Recruiting

PATH Neurotraining

Sponsor:

Perception Dynamics Institute

Code:

NCT03655782

Conditions

MTBI - Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

PATH + DigitMemory (DM) neurotraining

Study Details

Brief summary:

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.

Conditions

MTBI - Mild Traumatic Brain Injury

Study ID

NCT03655782

Start date

Oct 5, 2026

Status verified date

Oct, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Jul 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PATH+DM neurotraining three times a week for 36 30-minute sessions

Subject looks at computer screen to determine whether dim gray stripes in fish-shaped window move left or right relative to gray stationary background stripes. The subject reports which way center stripes move by pushing left or right arrow key, receiving brief tone if incorrect. Program adaptively changes the contrast of the test pattern in order to keep subject at 79% correct. There are levels of difficulty introduced by making the background pattern more similar to that in fish, by increasing pattern's complexity level, having 16 complexity levels, and by increasing number of directions of movement from one to two directions of motion. Intervention will be trained for 20 minutes, followed by 10 minutes of digit memory exercises 3 times each week for 12 weeks. Ten minutes of digit memory (DM) practice, recalling the correct sequence of digits, each presented for 500 msec, from 5 digits up to 10 digits will be completed for 10 minutes following 20-minutes of PATH neurotraining.

experimental: PATH+DM neurotraining two times a week for 36 30-minute sessions

Subject looks at computer screen to determine whether dim gray stripes in fish-shaped window move left or right relative to gray stationary background stripes. The subject reports which way center stripes move by pushing left or right arrow key, receiving brief tone if incorrect. Program adaptively changes the contrast of the test pattern in order to keep subject at 79% correct. There are levels of difficulty introduced by making the background pattern more similar to that in fish, by increasing pattern's complexity level, having 16 complexity levels, and by increasing number of directions of movement from one to two directions of motion. Intervention will be trained for 20 minutes, followed by 10 minutes of digit memory exercises 2 times each week for 18 weeks. Ten minutes of digit memory (DM) practice, recalling the correct sequence of digits, each presented for 500 msec, from 5 digits up to 10 digits will be completed for 10 minutes following 20-minutes of PATH neurotraining.

experimental: PATH+DM neurotraining once a week for 36 30-minute sessions

Subject looks at computer screen to determine whether dim gray stripes in fish-shaped window move left or right relative to gray stationary background stripes. The subject reports which way center stripes move by pushing left or right arrow key, receiving brief tone if incorrect. Program adaptively changes the contrast of the test pattern in order to keep subject at 79% correct. There are levels of difficulty introduced by making the background pattern more similar to that in fish, by increasing pattern's complexity level, having 16 complexity levels, and by increasing number of directions of movement from one to two directions of motion. Intervention will be trained for 20 minutes, followed by 10 minutes of digit memory exercises once a week for 36 weeks. Ten minutes of digit memory (DM) practice, recalling the correct sequence of digits, each presented for 500 msec, from 5 digits up to 10 digits will be completed for 10 minutes following 20-minutes of PATH neurotraining.

experimental: Experimental: PATH+DM neurotraining three times a week for 54 30-minute sessions

Arm Description: Subject looks at computer screen to determine whether dim gray stripes in fish-shaped window move left or right relative to gray stationary background stripes. The subject reports which way center stripes move by pushing left or right arrow key, receiving brief tone if incorrect. Program adaptively changes the contrast of the test pattern in order to keep subject at 79% correct. There are levels of difficulty introduced by making the background pattern more similar to that in fish, by increasing pattern's complexity level, having 24 complexity levels, and by increasing number of directions of movement from one to two directions of motion. Intervention will be trained for 20 minutes, followed by 10 minutes of digit memory exercises 3 times each week for 18 weeks. Ten minutes of digit memory (DM) practice, recalling the correct sequence of digits, each presented for 500 msec, from 5 up to 10 digits will be completed for 10 minutes following 20-minutes of PATH training.

Interventions

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 measure

  • Change in Visual Working Memory [ Time Frame: Immediately before begin intervention and 3, 6, and 12 months later. ]

Central Contacts and Locations

Central contacts

Teri Lawton, Ph.D.

310-903-6009tlawton@pathtoreading.com

Locations

University of California at San Diego

Recruiting

San Diego, California, United States, 92121

Principal Investigator:

Ming-Xiong Huang, PhD

Perception Dynamics Institute

Recruiting

Solana Beach, California, United States, 92075

Contacts

Teri Lawton, Ph.D.

310-903-6009tlawton@pathtoreading.com

Principal Investigator:

Teri Lawton, Ph.D.

More Information

Sponsor

Perception Dynamics Institute

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Keywords

  • Improve working memory after a TBI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Perception Dynamics Institute on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.