Computer-based Attention Training in Patients With Acquired Brain Injury

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries
• Intervention / Treatment: Behavioral: N-back; Behavioral: Visual Search

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient N-back; Patients training the N-back task	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.
Active Comparator: Patient Visual Search; Patients training the Visual-Search task	Behavioral: 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.
Experimental: Non-impaired N-back; Non-impaired training the N-back task	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.
Active Comparator: Non-impaired Visual Search; Non-impaired training the Visual-Search task	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Regionshospitalet Hammel Neurocenter
• Investigators: Principal Investigator: Jonas Lindeløv, M.Sc., Hammel Neurocenter

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: March 20, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 20, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Acquired brain injury; Cognitive training; Cognitive rehabilitation; N-back; Visual Search; Cognitive transfer
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: hnrc_nback