Parkinson DiseaseCOMPEXNCT04229056
COMPuter-assisted Self-training to Improve EXecutive Function
A study testing Computer-based cognitive rehabilitation (CBCR) and General computer-based cognitive stimulation in people with Parkinson Disease and Stroke, run by Bispebjerg Hospital at 2 sites in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease, Stroke, Cardiac Arrest
- What is being tested?
- Computer-based cognitive rehabilitation (CBCR) and General computer-based cognitive stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jun 2020to 5 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Stroke confirmed by clinical findings and imaging, both AIS and ICH is allowed.
Show all 10Show fewer
- Initial stroke severity >/= NIHSS 3.
- Inclusion within 6 months post ictus.
- Clinical diagnosis of PD.
- Anti-parkinsonian medical treatment (dopaminergic or other).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
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
Read the 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.
- Being tested
- Computer-based cognitive rehabilitation (CBCR), General computer-based cognitive stimulation
- Keywords
- parkinson disease, stroke, cardiac arrest, executive dysfunction, cognitive dysfunction, computer-based cognitive rehabilitation
- Medical subject headings
- Parkinson Disease, Stroke, Heart Arrest, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based cognitive rehabilitation (CBCR)Behavioural
CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.
General computer-based cognitive stimulationBehavioural
For this trial we have developed a webpage for general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Specific computer-based cognitive rehabilitation | Experimental | 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. Receives: Behavioral: Computer-based cognitive rehabilitation (CBCR) |
| General computer-based cognitive stimulation | Active comparator | 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. Receives: Behavioral: General computer-based cognitive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CABPad Working Memory Test
Test of working memory. The higher score the better (theoretically infinite score)
Measured: After the end of the intervention (8 weeks after baseline)
Secondary outcomes (27)
CABPad Working Memory Test - 3 months follow-up
Test of working memory. The higher score the better (theoretically infinite score)
Measured: At follow-up visit 3 months after end of intervention
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: At follow-up visit 3 months after the end of the intervention
Compliance
Monitoring of total time spent training in minutes
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Directly after the intervention, eight weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Jun 2020
- Primary completion5 Nov 2026 (estimated)
- Study completion5 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups will be included in this study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 307 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University of Glasgow, University of Basel, Copenhagen Trial Unit, Center for Clinical Intervention Research, Hjernesagen, Göteborg University, Aalborg University Hospital, Neurorehabilitering - Kbh, City of Copenhagen
- Responsible party
- Principal investigator, Hanne Christensen, Bispebjerg Hospital
- Investigators
- Hanne Christensen, Professor, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229056
- Sponsor's protocol ID
- H-19039236
- Acronym
- COMPEX
- Status last verified
- Sep 2026
- First submitted
- 3 Jan 2020
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is currently undecided
Publications
Svaerke K, Christensen L, Lokkegaard A, Kjaergaard J, Jacobsen JC, Engelter S, Modrau B, Quinn T, Traenka C, Sunnerhagen KS, Christensen H. The COMPEX-trial: computer-based cognitive rehabilitation to improve executive function versus unspecific training in patients after stroke, cardiac arrest or in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2026 Mar 19;27(1):310. doi: 10.1186/s13063-026-09623-5.
PubMed 41857604
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04229056
- Acronym / sponsor ID
- COMPEX / H-19039236
- Keywords
- parkinson disease, stroke, cardiac arrest, executive dysfunction, cognitive dysfunction, computer-based cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 307 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University of Glasgow, University of Basel, Copenhagen Trial Unit, Center for Clinical Intervention Research, Hjernesagen, Göteborg University, Aalborg University Hospital, Neurorehabilitering - Kbh, City of Copenhagen
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 5 Feb 2027 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups will be included in this study
| Arm | Type | Receives |
|---|---|---|
| Specific computer-based cognitive rehabilitation | Experimental | Behavioral: Computer-based cognitive rehabilitation (CBCR)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. |
| General computer-based cognitive stimulation | Active comparator | Behavioral: General computer-based cognitive stimulation154 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-based cognitive rehabilitation (CBCR)CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions. | Behavioural | Specific computer-based cognitive rehabilitation |
| General computer-based cognitive stimulationFor this trial we have developed a webpage for general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation. | Behavioural | General computer-based cognitive stimulation |
Primary outcome
CABPad Working Memory Test
Time frame: After the end of the intervention (8 weeks after baseline)
Test of working memory. The higher score the better (theoretically infinite score)
27 secondary outcomes
CABPad Working Memory Test - 3 months follow-up
Time frame: At follow-up visit 3 months after end of intervention
Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)
Time frame: At follow-up visit 3 months after the end of the intervention
Trail Making A
Time frame: Directly after the intervention, eight weeks after inclusion
Trail Making A
Time frame: At follow-up visit 3 months after the end of the intervention
Trail Making B
Time frame: Directly after the intervention, eight weeks after inclusion
Trail Making B
Time frame: At follow-up visit 3 months after the end of the intervention
SDMT
Time frame: Directly after the intervention, eight weeks after inclusion
SDMT
Time frame: At follow-up visit 3 months after the end of the intervention
Phonological verbal fluency test
Time frame: Directly after the intervention, eight weeks after inclusion
Phonological verbal fluency test
Time frame: At follow-up visit 3 months after the end of the intervention
Categorical verbal fluency test
Time frame: Directly after the intervention, eight weeks after inclusion
Categorical verbal fluency test
Time frame: At follow-up visit 3 months after the end of the intervention
Fear questionnaire
Time frame: Directly after the intervention, eight weeks after inclusion
Fear questionnaire
Time frame: At follow-up visit 3 months after the end of the intervention
mrs: Modified Rankin Scale
Time frame: Directly after the intervention, eight weeks after inclusion
mrs: Modified Rankin Scale
Time frame: At follow-up visit 3 months after the end of the intervention
IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)
Time frame: Directly after the intervention, eight weeks after inclusion
IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)
Time frame: At follow-up visit 3 months after the end of the intervention
EuroQol-5 domain (EQ-5D-5L)
Time frame: Directly after the intervention, eight weeks after inclusion
EuroQol-5 domain (EQ-5D-5L)
Time frame: At follow-up visit 3 months after the end of the intervention
PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinson Disease)
Time frame: Directly after the intervention, eight weeks after inclusion
PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinsons Disease)
Time frame: At follow-up visit 3 months after the end of the intervention
Compliance
Time frame: Directly after the intervention, eight weeks after inclusion
PHQ-9 (Patient health questionnaire 9)
Time frame: Directly after the intervention, eight weeks after inclusion
PHQ-9 (Patient health questionnaire 9)
Time frame: At follow-up visit 3 months after the end of the intervention
2) visual analogue scale (1-10)
Time frame: Directly after the intervention, eight weeks after inclusion
Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)
Time frame: Directly after the intervention, eight weeks after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 41857604Svaerke K, Christensen L, Lokkegaard A, Kjaergaard J, Jacobsen JC, Engelter S, Modrau B, Quinn T, Traenka C, Sunnerhagen KS, Christensen H. The COMPEX-trial: computer-based cognitive rehabilitation to improve executive function versus unspecific training in patients after stroke, cardiac arrest or in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2026 Mar 19;27(1):310. doi: 10.1186/s13063-026-09623-5.
- Individual participant dataSharing planned: Undecided. This is currently undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Christensen, Professor principal investigator
Bispebjerg Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based cognitive rehabilitation (CBCR) and General computer-based cognitive stimulation in people with Parkinson Disease and Stroke, run by Bispebjerg Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CABPad Working Memory Test (time frame: After the end of the intervention (8 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04229056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.