Retraining Neural Pathways Improves Cognitive Skills After A Mild Traumatic Brain Injury
The proposed study tests the feasibility (Phase I) of PATH neurotraining to improve working memory and attention in mTBI patients rapidly and effectively to provide clinical testing of a therapeutic training for the remediation of cognitive disorders caused by a concussion. This study will contribute to the fundamental knowledge of how to remediate concussions from a mTBI to enhance the health, lengthen the life and reduce the disabilities that result from a mTBI.
Conditions:
🦠 MTBI - Mild Traumatic Brain Injury
🗓️ Study Start (Actual) 1 July 2023
🗓️ Primary Completion (Estimated) 30 June 2025
✅ Study Completion (Estimated) 30 June 2025
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Diego, California, United States
📍 Solana Beach, California, United States

📋 Eligibility Criteria

Description

  • A patient with a mTBI who has had a traumatically induced physiologic disruption of brain function will be referred by neurologist Dr. Ahmed who has made a diagnosis of mTBI, which includes one or more of the following (Marshall et al., 2012):
  • 1. any loss of consciousness from 5- 30 min (not longer than 30 min),
  • 2. any loss of memory for events immediately before or after the accident for as much as 24 hours,
  • 3. any alteration of mental state at the time of the accident (e.g. feeling dazed, disoriented, or confused),
  • 4. after 30 minutes, Glasgow Coma Scale of 13-15 (not lower or is considered more severe than a mild TBI),
  • 5. post-traumatic amnesia less than 24 hours,
  • 6. a score of 19-25 on the Montreal Cognitive Assessment (MoCA) screening test,
  • 7. focal neurologic deficits that might/might not be transient,
  • 8. one or multiple concussions.
  • For this study, the following criteria will be utilized:
  • Inclusion Criteria:

    • 1. Diagnosis of mTBI (scoring between 19-25 on MoCA screening test),
    • 2. between the ages of 18 to 60 years, when development and aging are not factors,
    • 3. agrees to complete the study after hearing the time commitment involved,
    • 4. has corrected 20/20 visual acuity, so can do PATH training (dim gray stripes),
    • 5. reads English fluently, so can follow instructions, and
    • 6. can complete the PATH neurotraining task, by pushing the left or right arrow key on the computer.
    • 7. can sign and understand the informed consent form themself,
    • 8. can drive to test sites or capable of using public transportation (bus or train) to test site.

    Exclusion Criteria:

    • 1. mTBI occurred less than 3 months earlier,
    • 2. post-traumatic amnesia longer than 24 hours,
    • 3. diagnosis of epilepsy or seizure disorder in last 12 months,
    • 4. diagnosis of major depressive disorder or severe anxiety,
    • 5. answers 'Yes' to any of the questions on the Columbia Suicide Severity Rating Scale,
    • 6. had a stroke or metabolic derangements causing cognitive impairments, ie. alcohol or substance abuse,
    • 7. cannot sign and understand the informed consent form themself,
    • 8. cannot drive or use public transportation to arrive at PDI 3 times/week (MWF) for 30 minutes for 12 weeks,
    • And for those chosen to undergo MEG/MRI exams:
    • 9. has extensive metal dental hardware (e.g., braces and large metal dentures; fillings are acceptable) or other metal objects in head, neck, or face areas that cause artifacts in MEG data and health concerns in MRI data, and are not removable during pre-processing, and
    • 10. has claustrophobia since MRI scanner is in small enclosed space, or
    • 11. has a cardiac pacemaker.
Ages Eligible for Study: 18 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 29 August 2018
  • First Submitted that Met QC Criteria 29 August 2018
  • First Posted 31 August 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 July 2024
  • Last Update Posted 23 July 2024
  • Last Verified July 2024