Retraining Neural Pathways Improves Cognitive Skills After A Mild Traumatic Brain Injury (NCT03655782) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Retraining Neural Pathways Improves Cognitive Skills After A Mild Traumatic Brain Injury
United States90 participantsStarted 2023-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Visual Working Memory
Timeframe: Immediately before begin intervention and 3, 6, and 12 months later.
. 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),
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,
. 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,