Clinical Trials Directory

Trials / Completed

CompletedNCT01120756

Neural Bases of Cognitive Rehabilitation for Brain Injury

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

Some of the most common and disabling consequences of brain injury are deficits in cognition, such as difficulty with sustained attention, memory, organization, and goal management. The long-term goal of this research program is to develop and test novel neuroscience-based cognitive interventions for improving attentional regulation and related "executive function" brain processes involved in goal-directed behavior.

Detailed description

Brain injury often results in a disruption of attention regulation processes, which reduces the efficiency and effectiveness of cognitive functions including learning, memory, problem-solving and goal management, leading to significant functional disability. More intervention options are needed. We set out to test different possible interventions. Individuals with traumatic brain injury (TBI) and chronic executive control dysfunction participate in interventions, with pre- and post-intervention measurements of cognitive functioning. Training in Goal-oriented attentional self-regulation (GOALS) was administered in comparison to Brain Health Education (EDU). GOALS is designed to train attention regulation skills along with meta-cognitive strategies for goal management, with a emphasis on application to participant-selected projects. This is a group-based intervention. Brain Health Education is designed to increase knowledge and understanding of key factors that affect brain functioning. This is a group-based intervention matched to the GOALS intervention.

Conditions

Interventions

TypeNameDescription
BEHAVIORALGoal-oriented attentional self-regulationThis will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice.
BEHAVIORALBrain Health EducationBrain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework.

Timeline

Start date
2011-10-01
Primary completion
2018-05-30
Completion
2018-12-29
First posted
2010-05-11
Last updated
2019-08-02
Results posted
2019-08-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01120756. Inclusion in this directory is not an endorsement.