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Computer-based Attention Training in Patients With Acquired Brain Injury

Primary Purpose

Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
N-back
Visual Search
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring Cognitive training, Cognitive rehabilitation, Acquired brain injury, N-back, Visual Search, Cognitive transfer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • subjects should be able to do both task at level at the time of recruitment
  • Informed consent
  • (for brain injured patients) training must not interfere with treatment as usual.
  • (for brain injured patients) no symptoms which hinder testing and training. I.e. aphasia, deafness, tetraplegia etc.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Patient N-back

    Patient Visual Search

    Non-impaired N-back

    Non-impaired Visual Search

    Arm Description

    Patients training the N-back task

    Patients training the Visual-Search task

    Non-impaired training the N-back task

    Non-impaired training the Visual-Search task

    Outcomes

    Primary Outcome Measures

    Change from baseline Raven's advanced progressive matrices at the end of training

    Secondary Outcome Measures

    Change from baseline WAIS-III Working Memory Index at the end of training
    Change from baseline WAIS-III Processing Speed Index at the end of training
    Change from baseline Operation Span at the end of training
    Change from baseline Stroop color-text interference at the end of training
    Change from baseline AMPS at the end of training

    Full Information

    First Posted
    March 11, 2015
    Last Updated
    March 20, 2015
    Sponsor
    University of Aarhus
    Collaborators
    Regionshospitalet Hammel Neurocenter
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02399293
    Brief Title
    Computer-based Attention Training in Patients With Acquired Brain Injury
    Official Title
    Computer-based Attention Training in Patients With Acquired Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Aarhus
    Collaborators
    Regionshospitalet Hammel Neurocenter

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Investigates computer based cognitive rehabilitation and training using the N-back task with a Visual Search task as an active control. The overall purpose is to provide (further) evidence about the efficacy (or lack of efficacy) of the N-back task and to find points of convergence and divergence between patients with acquired brain injury and non-impaired subjects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Injuries
    Keywords
    Cognitive training, Cognitive rehabilitation, Acquired brain injury, N-back, Visual Search, Cognitive transfer

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Patient N-back
    Arm Type
    Experimental
    Arm Description
    Patients training the N-back task
    Arm Title
    Patient Visual Search
    Arm Type
    Active Comparator
    Arm Description
    Patients training the Visual-Search task
    Arm Title
    Non-impaired N-back
    Arm Type
    Experimental
    Arm Description
    Non-impaired training the N-back task
    Arm Title
    Non-impaired Visual Search
    Arm Type
    Active Comparator
    Arm Description
    Non-impaired training the Visual-Search task
    Intervention Type
    Behavioral
    Intervention Name(s)
    N-back
    Intervention Description
    The N-back task required patients to monitor a continuous sequence of stimuli (in this experiment audio and visual stimuli). Press a button if the current stimulus is the same as that shown N back in the sequence. N increases if performance is good and decreases if performance is poor. Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Visual Search
    Intervention Description
    The Visual Search task consists of a NxN array of shapes. Press the button if a certain target stimulus is present in this array. N increases if performance is good and decreases if performance is poor. Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day.
    Primary Outcome Measure Information:
    Title
    Change from baseline Raven's advanced progressive matrices at the end of training
    Time Frame
    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
    Secondary Outcome Measure Information:
    Title
    Change from baseline WAIS-III Working Memory Index at the end of training
    Time Frame
    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
    Title
    Change from baseline WAIS-III Processing Speed Index at the end of training
    Time Frame
    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
    Title
    Change from baseline Operation Span at the end of training
    Time Frame
    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
    Title
    Change from baseline Stroop color-text interference at the end of training
    Time Frame
    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
    Title
    Change from baseline AMPS at the end of training
    Time Frame
    within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: subjects should be able to do both task at level at the time of recruitment Informed consent (for brain injured patients) training must not interfere with treatment as usual. (for brain injured patients) no symptoms which hinder testing and training. I.e. aphasia, deafness, tetraplegia etc.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jonas Lindeløv, M.Sc.
    Organizational Affiliation
    Hammel Neurocenter
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Computer-based Attention Training in Patients With Acquired Brain Injury

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