Brain Stimulation and Augmented Reality for Concussion

Not yet recruiting at 1 trial location

Overseen By Daniel B Soppitt, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: Seizure medications

Disqualifiers: Chronic dizziness, Seizure, Epilepsy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining brain stimulation and balance exercises can reduce dizziness in people who have had a concussion. Specifically, it tests repetitive transcranial magnetic stimulation (rTMS), which uses magnetic pulses to target brain areas controlling movement. Participants will wear augmented reality glasses to interact with digital objects during balance tasks over 14 days. Ideal candidates are those who have experienced a mild traumatic brain injury (mTBI) and have been dizzy for more than three months after the injury. As an unphased trial, this study offers a unique opportunity to explore innovative treatments for post-concussion dizziness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you must be able to continue your current medical therapies during the study.

What prior data suggests that this brain stimulation and balance training protocol is safe for individuals with concussion-related dizziness?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for both healthy individuals and those with brain conditions. Studies have found that when used following safety guidelines, rTMS is well-tolerated, and serious side effects are rare.

Other research has used rTMS to help manage symptoms after a concussion, such as reducing chronic headaches. As a noninvasive procedure, it doesn't involve surgery or entering the body, making it less risky than other brain stimulation methods.

Overall, rTMS is considered a safe option for treating brain-related issues. Many studies have tested it with positive results regarding safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of using Repetitive Transcranial Magnetic Stimulation (rTMS) for concussion treatment because it offers a non-invasive approach that directly targets brain areas involved in recovery. Unlike traditional treatments for concussions, which often involve rest and symptom management, rTMS uses magnetic fields to stimulate nerve cells in the brain and promote healing. This technique has the potential to accelerate recovery time and improve cognitive function without the need for medication. Additionally, the use of augmented reality in conjunction with rTMS could enhance visual and spatial processing, offering a comprehensive approach to concussion rehabilitation.

What evidence suggests that this trial's treatments could be effective for dizziness due to concussion?

Research has shown that repetitive transcranial magnetic stimulation (rTMS), which participants in this trial may receive, can help with concussion symptoms. One study found that people who received rTMS had better cognitive function than those who did not. Another study found that rTMS sessions reduced headaches and improved focus and daily activities. A small study also suggested that rTMS is a promising and manageable option for those with recent concussions. While some studies have mixed results, overall, rTMS appears to be a potential treatment for dizziness and other symptoms following a concussion. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with persistent dizziness due to a concussion, vertigo, or other vestibular disorders. Participants should be able to undergo brain stimulation and balance training. Details on specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

Comprehension of spoken and written English language or have a language interpreter present for all study visits

I have been feeling dizzy for more than 3 months after a head injury.

Diagnosis of mTBI according to the American Congress of Rehabilitation Medicine Diagnostic Criteria (Silverberg et al., 2023) confirmed by Dr. Rathbone

Exclusion Criteria

I have a long-term history of feeling dizzy not caused by head injuries.

Individuals with a positive CT head at the time of injury

I do not have a pacemaker, metal implants (except titanium), untreated mental disorders, am not pregnant, and have no history of seizures or epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repetitive transcranial magnetic stimulation (rTMS) paired with balance training using augmented reality for 14 days over 3 weeks

3 weeks

14 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Augmented reality vestibular rehabilitation therapy
• Repetitive Transcranial Magnetic Stimulation

Trial Overview The study tests if repetitive transcranial magnetic stimulation (rTMS) paired with augmented reality balance training can alleviate dizziness symptoms from concussions. It compares real rTMS effects against sham (placebo) rTMS over a period of 14 days in three weeks.

How Is the Trial Designed?

Group I: Real rTMS Active Control 2 Interventions

Group II: Sham rTMS Placebo Group 2 Interventions

Repetitive Transcranial Magnetic Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Migraines

Approved in European Union as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder
• Anxiety disorders

Approved in Canada as rTMS for:

• Major depressive disorder
• Obsessive-compulsive disorder

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Greenbank Concussion Clinic

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

In a safety and efficacy study involving a 26-year-old man with severe traumatic brain injury (TBI), a 6-week rTMS protocol showed no adverse events, indicating it is a safe treatment option for individuals in a minimally conscious state.

The rTMS treatment was associated with a trend toward significant neurobehavioral improvements and enhanced neural conduction, suggesting its potential to facilitate recovery in patients with severe TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation-associated neurobehavioral gains during coma recovery. Louise-Bender Pape, T., Rosenow, J., Lewis, G., et al.[2016]

Repetitive transcranial magnetic stimulation (rTMS) can be safely administered to individuals with traumatic brain injury (TBI) when following specific guidelines, minimizing risks such as seizures.

