Retraining Neural Pathways to Improve Working Memory After Mild TBI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial will assess whether PATH neurotraining followed by DigitMemory exercises can improve working memory, processing speed, and attention in adults with mild traumatic brain injury. It is a Phase II interventional study enrolling two subgroups of mTBI patients and using a structured 30-minute training protocol delivered over 36 or 54 sessions. Participants will be screened and balanced for factors like age, sex, visual working memory performance, and TBI history, with outcomes focused on cognitive remediation. The trial is designed as minimal-risk and aims to expand understanding of cortical timing-based remediation for concussion-related cognitive disorders. Recruitment will occur through clinician referrals and programmatic partnerships, targeting about 90 participants over three years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Referred by Clinician verifying that patient has an mTBI (also includes moderate TBI: those who had a severe TBI with a loss of consciousness more than 30 minutes that is now an mTBI) and has a visual working memory loss as determined by first neuropsychological pre-test administered: The Test of Information Processing Skills (TIPS),
2. One or more concussions,
3. Any loss of consciousness from 5- 30 min (not longer than 30 min) to be in mTBI group, otherwise in moderate TBI group.
4. Any loss of memory for events immediately before or after the accident for 24 hours is in mTBI group, otherwise is in moderate TBI group,
5. Any alteration of mental state at the time of the accident (e.g. feeling dazed, disoriented, or confused),
6. Be between the ages of 18 to 60 years, when development and aging are not factors,
7. Agrees to complete the study after hearing the time commitment involved,
8. Has corrected 20/20 visual acuity, and normal motor control so can do PATH neurotraining (signal direction that dim gray stripes move by pushing arrow keys on the computer),
9. Can sign and understand the informed consent form themself,
10. Can drive to test sites or capable of using public transportation (bus or train) to test site.
11. Reads English fluently, so can follow instructions.

Exclusion Criteria:

1. mTBI occurred less than 3 months earlier \[While post-concussive symptoms (PCS) resolve within days post injury in the majority of individuals with mTBI,127 symptoms can endure 3 months post injury or longer, indicating spontaneous recovery and chronic sequela.128 In the general public, between 8% to 33% of mTBI patients have persistent PCS and long-term cognitive and/or behavioral impairments129 that negatively impact quality of life. In the proposed study, we will try to minimize the confound from the spontaneous recovery by only recruiting chronic mTBI subjects, and not recruiting mTBI subjects with mTBI less than 3 months.\] with no maximum time if still experiencing memory problems which will be measured by the TIPS visual working memory (VWM) scores.
2. diagnosis of epilepsy or seizure disorder in last 12 months,
3. diagnosis of moderate depressive disorder or moderate anxiety, having driving limitations in traffic
4. answers 'Yes' to any of the questions on the Columbia Suicide Severity Rating Scale,
5. had a stroke or metabolic derangements causing cognitive impairments, i.e. alcohol or substance abuse,

   And for those chosen to undergo MEG exams:
6. 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 are not removable during pre-processing, and
7. has claustrophobia since MRI scanner is in small enclosed space,
8. has a cardiac pacemaker, or 9) is pregnant.

Where it's running

• University of California at San Diego
  San Diego, California, United States Recruiting
• Perception Dynamics Institute
  Solana Beach, California, United States Recruiting

Study contacts

• Principal investigator: Teri Lawton, Ph.D. — Perception Dynamics Institute
• Study coordinator: Teri Lawton, Ph.D.
• Email: tlawton@pathtoreading.com
• Phone: 310-903-6009

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ReVIVE for mTBI: Using VR and therapy to help adults with mild traumatic brain injury

  This study tests a virtual reality therapy combined with standard psychotherapy to see if it can reduce PTSD symptoms and improve executive function in adults with mild traumatic brain injury.

  Recruiting Phase 1 Johns Hopkins University · Baltimore, Maryland · NCT07890337

• Group-based Emotional Awareness and Expression Therapy to Support Recovery After Acquired Brain Injury

  A group therapy program based on EAET is tested to see if it helps adults 18-65 with acquired brain injury improve emotional well-being and daily functioning.

  Recruiting Uppsala University · Uppsala · NCT07852936

• BCAAs in Concussion: a higher-dose test in teens and young adults

  This trial will test whether high-dose branched-chain amino acids help teens and young adults recover from concussion compared with a placebo.

  Recruiting Phase 2 Children's Hospital of Philadelphia · Havertown, Pennsylvania · NCT07670195

• Validating vision tests for concussion-related eye movement problems

  This project will test whether a set of visual endurance exams can reliably measure eye-movement problems in people 1–6 months after a mild concussion.

  Recruiting Salus University · Philadelphia, Pennsylvania · NCT07282691

• HeadPulse for detecting concussion and tracking recovery

  This project will test whether the HeadPulse device can detect concussion and track recovery in people age 4 and up who have had a mild traumatic brain injury, with a focus on athletes.

  Recruiting MindRhythm, Inc. · Cupertino, California and 1 other locations · NCT07190963

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.