NCT03558308

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

June 3, 2018

Last Update Submit

July 21, 2021

Conditions

Acquired Brain InjuryCognitive SymptomExecutive Dysfunction

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • SDMT

    90 seconds

  • Word fluency test

    1 min

  • Digit span (WAIS-IV)

    5 minutes

  • Spatial span (WMS-III)

    5 minutes

  • Stroop colour and word test

    3 minutes

  • +3 more secondary outcomes

Study Arms (4)

Brain+ with clinical support

EXPERIMENTAL

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

Cogmed with continuous support

EXPERIMENTAL

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

Brain+ without support

EXPERIMENTAL

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

Sham-training group

SHAM COMPARATOR

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

Interventions

Computer based cognitive rehabilitationBEHAVIORAL

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.

Brain+ with clinical supportBrain+ without supportCogmed with continuous support
Sham computerized gamingOTHER

Sham training with generally stimulating computer-games

Sham-training group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Hjerneskade

Amager, København, 2300, Denmark

Location

MeSH Terms

Conditions

Brain InjuriesNeurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jesper Mogensen, Professor

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Bsc. Psychology

Study Record Dates

First Submitted

June 3, 2018

First Posted

June 15, 2018

Study Start

August 1, 2018

Primary Completion

January 1, 2021

Study Completion

July 1, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

DK(1)