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Completed

NCT Number: NCT03558308

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

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

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Key information

Conditions

Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Cognitive Symptom Craniocerebral Trauma Executive Dysfunction Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Hjerneskade

Amager, København, 2300, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer based cognitive rehabilitation

Behavioral

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 computerized gaming

Other

Sham training with generally stimulating computer-games

Primary outcomes

  1. PASAT

    Time frame: 3 seconds

    Paced auditory serial addition test, test of verbal working memory

  2. Trail making test A+B

    Time frame: 5 minutes

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

Secondary outcomes

  1. SDMT

    Time frame: 90 seconds

    Symbol digit modalities test: Test of processing speed

  2. Word fluency test

    Time frame: 1 min

    Test of verbal fluency

  3. Digit span (WAIS-IV)

    Time frame: 5 minutes

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

  4. Spatial span (WMS-III)

    Time frame: 5 minutes

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

  5. Stroop colour and word test

    Time frame: 3 minutes

    Test of inhibition

  6. BNI-FS

    Time frame: 10 minutes

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

  7. Quality of Life after Brain Injury (QOLIBRI)

    Time frame: 10 minutes

    Questionnaire about quality of life

  8. Wordlist, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: 10 minutes

    Verbal memory test

Sponsors and collaborators

Lead sponsor

Katrine Sværke

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2018
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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