COMPuter-assisted Self-training to Improve EXecutive Function

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 28, 2024

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.

Interventions

  • Behavioral: Computer-based cognitive rehabilitation (CBCR)
    • CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.
  • Behavioral: General computer-based cognitive stimulation
    • For this trial we have developed a webpage for cognitive sham-training, which is designed to provide general computer-based cognitive stimulation.

Arms, Groups and Cohorts

  • Experimental: Specific computer-based cognitive rehabilitation
    • 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.
  • Active Comparator: General computer-based cognitive stimulation
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • CABPad Working Memory Test
    • Time Frame: At follow-up visit 3 months after the end of the intervention
    • Test of spatial working memory. The higher score the better (theoretically infinite score)

Secondary Measures

  • CABPad Working Memory Test – 3 months follow-up after end of intervention
    • Time Frame: Directly after the intervention, eight weeks after inclusion
    • Test of spatial working memory. The higher score the better (theoretically infinite score)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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.
  • 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.
  • Compliance
    • Time Frame: Directly after the intervention, eight weeks after inclusion
    • Monitoring of total time spent training in minutes
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bispebjerg Hospital
  • Collaborator
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hanne Christensen, Professor – Bispebjerg Hospital
  • Overall Official(s)
    • Hanne Christensen, Professor, Principal Investigator, Bispebjerg Hospital
  • Overall Contact(s)
    • Hanne Christensen, Professor, +45 38 63 50 70, hanne.krarup.christensen@regionh.dk

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