Clinical trial NCT04229056: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Stroke
Cardiac Arrest
Cognitive Dysfunction
Executive Dysfunction
Keywords: parkinson disease
stroke
cardiac arrest
executive dysfunction
cognitive dysfunction
computer-based cognitive rehabilitation
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: University of Glasgow
name: University of Basel
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: Hjernesagen
name: Göteborg University
name: Aalborg University Hospital
name: Neurorehabilitering - Kbh, City of Copenhagen
First posted: 2020-01-14
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel groups will be included in this study
Primary purpose: TREATMENT

Brief 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

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.

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

Primary outcomes:
measure: CABPad Working Memory Test
timeFrame: After the end of the intervention (8 weeks after baseline)
Secondary outcomes:
measure: CABPad Working Memory Test - 3 months follow-up
timeFrame: At follow-up visit 3 months after end of intervention
measure: Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: Trail Making A
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: Trail Making A
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: Trail Making B
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: Trail Making B
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: SDMT
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: SDMT
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: Phonological verbal fluency test
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: Phonological verbal fluency test
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: Categorical verbal fluency test
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: Categorical verbal fluency test
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: Fear questionnaire
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: Fear questionnaire
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: mrs: Modified Rankin Scale
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: mrs: Modified Rankin Scale
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: EuroQol-5 domain (EQ-5D-5L)
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: EuroQol-5 domain (EQ-5D-5L)
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinson Disease)
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinsons Disease)
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: Compliance
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: PHQ-9 (Patient health questionnaire 9)
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: PHQ-9 (Patient health questionnaire 9)
timeFrame: At follow-up visit 3 months after the end of the intervention
measure: 2) visual analogue scale (1-10)
timeFrame: Directly after the intervention, eight weeks after inclusion
measure: Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)
timeFrame: Directly after the intervention, eight weeks after inclusion
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Bispebjerg Hospital
name: Hanne Christensen, Professor
role: PRINCIPAL_INVESTIGATOR
References: