search
Back to results

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

Primary Purpose

Acquired Brain Injury, Cognitive Symptom, Executive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Computer based cognitive rehabilitation
Sham computerized gaming
Sponsored by
Katrine Sværke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Hjerneskade

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Brain+ with clinical support

Cogmed with continuous support

Brain+ without support

Sham-training group

Arm Description

Intervention: Computer based cognitive rehabilitation. This group will train with the programme 'Brain+' and receive continuous support from a clinician during the intervention period.

Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Cogmed' and receive continuous support from a clinician during the intervention period.

Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Brain+' but receive no support during the intervention period.

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.

Outcomes

Primary Outcome Measures

PASAT
Paced auditory serial addition test, test of verbal working memory
Trail making test A+B
Trail test A: Test of visual attention, trail test B: Test of visual working memory and cognitive shifts

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2018
Last Updated
July 21, 2021
Sponsor
Katrine Sværke
Collaborators
University of Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT03558308
Brief Title
CBCR for Executive Functions in Patients With ABI in the Chronic Phase
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Katrine Sværke
Collaborators
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury, Cognitive Symptom, Executive Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brain+ with clinical support
Arm Type
Experimental
Arm Description
Intervention: Computer based cognitive rehabilitation. This group will train with the programme 'Brain+' and receive continuous support from a clinician during the intervention period.
Arm Title
Cogmed with continuous support
Arm Type
Experimental
Arm Description
Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Cogmed' and receive continuous support from a clinician during the intervention period.
Arm Title
Brain+ without support
Arm Type
Experimental
Arm Description
Intervention: computer based cognitive rehabilitation. This group will train with the programme 'Brain+' but receive no support during the intervention period.
Arm Title
Sham-training group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computer based cognitive rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham computerized gaming
Intervention Description
Sham training with generally stimulating computer-games
Primary Outcome Measure Information:
Title
PASAT
Description
Paced auditory serial addition test, test of verbal working memory
Time Frame
3 seconds
Title
Trail making test A+B
Description
Trail test A: Test of visual attention, trail test B: Test of visual working memory and cognitive shifts
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
SDMT
Description
Symbol digit modalities test: Test of processing speed
Time Frame
90 seconds
Title
Word fluency test
Description
Test of verbal fluency
Time Frame
1 min
Title
Digit span (WAIS-IV)
Description
Test of verbal memory (forward) and working memory (backward)
Time Frame
5 minutes
Title
Spatial span (WMS-III)
Description
Test of visuospatial memory (forward) and visuospatial working memory (backward)
Time Frame
5 minutes
Title
Stroop colour and word test
Description
Test of inhibition
Time Frame
3 minutes
Title
BNI-FS
Description
Barrow Neurological Institute Fatigue Scale: Test of fatigue after brain injury
Time Frame
10 minutes
Title
Quality of Life after Brain Injury (QOLIBRI)
Description
Questionnaire about quality of life
Time Frame
10 minutes
Title
Wordlist, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Description
Verbal memory test
Time Frame
10 minutes

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesper Mogensen, Professor
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Hjerneskade
City
Amager
State/Province
København
ZIP/Postal Code
2300
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs