ACTIVE_NOT_RECRUITING

Mild TBI Assessment & Rehabilitation

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Conditions

Brain Injuries, TraumaticRehabilitationFunctional Magnetic Resonance Imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive/behavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.

Official Title

Multi-Level Assessment and Rehabilitation of Combat Mild TBI

Quick Facts

Study Start:2017-03-09
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT02920788

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ages 18+
  2. * A history of mild TBI (as defined by DOD / VA; confirmed by medical records and in person Ohio State University TBI Instrument)
  3. * Chronic, stable phase of recovery (\>6 months from last post-concussive event)
  4. * Report of residual cognitive difficulties (1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI)) that interfere(s) with daily function
  5. * Able and willing to commit to participate in training and assessments
  6. * If on psychoactive medications, must be stable on medications (\> 30 days)
  7. * Ages 18+
  8. * 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)
  9. * Able and willing to commit to participate in assessments
  10. * If on psychoactive medications, must be stable on medications (\> 30 days)
  1. * A history of moderate or severe TBI
  2. * 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)
  3. * Ongoing illicit drug or alcohol abuse (AUDIT\>8)
  4. * Psychosis
  5. * Severe depression, anxiety or PTSD that precludes participation in research activities
  6. * Poor English comprehension
  7. * Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD
  8. * There will be no restriction in regard to gender, race and socioeconomic status
  9. * A history of any mild, moderate, or severe TBI
  10. * 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)
  11. * Ongoing illicit drug or alcohol abuse (AUDIT\>8)
  12. * Psychosis
  13. * Severe depression, anxiety or PTSD that precludes participation in research activities
  14. * Poor English comprehension
  15. * Eligible participants may have other co-morbid stable neuropsychiatric disorders, including depression and PTSD.
  16. * There will be no restriction in regard to gender, race and socioeconomic status

Contacts and Locations

Principal Investigator

Pratik Mukherjee, MD PhD
PRINCIPAL_INVESTIGATOR
San Francisco VA Medical Center, San Francisco, CA

Study Locations (Sites)

San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
United States
University of California, San Francisco
San Francisco, California, 94158
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Pratik Mukherjee, MD PhD, PRINCIPAL_INVESTIGATOR, San Francisco VA Medical Center, San Francisco, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-03-09
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2017-03-09
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • Rehabilitation
  • Functional Magnetic Resonance Imaging

Additional Relevant MeSH Terms

  • Brain Injuries, Traumatic