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 to an active control condition.

Full Title of Study: “Computer-Assisted Self-Training to Improve Executive Function Versus Unspecific Training in Patients After Stroke, Cardiac Arrest or in Parkinon’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 an active control condition completing general mentally stimulating sham-training. A total of 300 patients (100 from each patient-group) is expected to be enrolled. All patients will complete a neuropsychological testbattery tageting executive functions at inclusion and after the training period. Furthermore, all patients will answer questionnaires concerning quality of life and ADL-measures before and after the intervention. All patients will train with the intervention-programme or the sham-programme for a period of 8 weeks, 5 times a week for 60 minutes.

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
    • 300 patients (200 with stroke, 50 with Parkinson’s disease and 50 with heart attack) will be allocated to specifif computer-based cognitive rehbailitation. This group will train with 11 exercises from the cognitive rehabilitation software ‘Scientific Braintraining PRO’. These 11 exercises are designed to train various executive functions.
  • Sham Comparator: General computer-based cognitive stimulation
    • 300 patients (200 with stroke, 50 with Parkinson’s disease and 50 with heart attack)will be allocated to general computer-based cognitive stimulation. This group will train with 11 generally mentally stimulating games on a sham-webside specifically dedigned for this trial. These 11 games are chosen because they are believed to have a low load on executive functions.

Clinical Trial Outcome Measures

Primary Measures

  • CABPad Working Memory Test
    • Time Frame: At follow-up visit 8 weeks after inclusion
    • Test of spatial working memory. The higher score the better (theoretically infinite score)
  • Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)
    • Time Frame: At follow-up visit 8 weeks after inclusion
    • Questionnaire concerning activities of daily living. 0-3 points on an 8-item scale, the fewer points the better.

Secondary Measures

  • CABPad Working Memory Test – 3 months follow-up after end of intervention
    • Time Frame: 3 months after follow-up visit
    • Test of spatial working memory. The higher score the better (theoretically infinite score)
  • Trail Making A
    • Time Frame: At follow-up visit 8 weeks after inclusion
    • Test of processing speed and visual attention. The lower score the better (theoretically infinite score)
  • Trail Making A
    • Time Frame: 3 months after follow-up visit
    • Test of processing speed and visual attention. The lower score the better (theoretically infinite score)
  • Trail Making B
    • Time Frame: At follow-up visit 8 weeks after inclusion
    • Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)
  • Trail Making B
    • Time Frame: 3 months after follow-up visit
    • Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)
  • SDMT
    • Time Frame: At follow-up visit 8 weeks after inclusion
    • Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)
  • SDMT
    • Time Frame: 3 months after follow-up visit
    • Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)
  • Fonological verbal fluency test
    • Time Frame: At follow-up visit 8 weeks after inclusion
    • Test of verbal fonological fluency. The higher score the better (theoretically infinite score)
  • Fonological verbal fluency test
    • Time Frame: 3 months after follow-up visit
    • Test of verbal fonological fluency. The higher score the better (theoretically infinite score)
  • Categorical verbal fluency test
    • Time Frame: At follow-up visit 8 weeks after inclusion
    • Test of verbal categorical fluency. The higher score the better (theoretically infinite score)
  • Categorical verbal fluency test
    • Time Frame: 3 months after follow-up visit
    • Test of verbal categorical fluency. The higher score the better (theoretically infinite score)
  • Fear questionnaire
    • Time Frame: At follow-up visit 8 weeks after inclusion
    • Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of a voidance due to fear
  • Fear questionnaire
    • Time Frame: 3 months after follow-up visit
    • Questionnaire with 24 items concerning fear on a scale from 0 to 8 where 8 indicates a higher degree of a voidance due to fear
  • mrs: Modified Rankin Scale
    • Time Frame: At follow-up visit 8 weeks after inclusion
    • Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead): Higher score indicates more severe diability.
  • mrs: Modified Rankin Scale
    • Time Frame: 3 months after follow-up visit
    • Questionnaire concerning disability on a scale from 0 (no symptoms) to 6 (dead). Higher score indicates more severe diability.
  • IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)
    • Time Frame: At follow-up visit 8 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 diability.
  • IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)
    • Time Frame: 3 months after follow-up visit
    • 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 diability.
  • EuroQol-5 domain (EQ-5D-5L)
    • Time Frame: At follow-up visit 8 weeks after inclusion
    • Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disiability . Higher score indicates more severe diability. Completed by patient and partner
  • EuroQol-5 domain (EQ-5D-5L)
    • Time Frame: 3 months after follow-up visit
    • Quality of life scale with 5 domains, each rated from 1-5 indicating slight to severe disiability. Higher score indicates more severe diability. Completed by patient and partner
  • PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinson Disease)
    • Time Frame: At follow-up visit 8 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 diability.
  • PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinsons Disease)
    • Time Frame: 3 months after follow-up visit
    • 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 diability.
  • Compliance
    • Time Frame: At follow-up visit 8 weeks after inclusion
    • Monitoring of total time spent training in minutes
  • PHQ-9 (Patient health questionnaire 9)
    • Time Frame: At follow-up visit 8 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 diability.
  • PHQ-9 (Patient health questionnaire 9)
    • Time Frame: 3 months after follow-up visit
    • 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 diability.
  • 2) visual analogue scale (1-10)
    • Time Frame: At follow-up visit 8 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: 3 months after follow-up visit
    • 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: t-score below 40, equivalent to 1 SD below the mean.
  • 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 [34].
  • Cognition enhancing drugs including acetylcholinesterase inhibitors, memantine, modafinil, atomoxetine, amphetamines

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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