Brain Stimulation and Augmented Reality for Concussion

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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Augmented reality vestibular rehabilitation therapy and Repetitive Transcranial Magnetic Stimulation for concussion?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can reduce headache severity and depression in people with post-concussion symptoms. It has also shown positive outcomes in treating depression and cognitive issues in individuals with traumatic brain injury, suggesting it may help with concussion recovery. ^{1 2 3 4 5}

Is brain stimulation using rTMS generally safe for humans?

Repetitive transcranial magnetic stimulation (rTMS) has been studied for safety in various conditions, including traumatic brain injury and migraines. It is generally considered safe when guidelines are followed, with only minor side effects like transient drowsiness reported in some cases. ^{4 6 7 8 9}

How is the treatment of concussions with repetitive transcranial magnetic stimulation (rTMS) different from other treatments?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate specific areas of the brain, unlike traditional drug therapies. It has shown potential in reducing headache severity and improving mood and quality of life in patients with persistent post-concussion symptoms, which are not typically addressed by standard treatments. ^{1 5 10 11 12}

What is the purpose of this trial?

This study aims to determine whether the delivery of brain stimulation paired with a balance training task can improve symptoms of dizziness for individuals experiencing these symptoms due to concussion. The main questions it aims to answer are: * Does repetitive transcranial magnetic stimulation (rTMS) paired with balance training improve the symptoms of dizziness in individuals with persistent dizziness due to concussion? * Is the proposed rTMS and balance training protocol feasible in this population? Researchers will compare results from a sham rTMS group with those from a real rTMS group to see if any observed changes are from the placebo effect rather than the expected effects of real rTMS. Participants will receive pulses of rTMS to the area of the brain responsible for control of movement and then be asked to interact with digital objects using augmented reality glasses for 14 days over 3 weeks.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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) 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of Persistent Post-Traumatic Headache and Post-Concussion Symptoms Using Repetitive Transcranial Magnetic Stimulation: A Pilot, Double-Blind, Randomized Controlled Trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation: a possible treatment for TBI. [2019]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation-associated neurobehavioral gains during coma recovery. [2016]

5. Australia pubmed.ncbi.nlm.nih.gov

Using transcranial magnetic stimulation to quantify electrophysiological changes following concussive brain injury: a systematic review. [2022]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

7. Netherlands 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. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

High-rate repetitive transcranial magnetic stimulation in migraine prophylaxis: a randomized, placebo-controlled study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Preliminary guidelines for safe and effective use of repetitive transcranial magnetic stimulation in moderate to severe traumatic brain injury. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Evidence of alterations in transcallosal motor inhibition as a possible long-term consequence of concussions in sports: A transcranial magnetic stimulation study. [2018]

11. Israel pubmed.ncbi.nlm.nih.gov

[Exhaustion of motor cortex after head injury--revealed by transcranial magnetic stimulation]. [2006]

12. England pubmed.ncbi.nlm.nih.gov

Probing the effects of mild traumatic brain injury with transcranial magnetic stimulation of the primary motor cortex. [2015]