Brain Stimulation and Augmented Reality for Concussion

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McMaster University

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

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.

Research Team

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.

Treatment Details

Interventions

• Augmented reality vestibular rehabilitation therapy (Behavioral Intervention)
• Repetitive Transcranial Magnetic Stimulation (Device)

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 Canada for the following indications:

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+

Evan Stein

McMaster University

Chief Medical Officer since 2015

MD, PhD

Sam

McMaster University

Chief Executive Officer since 2023

MBA from McMaster University

Greenbank Concussion Clinic

Collaborator

Trials

1

Recruited

40+