Neurotraining for Concussion

Not currently recruiting at 1 trial location

Overseen By Ming-Xiong Huang, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Perception Dynamics Institute

Disqualifiers: Epilepsy, Stroke, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to improve brain functions such as working memory and attention in individuals with mild traumatic brain injury (mTBI), commonly known as a concussion. Participants will engage in PATH neurotraining, which consists of computer-based exercises designed to enhance memory and processing speed. Researchers will test three different training schedules to determine the most effective routine. Individuals who have experienced one or more concussions and have ongoing memory issues might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatment options for 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 prior data suggests that this neurotraining is safe for mTBI patients?

Research shows that PATH neurotraining is generally well-tolerated. Studies have found that participants in PATH neurotraining have experienced improvements in cognitive skills, such as memory and focus, without major side effects. The treatment involves exercises to retrain brain pathways, akin to a mental workout routine.

Although studies do not specifically mention negative effects, the absence of such reports suggests the treatment is relatively safe. As this is an early-phase trial, the researchers are still collecting safety data, but initial results indicate that participants have not encountered major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PATH neurotraining for concussions because it offers a non-invasive, cognitive approach to recovery, unlike the typical rest and gradual return to activities. This technique uses adaptive computer-based exercises that adjust in difficulty to enhance visual and memory skills, potentially speeding up cognitive recovery. By combining tasks that challenge both visual contrast and memory recall, PATH neurotraining aims to improve brain function more effectively than current methods. Additionally, the flexibility in training frequency—ranging from once to three times a week—allows personalization to fit individual needs and schedules.

What evidence suggests that this trial's treatments could be effective for mTBI?

Research has shown that PATH neurotraining, one of the treatments studied in this trial, can improve mental skills like memory and focus, often affected after a concussion. One study found that participants using PATH improved their visual memory by 35%, outperforming other methods tested. PATH retrains the brain to process visual information more accurately and quickly. This enhancement in visual timing can boost other related mental skills. Overall, PATH neurotraining appears promising for helping individuals with mild brain injuries regain important mental abilities. Participants in this trial will receive PATH neurotraining combined with digit memory exercises at varying frequencies to assess its effectiveness. ^{2 3 4 6 7}

Who Is on the Research Team?

Teri Lawton, Ph.D.

Principal Investigator

Perception Dynamics Institute

Are You a Good Fit for This Trial?

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

Exclusion Criteria

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.

I have experienced memory loss for more than a day after an injury.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• N-Back Working Memory Training
• Orientation Discrimination
• PATH neurotraining

Trial Overview The 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.

How Is the Trial Designed?

Group I: PATH+DM neurotraining two times a week for 36 30-minute sessions Experimental Treatment 1 Intervention

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, 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.

Group II: PATH+DM neurotraining three times a week for 36 30-minute sessions Experimental Treatment 1 Intervention

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, 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.

Group III: PATH+DM neurotraining once a week for 36 30-minute sessions Experimental Treatment 1 Intervention

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, 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.

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+

Published Research Related to This Trial

A review of 14 studies indicates that EEG-based neurofeedback training significantly improves upper limb rehabilitation in stroke patients compared to traditional treatments, suggesting its effectiveness in occupational therapy.

Combining EEG neurofeedback with occupational therapy may enhance rehabilitation outcomes, particularly for outpatients, highlighting the need for customized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroencephalogram-based neurofeedback training in persons with stroke: A scoping review in occupational therapy. Yoo, IG.[2021]

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]

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]

The Buffalo Concussion Treadmill Test (BCTT) is a safe and reliable method for diagnosing physiological dysfunction in individuals with concussion and can differentiate it from other conditions like cervical injury.

The BCTT is also effective in quantifying the severity of concussion symptoms and is used to create a safe aerobic exercise program that can help speed up recovery and facilitate a return to normal activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of graded exercise testing in concussion and return-to-activity management. Leddy, JJ., Willer, B.[2022]

Current guidelines recommending complete rest after a sports concussion are being challenged, as research suggests that exercise may actually aid recovery for patients who take longer to heal.

