Computer-based Attention Training in Patients With Acquired Brain Injury

Brain Injuries Clinical Trial

Official title:

Computer-based Attention Training in Patients With Acquired Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399293
• Other study ID #: hnrc_nback
• Status: Completed
• Phase: N/A
• First received: March 11, 2015
• Last updated: March 20, 2015
• Start date: April 2013
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Behavioral:
• N-back
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.
• Visual Search
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Regionshospitalet Hammel Neurocenter

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No