COMPuter-assisted Self-training to Improve EXecutive Function

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

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 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.

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 general cognitive stimulation, which is designed to provide general computer-based cognitive stimulation.

Primary outcome measures

• CABPad Working Memory Test [Time frame: After the end of the intervention (8 weeks after baseline)]

Secondary outcome measures (12)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Denmark · 2 centers

• Bispebjerg Hospital — Copenhagen
• Rigshospitalet — Copenhagen

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):3 PMID 41857604

Identifiers

NCT: NCT04229056 · H-19039236

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