Computer-based Attention Training in Patients With Acquired Brain Injury
1 other identifier
interventional
78
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2013
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
Study Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 11, 2015
CompletedFirst Posted
Study publicly available on registry
March 26, 2015
CompletedMarch 26, 2015
March 1, 2015
10 months
March 11, 2015
March 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline Raven's advanced progressive matrices at the end of training
within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Secondary Outcomes (5)
Change from baseline WAIS-III Working Memory Index at the end of training
within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline WAIS-III Processing Speed Index at the end of training
within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline Operation Span at the end of training
within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline Stroop color-text interference at the end of training
within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Change from baseline AMPS at the end of training
within five days after 20 full training days has been completed. Expected 3-6 weeks after baseline.
Study Arms (4)
Patient N-back
EXPERIMENTALPatients training the N-back task
Patient Visual Search
ACTIVE COMPARATORPatients training the Visual-Search task
Non-impaired N-back
EXPERIMENTALNon-impaired training the N-back task
Non-impaired Visual Search
ACTIVE COMPARATORNon-impaired training the Visual-Search task
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Regionshospitalet Hammel Neurocentercollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonas Lindeløv, M.Sc.
Hammel Neurocenter
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.sc.
Study Record Dates
First Submitted
March 11, 2015
First Posted
March 26, 2015
Study Start
April 1, 2013
Primary Completion
February 1, 2014
Study Completion
September 1, 2014
Last Updated
March 26, 2015
Record last verified: 2015-03