Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a diagnosis of epilepsy, seizure disorder, major depressive disorder, or severe anxiety, you may not be eligible to participate.
What data supports the effectiveness of the treatment N-Back Working Memory Training for concussion?
How is PATH neurotraining treatment different from other concussion treatments?
PATH neurotraining is unique because it uses neurofeedback, a technique that helps patients train their brain responses under minimal stress, which is different from traditional rest or exercise-based concussion treatments. This approach focuses on improving brain function directly, rather than just managing symptoms or physical activity levels.678910
Research Team
TL
Teri Lawton, Ph.D.
Principal Investigator
Perception Dynamics Institute
Eligibility Criteria
This trial is for individuals aged 18-60 who have had a mild traumatic brain injury (mTBI) and score between 19-25 on the MoCA test. Participants must read English, have corrected 20/20 vision, and be able to commit time to complete the study. Those with post-traumatic amnesia over 24 hours, recent mTBI (<3 months), or certain cognitive impairments are excluded.Inclusion Criteria
Has corrected 20/20 visual acuity for PATH training
Fluent in English to follow instructions
Can sign and understand the informed consent form
See 5 more
Exclusion Criteria
I have experienced memory loss for more than a day after an injury.
Presence of extensive metal dental hardware 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
Claustrophobia or presence of a cardiac pacemaker for MEG/MRI exams.
See 7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phone screening
Treatment
Participants undergo PATH, N-Back WM, or Sham neurotraining for cognitive improvement
12 weeks
36 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Long-term
Treatment Details
Interventions
- N-Back Working Memory Training (Behavioural Intervention)
- Orientation Discrimination (Behavioural Intervention)
- PATH neurotraining (Behavioural Intervention)
Trial OverviewThe study tests PATH neurotraining's ability to improve working memory and attention in patients with mTBI. It aims to establish if this training can rapidly and effectively remediate cognitive issues caused by concussions.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: PATH neurotrainingExperimental Treatment1 Intervention
Subject looks at computer screen to determine whether dim gray stripes in fish-shaped window move left or right relative to 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 contrast of 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, and by increasing number of directions of movement from one to two directions of motion. Intervention will be trained for one training cycle, 15 minutes, 3 times each week for 16 weeks. Fifteen minutes of working memory practice, recalling the correct sequence of digits, each presented for 500 msec, from 5 digits up to 10 digits will be completed for 15 minutes following PATH training.
Group II: N-Back Working Memory TaskExperimental Treatment1 Intervention
Participants are required to compare each item on a computer screen to the item that they saw n-items back in the sequence. The participant plays a simple game where they control the movement of an astronaut that needs to collect correct gems, avoid incorrect gems, and also obstacles, to succeed at the game. If the participants performs well then they can be advanced to the 2-back, 3-back, 4-back, etc where they make similar matches but to earlier items in the sequence. This gamified task consists of a color n-back with 6 colors (a new color every 3 seconds, requiring subjects respond to targets by tapping the screen and navigating the astronaut to the targets, and avoiding the distractors) with 30% targets, and where the n-level will change every 2 minutes depending on performance (increase if performance is \>85% and decrease if \<75%). Sessions consist of 10 \~2 minute blocks, each with n-level as determined by the adaptive procedure and with user paced breaks between blocks.
Group III: Orientation Discrimination trainingPlacebo Group1 Intervention
The sham intervention will be Orientation Discrimination training that is identical to PATH training except instead of low contrast sinewave gratings moving left or right, 100% contrast stationary test and background sinewave gratings are used, both red, green, and black and white gratings, see patterns in Fig. 4 below. These patterns are randomly oriented left or right, at decreasing tilt angles as the test grating's orientation is identified correctly. These patterns only activate parvocells in ventral pathways (Ungerleider \& Mishkin, 1982; Kaplan \& Shapley, 1986) instead of activating dorsal pathways, the key component of PATH neurotraining. Therefore, this task does not speed up the brain's visual timing, which is a function of the dorsal stream. For the Orientation Discrimination task, the subject pushes the left arrow key when the test pattern is tilted left and the right arrow key when pattern is tilted right. Otherwise the two training tasks use the same paradigm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Perception Dynamics Institute
Lead Sponsor
Trials
2
Recruited
80+
University of South Alabama
Collaborator
Trials
44
Recruited
15,800+
University of California, San Diego
Collaborator
Trials
1,215
Recruited
1,593,000+
University of California, Riverside
Collaborator
Trials
33
Recruited
14,400+
Findings from Research
In a study involving 360 veterans with moderate to severe traumatic brain injury (TBI), both cognitive-didactic and functional-experiential rehabilitation approaches showed similar long-term outcomes in terms of overall functional independence and return to work or school after one year.
However, participants receiving cognitive-didactic treatment demonstrated significantly better short-term cognitive function immediately after treatment, particularly benefiting younger individuals in terms of returning to work or school, while older participants with more education fared better in independent living with the functional-experiential approach.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Rehabilitation of traumatic brain injury in active duty military personnel and veterans: Defense and Veterans Brain Injury Center randomized controlled trial of two rehabilitation approaches.Vanderploeg, RD., Schwab, K., Walker, WC., et al.[2009]
This clinical practice guideline (CPG) aims to fill the gap in physical therapy management for concussion, providing evidence-based recommendations for a broad range of patients who have experienced concussive events.
Previous guidelines have primarily focused on diagnosis and medical management, leaving a need for specific strategies in physical therapy to address the various impairments associated with concussion.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Physical Therapy Evaluation and Treatment After Concussion/Mild Traumatic Brain Injury.Quatman-Yates, CC., Hunter-Giordano, A., Shimamura, KK., et al.[2020]
A study involving 25 patients aged 12-20 with post-concussion syndrome showed that a multimodal physical therapy approach significantly reduced symptoms, as indicated by a decrease in the Post-Concussion Symptom Scale scores from an average of 18.2 to 9.1 after treatment.
The therapy also improved physical performance, with a 23% increase in maximum symptom-free heart rate during exercise and a 52% reduction in balance errors, demonstrating both safety and efficacy in managing post-concussion symptoms.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Multimodal impairment-based physical therapy for the treatment of patients with post-concussion syndrome: A retrospective analysis on safety and feasibility.Grabowski, P., Wilson, J., Walker, A., et al.[2022]
References
Cognitive versus functional approaches to rehabilitation after traumatic brain injury: commentary on a randomized controlled trial. [2019]
Rehabilitation of traumatic brain injury in active duty military personnel and veterans: Defense and Veterans Brain Injury Center randomized controlled trial of two rehabilitation approaches. [2009]
Physical Therapy Evaluation and Treatment After Concussion/Mild Traumatic Brain Injury. [2020]
Effects of Computerized Cognitive Training and Tai Chi on Cognitive Performance in Older Adults With Traumatic Brain Injury. [2021]
Multimodal impairment-based physical therapy for the treatment of patients with post-concussion syndrome: A retrospective analysis on safety and feasibility. [2022]
Electroencephalogram-based neurofeedback training in persons with stroke: A scoping review in occupational therapy. [2021]
Infra Low Frequency Neurofeedback Training for Trauma Recovery: A Case Report. [2022]
The Role of Controlled Exercise in Concussion Management. [2022]
Use of graded exercise testing in concussion and return-to-activity management. [2022]
Challenges in Determining the Role of Rest and Exercise in the Management of Mild Traumatic Brain Injury. [2015]