COMPuter-assisted Self-training to Improve EXecutive Function (COMPEX)

February 19, 2025 updated by: Hanne Christensen, Bispebjerg Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
307

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
After the end of the intervention (8 weeks after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Directly after the intervention, eight weeks after inclusion
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
Time Frame: At follow-up visit 3 months after the end of the intervention
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
Time Frame: Directly after the intervention, eight weeks after inclusion
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
Time Frame: At follow-up visit 3 months after the end of the intervention
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
Time Frame: Directly after the intervention, eight weeks after inclusion
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
Time Frame: At follow-up visit 3 months after the end of the intervention
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
Time Frame: Directly after the intervention, eight weeks after inclusion
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
Time Frame: At follow-up visit 3 months after the end of the intervention
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
Time Frame: Directly after the intervention, eight weeks after inclusion
Monitoring of total time spent training in minutes
Directly after the intervention, eight weeks after inclusion
2) visual analogue scale (1-10)
Time Frame: Directly after the intervention, eight weeks after inclusion
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)
Time Frame: Directly after the intervention, eight weeks after inclusion
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
Time Frame: Directly after the intervention, eight weeks after inclusion
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
Time Frame: At follow-up visit 3 months after the end of the intervention
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
Time Frame: Directly after the intervention, eight weeks after inclusion
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
Time Frame: At follow-up visit 3 months after the end of the intervention
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
Time Frame: Directly after the intervention, eight weeks after inclusion
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
Time Frame: At follow-up visit 3 months after the end of the intervention
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)
Time Frame: Directly after the intervention, eight weeks after inclusion
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)
Time Frame: At follow-up visit 3 months after the end of the intervention
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)
Time Frame: Directly after the intervention, eight weeks after inclusion
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)
Time Frame: At follow-up visit 3 months after the end of the intervention
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)
Time Frame: Directly after the intervention, eight weeks after inclusion
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)
Time Frame: At follow-up visit 3 months after the end of the intervention
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)
Time Frame: Directly after the intervention, eight weeks after inclusion
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)
Time Frame: At follow-up visit 3 months after the end of the intervention
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
Time Frame: At follow-up visit 3 months after end of intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bispebjerg Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hanne Christensen, Professor, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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