NCT03655782 · Perception Dynamics Institute
Retraining Neural Pathways Improves Cognitive Skills After A Mild Traumatic Brain Injury
What this study is about
The proposed study tests the effectiveness (Phase II) of 36 or 54 30-minute training sessions of PATH neurotraining followed by digit memory exercises to improve working memory, processing speed 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.
View original scientific description
The proposed study tests the efficacy (Phase II) of 36 or 54 30-minute training sessions of PATH neurotraining followed by digit memory exercises to improve working memory, processing speed 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.
Interventions
BEHAVIORAL
PATH + DigitMemory (DM) neurotraining
Improve visual timing and sensitivity in the dorsal stream. The mTBI subject will sit 57 cm in front of a computer monitor. During the presentation, the bars in the 'fish-shaped' window in the center of the screen formed by a sinusoidal grating, move left or right very briefly. When the screen goes blank, the subject reports which way the center pattern moved by pushing the left or right arrow key. A brief tone is presented after incorrect responses. The program adaptively changes the contrast of the test pattern so that the subject detects motion at lowest contrast possible. A sequence of patterns in each training cycle that are designed to optimally activate magnocellular neurons are shown to the subject. There are two programs, the first measures the contrast needed to see one direction of movement, and the second program measures the contrast needed to see two directions of movement, requiring memory. Both are followed by digit memory exercises.
Primary outcome measures
Change in Visual Working Memory
Time frame: Immediately before begin intervention and 3, 6, and 12 months later.
Visual Working Memory (VWM) using Test of Information Processing Skills (TIPS), having two distractor tasks to measure Sequential Processing: the subject must remember a sequence of letters, that are shown one at a time for 2 seconds each, for sequences of from 2 up to 9 letters right after seeing the entire sequence of letters. Short Term that are shown one at a time for 2 seconds each, for sequences of from 2 up to 9 letters right after seeing the entire sequence of letters. Short Term VWM is assessed by recalling the correct sequence of letters after counting from 1 to 10 numbers in sequence, starting at different initial numbers, slowly, and after repeating a short sentence with an animal subject for VWM. Delayed Recall is assessed by remembering all animal names in repeated sentences 3 minutes after finish the VWM tests. The TIPS VWM Standardized Percentile Rank goes from \<1% to 99%.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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),
- One or more concussions,
- Any loss of consciousness from 5- 30 min (not longer than 30 min) to be in mTBI group, otherwise in moderate TBI group.
- 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,
- Any alteration of mental state at the time of the accident (e.g. feeling dazed, disoriented, or confused),
- Be between the ages of 18 to 60 years, when development and aging are not factors,
- Agrees to complete the study after hearing the time commitment involved,
- 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),
- Can sign and understand the informed consent form themself,
- Can drive to test sites or capable of using public transportation (bus or train) to test site.
- Reads English fluently, so can follow instructions.
Exclusion criteria
- 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.
- diagnosis of epilepsy or seizure disorder in last 12 months,
- diagnosis of moderate depressive disorder or moderate anxiety, having driving limitations in traffic
- answers 'Yes' to any of the questions on the Columbia Suicide Severity Rating Scale,
- had a stroke or metabolic derangements causing cognitive impairments, i.e. alcohol or substance abuse, And for those chosen to undergo MEG exams:
- 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
- has claustrophobia since MRI scanner is in small enclosed space,
- has a cardiac pacemaker, or 9) is pregnant.
Where
- San Diego, California
- Solana Beach, California
Collaborators
University of California, San Diego
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2026 · Source of record for eligibility and locations