In a case study of a 48-year-old man with severe TBI, rTMS treatment for post-TBI depression over 6 weeks led to a 49% reduction in depression symptoms, demonstrating its potential efficacy in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary guidelines for safe and effective use of repetitive transcranial magnetic stimulation in moderate to severe traumatic brain injury. Nielson, DM., McKnight, CA., Patel, RN., et al.[2022]

Transcranial magnetic stimulation (TMS) is a painless technique that can stimulate the brain and potentially improve brain function by altering neuronal excitability and promoting brain plasticity.

Repetitive TMS (rTMS) has shown positive therapeutic effects in individuals with motor disorders and psychiatric conditions, indicating its potential as a promising treatment for traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation: a possible treatment for TBI. Pape, TL., Rosenow, J., Lewis, G.[2019]

Repetitive transcranial magnetic stimulation (rTMS) was found to be safe for a patient with an implanted subdural cortical electrode, showing no serious adverse effects during treatment.

Ex-vivo experiments indicated that rTMS caused only a slight increase in coil temperature and no displacement of the electrodes, suggesting that rTMS can be safely applied in clinical settings for patients with such implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. Phielipp, NM., Saha, U., Sankar, T., et al.[2019]

Repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (DLPFC) showed a significant short-term antidepressant effect in patients with depression following traumatic brain injury (TBI), with a standardized mean difference (SMD) of 1.03 based on seven randomized controlled trials.

While rTMS improved visuospatial memory in post-TBI patients, its effects on cognitive functions like processing speed and selective attention were not significant, and it did not show superiority over sham treatment for postconcussion syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of repetitive transcranial magnetic stimulation on depression and cognition in individuals with traumatic brain injury: a systematic review and meta-analysis. Tsai, PY., Chen, YC., Wang, JY., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

In a study involving 100 adult migraine patients, high-rate repetitive transcranial magnetic stimulation (rTMS) significantly reduced headache frequency by 78.7% and severity by 76.6% compared to sham stimulation after one month.

The treatment was found to be safe, with only one patient experiencing transient drowsiness, indicating that rTMS is a promising option for migraine prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-rate repetitive transcranial magnetic stimulation in migraine prophylaxis: a randomized, placebo-controlled study. Misra, UK., Kalita, J., Bhoi, SK.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12134812/

Use of repetitive transcranial magnetic stimulation in traumatic ... A statistically significant improvement in cognitive function was observed after TMS compared to control group with SMD of 0.7 (95% CI: 0.25, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715925010335

Long-term Efficacy of Repetitive Transcranial Magnetic ... In short, ten sessions of rTMS at the left MC can effectively reduce headache symptoms and interferences of concentration and daily activities.

3. nature.com nature.com/articles/s41598-019-41923-6

A Pilot Randomised Double-Blind Study of the Tolerability ... The results support rTMS as a tolerable and potentially effective treatment option for individuals with a recent (<1 year) concussion. Similar ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06112093?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(manage%20syndrome%20OR%20%22mirage%22%20OR%20%22%20myelodysplasia-infection-restriction%20of%20growth-adrenal%20hypoplasia-genital%20anomalies-enteropathy%20syndrome%22%20OR%20%22%20myelodysplasia-infection-restriction%20of%20growth-adrenal%20hypoplasia-genital%20phenotypes-enteropathy%20syndrome%22%20OR%20%22%20myelodysplasia,%20infection,%20restriction%20of%20Growth,%20adrenal%20Hypoplasia,%20genital%20phenotypes,%20and%20enteropathy%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING))&rank=4

Repetitive Transcranial Magnetic Stimulation for Post- ... This study uses rTMS to manage chronic headaches to improve post-concussion symptoms and reduce the economic burden due to delayed recovery. This project aims ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000007748

Repetitive TMS does not improve cognition in patients with ... This study provides Class II evidence that for individuals with chronic DAI, high-frequency rTMS over the left DLPFC does not significantly improve cognition.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9879417/

Safety Review for Clinical Application of Repetitive ... rTMS conforming to the current safety guidelines (Tables 3, 4, 5) can be applied safely to both healthy volunteers and patients with acquired brain diseases ...

7. journals.lww.com journals.lww.com/headtraumarehab/fulltext/2020/11000/safety_considerations_for_the_use_of_transcranial.6.aspx

Safety Considerations for the Use of Transcranial Magnetic... We report cumulative findings from safety examinations, including serious adverse events (AEs) of a repetitive transcranial magnetic stimulation (rTMS) ...

8. mayoclinic.org mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625

Transcranial magnetic stimulation Repetitive TMS is a noninvasive form of brain stimulation. Unlike vagus nerve stimulation or deep brain stimulation, rTMS does not require ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X19304966

Safety and tolerability of transcranial magnetic and direct ... Standard non-invasive brain stimulation paradigms are safe and well-tolerated in children and should be considered minimal risk.