with Parkinson's disease and 50 with heart attack) 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)<br>* CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.<br>|
| Active Comparator: General computer-based cognitive stimulation<br>350 patients (200 with stroke, 100 with Parkinson's disease and 50 with heart attack) 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<br>* For this trial we have developed a webpage for cognitive sham-training, which is designed to provide general computer-based cognitive stimulation.<br>|

What is the study measuring?
-----------------
Primary 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 | 
| CABPad Working Memory Test | Test of spatial working memory. The higher score the better (theoretically infinite score) | At follow-up visit 3 months after the end of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CABPad Working Memory Test - 3 months follow-up after end of intervention | Test of spatial working memory. The higher 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) | 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 | 
| 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 | 
| 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 | 
| 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 | 
| Compliance | Monitoring of total time spent training in minutes | 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. | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
parkinson disease, stroke, cardiac arrest, executive dysfunction, cognitive dysfunction, computer-based cognitive rehabilitation