Not yet recruitingNAINTERVENTIONAL

Repetitive Transcranial Magnetic Stimulation Paired with Augmented Reality to Alter Concussion Symptoms

This research explores a new way to help people who experience persistent dizziness after a concussion. It combines a type of brain stimulation, called repetitive transcranial magnetic stimulation (rTMS), with exercises using special augmented reality glasses designed to improve balance. The main goal is to find out if this treatment can make a real difference in reducing dizziness symptoms. Researchers will compare results from people receiving the actual brain stimulation with those receiving a 'sham' (inactive) version to ensure any improvements are due to the treatment itself rather than just the expectation of feeling better. Participants will have brain stimulation followed by interactive balance training for 14 days over three weeks.

At a glance

Status

Not yet recruiting

Phase

Sponsor

McMaster University

Enrolment target

Start

01 Jan 2025

Estimated completion

01 Dec 2025

Mild Traumatic Brain Injury, Concussion Chronic Dizziness Vestibular Problem

What is this study about?

If you've had a concussion, it means you've had a mild head injury, often referred to as a mild traumatic brain injury (mTBI). While most people recover fully, some continue to experience symptoms like headaches, mood changes, or trouble thinking clearly. One common and very bothersome symptom is dizziness, which can really affect daily life, making it hard to drive, work, or simply get around. This dizziness can last for a long time after the initial injury.

This study is looking at a new approach to ease this persistent dizziness. It involves two main parts: a type of gentle brain stimulation called repetitive transcranial magnetic stimulation, or rTMS, and special balance training using augmented reality. Augmented reality uses glasses that let you see the real world with computer-generated images layered on top, making exercises more interactive and engaging. Researchers believe that by combining these two methods, they might be able to help the brain learn to manage dizziness better.

They want to find out if this combination treatment works better than no active treatment. To do this, some participants will receive the real rTMS, while others will receive a 'sham' rTMS, which feels similar but doesn't deliver the actual stimulation. This helps researchers understand if any improvements are genuinely from the treatment or simply because people expect to feel better. The study aims to see if this new method is not only effective but also practical for people with concussion-related dizziness.

Key takeaways

This study investigates a new treatment for ongoing dizziness after concussion.
It combines gentle brain stimulation (rTMS) with augmented reality balance exercises.
Researchers want to see if this treatment helps more than a sham (inactive) version.
The goal is to improve dizziness and balance for those affected.
Participants will have sessions over three weeks.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 65 years old. You must have had a mild head injury (concussion) that was diagnosed by a doctor, and you should still be experiencing dizziness for at least three months after the injury. Being able to understand English, either on your own or with an interpreter, is also important so you can follow the study instructions.

There are some reasons why you might not be able to join. For example, if you already had ongoing dizziness that wasn't related to a concussion, or if you have certain medical conditions like a pacemaker, metal implants (other than titanium), a history of seizures, or are pregnant. Also, if you're taking medications that increase the risk of seizures, or have certain untreated mental health conditions, you wouldn't be able to participate. If earlier scans showed a more severe head injury, you would also be excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Have you been diagnosed with a concussion?
Have you been dizzy for more than 3 months since your concussion?
Do you understand English (or have an interpreter)?
Do you have a pacemaker or metal implants (other than titanium)? (If yes, you may not be eligible)
Do you have a history of seizures or epilepsy? (If yes, you may not be eligible)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive gentle brain stimulation called rTMS to a specific part of your brain. Immediately after the stimulation, you will put on special augmented reality glasses and interact with digital objects as part of your balance training. This treatment will happen for 14 days over a period of three weeks. You'll need to attend appointments for these sessions. Researchers will also check your dizziness symptoms and balance at various times to see how you're responding to the treatment. The total duration of your involvement in the study will be explained in detail by the research team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a reduction in your dizziness symptoms and an improvement in your overall balance and quality of life. However, as with any medical study, there are potential risks, which could include mild side effects from the brain stimulation, such as headaches or discomfort at the stimulation site, though these are usually temporary. There is also no guarantee that the treatment will be effective for you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Greenbank Concussion Clinic
Verified postcode
Hamilton, Canada
McMaster University
Verified postcode
Hamilton, Canada

Common questions

What is rTMS?

rTMS stands for repetitive transcranial magnetic stimulation. It's a gentle, non-invasive method that uses magnetic pulses to stimulate specific areas of the brain.

What is augmented reality balance training?

It's a type of balance exercise where you wear special glasses that show computer-generated images on top of the real world, making your training more interactive and engaging.

What is a 'sham' treatment?

A 'sham' treatment looks and feels like the real treatment but doesn't contain the active ingredient or stimulation. It helps researchers understand if the real treatment truly works, or if people are just feeling better due to expectation.

Will I know if I'm getting the real treatment or the sham?

No, you won't know whether you are receiving the real brain stimulation or the sham. This is a common practice in research to ensure the results are fair and unbiased.

How long will the study take?

The treatment part of the study involves 14 sessions over three weeks. The overall duration of your participation, including assessments, will be explained by the study team.

How to find out more

Aimee J Nelson, PhD

nelsonaj@mcmaster.ca 9055259140 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.