COMPuter-assisted Self-training to Improve EXecutive Function

Stroke Clinical Trial

— COMPEX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04229056
• Other study ID #: H-19039236
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Bispebjerg Hospital
• Contact: Hanne Christensen, Professor
• Phone: +45 38 63 50 70
• Email: hanne.krarup.christensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 generally cognitively stimulating activities on a computer

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Cognitive Dysfunction
• Executive Dysfunction
• Heart Arrest
• Parkinson Disease
• Stroke

Intervention

Behavioral:
• Computer-based cognitive rehabilitation (CBCR)
CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.
• 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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Rigshospitalet	Copenhagen

Sponsors (7)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Copenhagen Trial Unit, Center for Clinical Intervention Research, Göteborg University, Hjernesagen, Rigshospitalet, Denmark, University of Basel, University of Glasgow

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)	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
Primary	CABPad Working Memory Test	Test of spatial working memory. The higher score the better (theoretically infinite score)	At follow-up visit 3 months after the end of the intervention
Secondary	CABPad Working Memory Test - 3 months follow-up after end of intervention	Test of spatial working memory. The higher score the better (theoretically infinite score)	Directly after the intervention, eight weeks after inclusion
Secondary	Trail Making A	Test of processing speed and visual attention. The lower score the better (theoretically infinite score)	Directly after the intervention, eight weeks after inclusion
Secondary	Trail Making A	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
Secondary	Trail Making B	Test of divided attention, mental flexibility. The lower score the better (theoretically infinite score)	Directly after the intervention, eight weeks after inclusion
Secondary	Trail Making B	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
Secondary	SDMT	Symbol Digit Modalities Test: Test of mental speed. The higher score the better (theoretically infinite score)	Directly after the intervention, eight weeks after inclusion
Secondary	SDMT	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
Secondary	Phonological verbal fluency test	Test of verbal phonological fluency. The higher score the better (theoretically infinite score)	Directly after the intervention, eight weeks after inclusion
Secondary	Phonological verbal fluency test	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
Secondary	Categorical verbal fluency test	Test of verbal categorical fluency. The higher score the better (theoretically infinite score)	Directly after the intervention, eight weeks after inclusion
Secondary	Categorical verbal fluency test	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
Secondary	Fear questionnaire	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
Secondary	Fear questionnaire	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
Secondary	mrs: Modified Rankin Scale	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
Secondary	mrs: Modified Rankin Scale	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
Secondary	IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)	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
Secondary	IQCODE (Informant Questionnaire on Cognitive Decline in the Elderly)	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
Secondary	EuroQol-5 domain (EQ-5D-5L)	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
Secondary	EuroQol-5 domain (EQ-5D-5L)	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
Secondary	PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinson Disease)	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
Secondary	PDQ 39 (Parkinsons Disease Questionnaire: Only in patients with Parkinsons Disease)	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
Secondary	Compliance	Monitoring of total time spent training in minutes	Directly after the intervention, eight weeks after inclusion
Secondary	PHQ-9 (Patient health questionnaire 9)	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
Secondary	PHQ-9 (Patient health questionnaire 9)	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
Secondary	2) visual analogue scale (1-10)	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
Secondary	Minimum Data Set-Home Care- Instrumental Activities of Daily Living (MDS-HC-IADL)	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