Overview

This trial is active, not recruiting.

Condition brain injury
Treatments training in goal-directed attention regulation, brain health education, computer-assisted training in goal-directed attention regulation
Phase phase 1
Sponsor VA Office of Research and Development
Collaborator University of California, San Francisco
Start date September 2009
End date December 2015
Trial size 36 participants
Trial identifier NCT01035606, B4605-I

Summary

Brain injuries affect the lives of numerous Veterans. This study examines how the brain is affected by injury and how rehabilitation training for attention dysfunction may change brain functioning.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
training in goal-directed attention regulation
training in goal-directed attention regulation
training in goal-directed attention regulation
(Active Comparator)
brain health education
brain health education
brain health education workshops
(Experimental)
computer-assisted training in goal-directed attention regulation
computer-assisted training in goal-directed attention regulation
computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills

Primary Outcomes

Measure
Self-report
time frame: 5 weeks

Secondary Outcomes

Measure
functional performance in real world setting
time frame: 5 weeks
performance on neuropsychological testing
time frame: 5 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - history of traumatic brain injury - greater than 1 week from injury - residual dysfunction related to attention and executive control Exclusion Criteria: - aphasia - active illicit drug use - severe depression - contraindications to MRI scanning

Additional Information

Official title Plasticity in Brain Network to Enhance Cognitive Rehabilitation
Principal investigator Mark D'Esposito, MD
Description Traumatic brain injuries (TBI) are a leading cause of long-term disability among combat Veterans. The most common and persistent sequelae after TBI are cognitive-behavioral deficits in 'executive control' and 'attention' functions. Such abnormalities may directly contribute to poor long-term outcomes as well as impede rehabilitation of dysfunction in other cognitive and motor domains. Effective treatments would potentially make a major impact in improving functional outcomes, but consistently effective treatments are not available. The overall goal of this research is to improve the investigators' understanding of plasticity in brain function after TBI and to develop improved cognitive neurorehabilitation treatments. The intervention involves individual and group-based training in cognitive skills.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.