Mild TBI Assessment & Rehabilitation

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Sep 28, 2016

Keywords

ClinConnect Summary

This clinical trial, called "Mild TBI Assessment & Rehabilitation," is focused on helping Veterans who have experienced mild traumatic brain injuries (mTBI) and may also face emotional challenges. The study aims to find out if training that helps improve attention and self-control through activities that matter personally to the Veterans can make their daily lives better. Researchers will look at whether this training leads to real improvements in thinking and behavior, as well as how it affects the brain areas involved in these functions.

To participate in this study, Veterans must be at least 18 years old and have a history of mild TBI, confirmed by medical records. Participants will need to show they have some ongoing cognitive difficulties that affect their daily life. The study welcomes all genders and does not limit participation based on race or income. Participants can expect to engage in training sessions and assessments, and they will be closely monitored throughout the study. Importantly, this research could help pave the way for future studies aimed at understanding how to best support Veterans with brain injuries and enhance their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• For TBI-positive veteran participants, to be randomized to either GOALS or TAU:
• • Ages 18+
• • A history of mild TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument)
• • Chronic, stable phase of recovery (\>6 months from last post-concussive event)
• • Report of residual cognitive difficulties (1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI)) that interfere(s) with daily function
• • Able and willing to commit to participate in training and assessments
• • If on psychoactive medications, must be stable on medications (\> 30 days)
• For the TBI-negative healthy veteran control group:
• • Ages 18+
• • No history of any (mild to severe) TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument)
• • Able and willing to commit to participate in assessments
• • If on psychoactive medications, must be stable on medications (\> 30 days)
• Exclusion Criteria:
• For the TBI-positive veteran participants, to be randomized to either GOALS or TAU:
• • A history of moderate or severe TBI
• • Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g., contraindications to MRI)
• • Ongoing illicit drug or alcohol abuse (AUDIT\>8)
• • Psychosis
• • Severe depression, anxiety or PTSD that precludes participation in research activities
• • Poor English comprehension
• • Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD
• • There will be no restriction in regard to gender, race and socioeconomic status
• For the TBI-negative healthy veteran control group:
• • A history of any mild, moderate, or severe TBI
• • Unstable medical, neurologic, or psychiatric condition, including severe cognitive dysfunction, or other reasons for being unable or unwilling to participate in study procedures (e.g. contraindications to MRI)
• • Ongoing illicit drug or alcohol abuse (AUDIT\>8)
• • Psychosis
• • Severe depression, anxiety or PTSD that precludes participation in research activities
• • Poor English comprehension
• • Eligible participants may have other co-morbid stable neuropscyhiatric disorders, including depression and PTSD.
• • There will be no restriction in regard to gender, race and socioeconomic status