Summary

Eligibility
for people ages 18-55 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

Mild traumatic brain injury (TBI) is a common medical condition that occurs when a head injury causes someone to lose consciousness, feel dazed or confused, or be unable to remember events occurring immediately after the injury. While most individuals with mild TBI recover within weeks or months, some individuals with mild TBI report chronic symptoms such as difficulty with cognitive skills like attention, learning, or memory, along with other symptoms such as irritability or headache. Previous studies, including those conducted by our scientific team, have shown that cognitive rehabilitation can help patients with persistent symptoms after mild TBI return to full duty, work, school, and other important life activities. Specifically, cognitive rehabilitation can provide lasting improvements in thinking abilities, functional capacity, post-concussive symptoms, and quality of life after mild TBI. However, effective interventions are still out of reach for many service members and Veterans with TBI. For patients who have returned to duty, employment, or education, scheduling up to 60 hours of treatment (a typical treatment schedule in many settings) may not be feasible. Additionally, some patients may live in areas where it is burdensome to make numerous visits to a medical center. Personalized Augmented Cognitive Training (PACT) compresses treatment into six hours of once-weekly personalized, one-on-one training by selecting treatment modules based on patient needs and priorities-substantially reducing the total amount of time required to complete treatment. PACT can be offered either in-person (in clinic) or via home-based video telemedicine, depending upon patients' preferences. Additionally, PACT includes training and encouragement for service members and Veterans to make self-directed use of mobile apps that train cognitive skills and strategies.The primary goal of this study is to evaluate whether PACT is effective at improving cognition, symptoms, and functional outcomes among military service members and Veterans with a history of mild TBI. The study will also yield information about factors that can enhance or interfere with treatment, such as number of previous TBIs, presence of post-traumatic stress; and choice of in-person vs. video telemedicine delivery of care.

Keywords

Traumatic Brain Injury cognitive rehabilitation Brain Injuries Brain Injuries, Traumatic Personalized Augmented Cognitive Training (PACT) PACT ETAU

Eligibility

You can join if…

Open to people ages 18-55

All participants:

  1. Male or female
  2. All racial and ethnic groups
  3. Ages 18 to 55
  4. Veteran or service member
  5. History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBIID method)
  6. Score of ≥4 on the cognitive subscale of the Neurobehavioral Symptom Inventory reflecting 'very severe' symptoms in at least one area or at least 'mild' symptoms in all four areas surveyed
  7. have a compatible device (computer, tablet, or smartphone) with internet connection (wifi or cellular plan).

You CAN'T join if...

  1. Mild TBI sustained < 3 months previously
  2. History of moderate, severe, or penetrating TBI
  3. History of other neurological condition unrelated to TBI
  4. Current psychiatric disturbance that would preclude study participation (e.g. clinically significant mania or psychosis)
  5. Current substance use disorder
  6. Current, active suicidal or homicidal ideation
  7. Current use of benzodiazepines or medications with anticholinergic effects
  8. Not stable on psychiatric medications for at least 6 weeks
  9. Impaired decision making capacity
  10. . Unable to provide voluntary informed consent
  11. . Previously completed >4 sessions of cognitive rehabilitation

Locations

  • VA San Diego Healthcare System accepting new patients
    San Diego California 92161 United States
  • Naval Medical Center San Diego accepting new patients
    San Diego California 92134 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Veterans Medical Research Foundation
ID
NCT04560946
Study Type
Interventional
Last Updated