COMPuter-assisted Self-training to Improve EXecutive Function (COMPEX)

Bispebjerg Hospital

Status: Enrolling

Conditions: Stroke; Parkinson Disease; Cognitive Dysfunction; Executive Dysfunction; Cardiac Arrest

Treatments: Behavioral: General computer-based cognitive stimulation; Behavioral: Computer-based cognitive rehabilitation (CBCR)

Study type: Interventional

Funder types: Other

Identifiers

NCT04229056

H-19039236

Details and patient eligibility

About

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

Full 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.

Enrollment: 307 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

307 participants in 2 patient groups

Specific computer-based cognitive rehabilitation

Experimental group

Description:

154 patients 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.

Treatment:

Behavioral: Computer-based cognitive rehabilitation (CBCR)

General computer-based cognitive stimulation

Active Comparator group

Description:

154 patients 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.

Treatment:

Behavioral: General computer-based cognitive stimulation