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

• Sponsor: Katrine Sværke (Other)
• Overall Status: Completed
• CT.gov ID: NCT03558308
• Collaborator: University of Copenhagen (Other)
• Enrollment: 72
• Location: 1
• Arms: 4
• Actual Duration (Months): 35
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acquired Brain Injury; Cognitive Symptom; Executive Dysfunction	Behavioral: Computer based cognitive rehabilitation; Other: Sham computerized gaming	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Patients know that one of the conditions is a control-condition not expected to have significant clinical effects (required by the danish scientific committee), but they don't know which treatment condition they are randomised to. The outcome assessor is blind to the group allocation of patients.
• Primary Purpose: Treatment
• Official Title: The Effects of Computer Based Cognitive Rehabilitation on Executive Functions in Patients With Acquired Brain Injury in the Chronic Phase: A Pilot Study
• Actual Study Start Date: Aug 1, 2018
• Actual Primary Completion Date: Jan 1, 2021
• Actual Study Completion Date: Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brain+ with clinical support 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; 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.
Experimental: Cogmed with continuous support 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; 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.
Experimental: Brain+ without support 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; 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.
Sham Comparator: Sham-training group 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; Sham training with generally stimulating computer-games

Outcome Measures

Primary Outcome Measures

1. PASAT [3 seconds]

   Paced auditory serial addition test, test of verbal working memory

2. Trail making test A+B [5 minutes]

   Trail test A: Test of visual attention, trail test B: Test of visual working memory and cognitive shifts

Secondary Outcome Measures

1. SDMT [90 seconds]

   Symbol digit modalities test: Test of processing speed

2. Word fluency test [1 min]

   Test of verbal fluency

3. Digit span (WAIS-IV) [5 minutes]

   Test of verbal memory (forward) and working memory (backward)

4. Spatial span (WMS-III) [5 minutes]

   Test of visuospatial memory (forward) and visuospatial working memory (backward)

5. Stroop colour and word test [3 minutes]

   Test of inhibition

6. BNI-FS [10 minutes]

   Barrow Neurological Institute Fatigue Scale: Test of fatigue after brain injury

7. Quality of Life after Brain Injury (QOLIBRI) [10 minutes]

   Questionnaire about quality of life

8. Wordlist, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [10 minutes]

   Verbal memory test

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Hjerneskade	Amager	København	Denmark	2300

Sponsors and Collaborators

• Katrine Sværke
• University of Copenhagen

Investigators

• Principal Investigator: Jesper Mogensen, Professor, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katrine Sværke, Bsc. Psychology, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT03558308
• Other Study ID Numbers: H-18006890
• First Posted: Jun 15, 2018
• Last Update Posted: Jul 22, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Injuries; Neurobehavioral Manifestations

Study Results

No Results Posted as of Jul 22, 2021