Back to resultsCOMPuter-assisted Self-training to Improve EXecutive Function (COMPEX)
Primary Purpose
Parkinson Disease, Stroke, Cardiac Arrest
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Computer-based cognitive rehabilitation (CBCR)
General computer-based cognitive stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring parkinson disease, stroke, cardiac arrest, executive dysfunction, cognitive dysfunction, computer-based cognitive rehabilitation
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 4 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 4 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
Sites / Locations
- Bispebjerg HospitalRecruiting
- RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Specific computer-based cognitive rehabilitation
General computer-based cognitive stimulation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
CABPad Working Memory Test
Test of spatial working memory. The higher score the better (theoretically infinite score)
Secondary Outcome Measures
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)
Trail Making A
Test of processing speed and visual attention. The lower score the better (theoretically infinite score)
Trail Making A
Test of processing speed and visual attention. The lower score the better (theoretically infinite score)
Trail Making B
Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)
Trail Making B
Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)
SDMT
Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)
SDMT
Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)
Phonological verbal fluency test
Test of verbal phonological fluency. The higher score the better (theoretically infinite score)
Phonological verbal fluency test
Test of verbal phonological fluency. The higher score the better (theoretically infinite score)
Categorical verbal fluency test
Test of verbal categorical fluency. The higher score the better (theoretically infinite score)
Categorical verbal fluency test
Test of verbal categorical fluency. The higher score the better (theoretically infinite score)
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
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
mrs: Modified Rankin Scale
Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead): Higher score indicates more severe disability.
mrs: Modified Rankin Scale
Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead). Higher score indicates more severe disability.
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.
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.
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
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
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.
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.
Compliance
Monitoring of total time spent training in minutes
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.
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.
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.
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.
Full Information
NCT ID
NCT04229056
First Posted
January 3, 2020
Last Updated
February 7, 2023
Sponsor
Bispebjerg Hospital
Collaborators
Rigshospitalet, Denmark, University of Glasgow, University of Basel, Copenhagen Trial Unit, Center for Clinical Intervention Research, Hjernesagen, Göteborg University
1. Study Identification
Unique Protocol Identification Number
NCT04229056
Brief Title
COMPuter-assisted Self-training to Improve EXecutive Function
Acronym
COMPEX
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
Rigshospitalet, Denmark, University of Glasgow, University of Basel, Copenhagen Trial Unit, Center for Clinical Intervention Research, Hjernesagen, Göteborg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Stroke, Cardiac Arrest, Cognitive Dysfunction, Executive Dysfunction
Keywords
parkinson disease, stroke, cardiac arrest, executive dysfunction, cognitive dysfunction, computer-based cognitive rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two parallel groups will be included in this study
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Specific computer-based cognitive rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
General computer-based cognitive stimulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computer-based cognitive rehabilitation (CBCR)
Intervention Description
CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.
Intervention Type
Behavioral
Intervention Name(s)
General computer-based cognitive stimulation
Intervention Description
For this trial we have developed a webpage for cognitive sham-training, which is designed to provide general computer-based cognitive stimulation.
Primary Outcome Measure Information:
Title
Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)
Description
Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
CABPad Working Memory Test
Description
Test of spatial working memory. The higher score the better (theoretically infinite score)
Time Frame
At follow-up visit 3 months after the end of the intervention
Secondary Outcome Measure Information:
Title
CABPad Working Memory Test - 3 months follow-up after end of intervention
Description
Test of spatial working memory. The higher score the better (theoretically infinite score)
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
Trail Making A
Description
Test of processing speed and visual attention. The lower score the better (theoretically infinite score)
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
Trail Making A
Description
Test of processing speed and visual attention. The lower score the better (theoretically infinite score)
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
Trail Making B
Description
Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
Trail Making B
Description
Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
SDMT
Description
Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
SDMT
Description
Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
Phonological verbal fluency test
Description
Test of verbal phonological fluency. The higher score the better (theoretically infinite score)
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
Phonological verbal fluency test
Description
Test of verbal phonological fluency. The higher score the better (theoretically infinite score)
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
Categorical verbal fluency test
Description
Test of verbal categorical fluency. The higher score the better (theoretically infinite score)
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
Categorical verbal fluency test
Description
Test of verbal categorical fluency. The higher score the better (theoretically infinite score)
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
Fear questionnaire
Description
Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
Fear questionnaire
Description
Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of avoidance due to fear
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
mrs: Modified Rankin Scale
Description
Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead): Higher score indicates more severe disability.
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
mrs: Modified Rankin Scale
Description
Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead). Higher score indicates more severe disability.
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)
Description
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.
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)
Description
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.
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
EuroQol-5 domain (EQ-5D-5L)
Description
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
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
EuroQol-5 domain (EQ-5D-5L)
Description
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
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinson Disease)
Description
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.
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinsons Disease)
Description
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.
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
Compliance
Description
Monitoring of total time spent training in minutes
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
PHQ-9 (Patient health questionnaire 9)
Description
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.
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
PHQ-9 (Patient health questionnaire 9)
Description
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.
Time Frame
At follow-up visit 3 months after the end of the intervention
Title
2) visual analogue scale (1-10)
Description
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.
Time Frame
Directly after the intervention, eight weeks after inclusion
Title
Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)
Description
Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.
Time Frame
Directly after the intervention, eight weeks after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanne Christensen, Professor
Phone
+45 38 63 50 70
Email
hanne.krarup.christensen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Katrine Sværke, M.Sc. Psych.
Phone
004521251087
Email
katrine.svaerke.schioeler@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanne Christensen, Professor
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanne Christensen, MD, Professor
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesper Kjaergaard, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
This is currently undecided
Learn more about this trial
COMPuter-assisted Self-training to Improve EXecutive Function
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