A balanced approach is needed, where individuals recovering from a concussion should avoid triggers for severe symptoms while also gradually reintroducing exercise to promote better recovery and functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges in Determining the Role of Rest and Exercise in the Management of Mild Traumatic Brain Injury. Wells, EM., Goodkin, HP., Griesbach, GS.[2015]

The largest randomized controlled trial on rehabilitation after traumatic brain injury (TBI) shows that both cognitive and functional rehabilitation methods are effective, providing empirical support for their use in recovery.

Each type of intervention (cognitive and functional) has distinct advantages for specific subpopulations of TBI patients, highlighting the need for tailored rehabilitation approaches in occupational therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive versus functional approaches to rehabilitation after traumatic brain injury: commentary on a randomized controlled trial. Giles, GM.[2019]

Computerized cognitive training (CCT) significantly improved overall cognitive function, attention, and memory in older adults with traumatic brain injury compared to usual care over a 6-month period.

Tai chi (TC) also enhanced cognitive scores and showed lasting benefits, particularly in conceptualization and initiation/preservation, with effects observed up to 12 months, while also improving physical strength and mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Computerized Cognitive Training and Tai Chi on Cognitive Performance in Older Adults With Traumatic Brain Injury. Hwang, HF., Chen, CY., Wei, L., et al.[2021]

ILF Neurofeedback has been shown to effectively address the neuro-physiological effects of trauma, supported by various proof of concept studies, both large and small scale.

The paper advocates for the inclusion of ILF Neurofeedback and Alpha-Theta training in holistic treatment approaches for trauma survivors, highlighting its success in individual cases, such as that of an American combat veteran.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infra Low Frequency Neurofeedback Training for Trauma Recovery: A Case Report. Kirk, HW., Dahl, MG.[2022]

Recent research indicates that prolonged rest after a concussion may hinder recovery, suggesting that early, controlled activity could be beneficial instead.

The Buffalo Concussion Treadmill Test is a unique tool that helps assess exercise tolerance in individuals with postconcussion syndrome, allowing for personalized exercise programs that can improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Controlled Exercise in Concussion Management. Leddy, J., Hinds, A., Sirica, D., et al.[2022]

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]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10864051

Retraining Neural Pathways to Improve Cognitive Skills after a ... PATH is hypothesized to improve the precision in timing of visual events, and in turn improve cognitive functions that rely upon visual timing, such as working ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40217723/

Retraining Dorsal Visual Pathways Improves Cognitive Skills ... Results: On average, the PATH group exhibited a 35% improvement in VWM, compared to 15% for ReCollect and 5% for OD. A repeated-measures ANOVA ...

3. pathtoreading.com pathtoreading.com/wp-content/uploads/2022/03/Summary-Retraining-Neural-Pathways-Improves-Cognitive-Skills-After-A-Mild-Traumatic-Brain-Injury.pdf

Retraining Neural Pathways Improves Cognitive Skills After ... Research has found that the effects of a mTBI reflect disruptions of the neural networks for attention and working memory. After a mTBI, patients have ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03655782

Retraining Neural Pathways Improves Cognitive Skills After ... The proposed study tests the efficacy (Phase II) of 36 30-minute training sessions of PATH neurotraining followed by digit memory exercises to improve ...

5. pathtoreading.com pathtoreading.com/wp-content/uploads/2021/02/ValidationPATHneurotraining.pdf

PATH neurotraining Learning to See Quickly Improves Thinking Abilities: Why PATH neurotraining is essential for improving brain function and ease of learning.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11989825/

Retraining Dorsal Visual Pathways Improves Cognitive Skills ... Therefore, PATH neurotraining improved cognitive abilities not related to movement discrimination, and improved everyday cognitive performance ...

7. researchgate.net researchgate.net/publication/390298166_Retraining_Dorsal_Visual_Pathways_Improves_Cognitive_Skills_After_a_Mild_Traumatic_Brain_Injury

(PDF) Retraining Dorsal Visual Pathways Improves ... Results: On average, the PATH group exhibited a 35% improvement in VWM, compared to 15% for ReCollect and 5% for OD. A repeated-measures ANOVA found that ...