- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01120756
Neural Bases of Cognitive Rehabilitation for Brain Injury
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Martinez, California, United States, 94553
- Martinez Outpatient Clinic and Community Living Center, Martinez, CA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with a history of TBI (reported plausible mechanism of head injury, loss of consciousness with some period of post-traumatic alteration in cognition) who are > 6 months post-injury will be screened for evidence of mild-moderate residual dysfunction in executive control functions based on corroborated reports of real-world difficulties (Mayo-Portland Adaptability Inventory).
Exclusion Criteria:
- Severely apathetic/abulic
- aphasic
- or other reasons for patients being unable or unwilling to participate with the training tasks
- severe cognitive dysfunction
- history of neurodevelopmental abnormalities
- ongoing illicit drug or alcohol abuse (AUDIT>8)
- severe depression as measured by Beck Depression Inventory (>29)
- severe PTSD precluding participation in research activities (such as group training or MRI scanning)
- There will be no restriction in regard to gender, race and socioeconomic status.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Goal-oriented attentional self-regulation training
Goal-oriented attentional self-regulation training (GOALS).
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This 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.
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Active Comparator: Brain Health Education
Brain Health Education (EDU)
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Brain 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions
Time Frame: Baseline, Within 2-3 weeks Post-intervention
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We computed a composite measure based upon the average of individuals' scores on commonly used neuropsychological tests of attention, working memory, and executive functions.
To compute this composite score, we first scored individual performances on each neuropsychological measure utilizing published norms, adjusted for, when available, age, gender, ethnicity, and education levels.
We then converted all resultant scores (e.g., T-scores, Standard Scores) to a common metric, z-scores.
(Z-scores are a standardized unit of measurement, scaled in terms of standard deviation (SD) units.
Thus, a z-score of 0 represents the mean; a z-score of 1 represents+1 SD above the mean; and a z-score of -1 represents -1 SD below the mean.)
Finally, for each participant, z-scores derived from each separate neuropsychological test were averaged together to yield a final composite score.
The composite score was the unit of analysis.
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Baseline, Within 2-3 weeks Post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Evaluations: Change From Baseline on the Goal Processing Scale
Time Frame: Baseline, 2-3 Weeks Post-intervention
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Observed measures of functional performance on complex tasks were assessed for the GOALS and Brain Health Education study.
The overall composite score comprises scores for planning, initiation, self-monitoring, maintenance of attention, sequencing and switching, divergent thinking, execution, learning and memory.
Scores range from 1-10.
Changes were calculated from pre-to post-training, and higher scores indicate improvement in functioning.
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Baseline, 2-3 Weeks Post-intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anthony Chen, MD MA, Martinez Outpatient Clinic, Martinez, CA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B7467-I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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