Brain Injury Clinical Trial
— RDOfficial title:
Remotely Deployed Training for Cognitive Impairment Associated With TBI
Verified date | May 2018 |
Source | VA Northern California Health Care System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Injury to the brain can change the core of a person's being, affecting brain functions necessary to accomplish important goals in a complex world. Deficits in attention, working memory, and other aspects of goal-directed cognition affect a broad range of pursuits in everyday life, and are among the most prevalent and long-lasting consequences of brain injuries. The objective of this research is to develop remotely deployed training tools that target the most common, persistent and debilitating cognitive functions affected by traumatic brain injury (TBI); test the potential effects of the intervention and compare these effects to an active comparison intervention; and determine the neurocognitive and functional effects of computer-assisted remote training.
Status | Active, not recruiting |
Enrollment | 85 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Veterans with a history of traumatic brain injury - Age 24-65 - Mild residual dysfunction in executive control - In the chronic, stable phase of recovery (>6 months from injury) - On stable psychoactive medications (> 30 days) - Able and willing to participate in training and assessments. Exclusion Criteria: - Unstable medical, neurologic or psychiatric conditions - Severe cognitive dysfunction - Ongoing illicit drug or alcohol abuse - Severe depression, severe anxiety or severe PTSD precluding participation - Poor English comprehension. |
Country | Name | City | State |
---|---|---|---|
United States | VA Northern California Health Care System | Martinez | California |
United States | San Francisco VA Medical Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
VA Northern California Health Care System | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Goal Processing Scale Scores | Functional/Behavioral evaluation | Baseline, Week 6-8, Week 12-16, and Week 18-24 | |
Secondary | Change in Scores on Neuropsychological Assessment Measures | Battery of Neuropsychological Tests | Baseline, Week 6-8, Week 12-16, and Week 18-24 |
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