CBCR for Executive Functions in Patients With ABI in the Chronic Phase

Study Overview
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Brief Summary
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This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury

Detailed Description
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This study examines the effects of computerbased cognitive rehabilitation on executive functions in the chronic phase after acquired brain injury using two clinically developed programmes and one sham-intervention. Furthermore, the study consists of Groups that receives the computerized training both with and witouth support from a professional.

Official Title
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The Effects of Computer Based Cognitive Rehabilitation on Executive Functions in Patients With Acquired Brain Injury in the Chronic Phase: A Pilot Study

Conditions
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Acquired Brain Injury, Cognitive Symptom, Executive Dysfunction

Intervention / Treatment
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* Behavioral: Computer based cognitive rehabilitation
* Other: Sham computerized gaming


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons who are able to give an informed consent both verbally and in writing Persons in the chronic phase after stroke or traumatic brain injury (more than one year post onset) Persons who score less than the 30. Percentile in one or more of the primary outcome measures outlined above. Exclusion Criteria: Persons with neurodegenerative diseases Persons with diseases which can influence executive functions such as ADHD Persons who are motorically or cognitively unable to use a tablet and complete the CBCR-training
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain+ with clinical support<br>Intervention: Computer based cognitive rehabilitation. This group will train with the programme 'Brain+' and receive continuous support from a clinician during the intervention period. | Behavioral: Computer based cognitive rehabilitation<br>* Computer based cognitive rehabilitation is a supplementary computerized tool for cognitive rehabilitation design to train various cognitive functions. Many programmes are available. The current study investigates the effects on two such programmes on rehabilitation of executive functions in the chronic phase after acquired brain injury.<br>|
| Experimental: Cogmed with continuous support<br>Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Cogmed' and receive continuous support from a clinician during the intervention period. | Behavioral: Computer based cognitive rehabilitation<br>* Computer based cognitive rehabilitation is a supplementary computerized tool for cognitive rehabilitation design to train various cognitive functions. Many programmes are available. The current study investigates the effects on two such programmes on rehabilitation of executive functions in the chronic phase after acquired brain injury.<br>|
| Experimental: Brain+ without support<br>Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Brain+' but receive no support during the intervention period. | Behavioral: Computer based cognitive rehabilitation<br>* Computer based cognitive rehabilitation is a supplementary computerized tool for cognitive rehabilitation design to train various cognitive functions. Many programmes are available. The current study investigates the effects on two such programmes on rehabilitation of executive functions in the chronic phase after acquired brain injury.<br>|
| Sham Comparator: Sham-training group<br>Intervention: Sham computerized gaming. This group will train computerized solitaire and other computerized games which are thought to be generally cognitive stimulating but with a very limit load on executive functions. This group will receive continuous support during the intervention period. | Other: Sham computerized gaming<br>* Sham training with generally stimulating computer-games<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASAT | Paced auditory serial addition test, test of verbal working memory | 3 seconds | 
| Trail making test A+B | Trail test A: Test of visual attention, trail test B: Test of visual working memory and cognitive shifts | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SDMT | Symbol digit modalities test: Test of processing speed | 90 seconds | 
| Word fluency test | Test of verbal fluency | 1 min | 
| Digit span (WAIS-IV) | Test of verbal memory (forward) and working memory (backward) | 5 minutes | 
| Spatial span (WMS-III) | Test of visuospatial memory (forward) and visuospatial working memory (backward) | 5 minutes | 
| Stroop colour and word test | Test of inhibition | 3 minutes | 
| BNI-FS | Barrow Neurological Institute Fatigue Scale: Test of fatigue after brain injury | 10 minutes | 
| Quality of Life after Brain Injury (QOLIBRI) | Questionnaire about quality of life | 10 minutes | 
| Wordlist, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Verbal memory test | 10 minutes |