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

ConditionsMild Traumatic Brain Injury, Concussion Chronic Dizziness Vestibular Problem

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorMcMaster University

About 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 does not accept healthy volunteers

Qualifiers

Male or female aged 18-65 years

Diagnosis of mTBI according to the American Congress of Rehabilitation Medicine Diagnostic Criteria (Silverberg et al., 2023). All participants have diagnosis confirmed with Dr. Rathbone before enrollment.

Persistent dizziness beyond 3-months following the initial head injury.

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

Disqualifiers

History of chronic dizziness unrelated to concussive events.

Contraindications to TMS: presence of pacemaker, metal/electrical/magnetic implants not including titanium, known history of untreated or uncontrolled psychological disorders, pregnancy, history of seizure or diagnoses of epilepsy, taking medications that increase the risk of seizure.

Inability to continue current medical therapies for the duration of the study.

If imaging was done at the time of injury, individuals with a positive CT head will be excluded from the study

Trial design

Design model

Parallel

Treatments tested in this trial

Repetitive transcranial magnetic stimulation
Device
Repetitive transcranial magnetic stimulation (intermittent theta burst stimulation) will be delivered using a Magstim Rapid 2 stimulator (Magstim, Whitland, UK) guided using neuronavigation (Brainsight, Rogue Research, Montreal, QC, Canada) to target primary motor cortex. Participants will receive 14 days of stimulation over a 3-week period. Stimulation will use a protocol called accelerated iTBS (Duprat et al., 2016) whereby iTBS will be delivered three times during the same study session. Each iTBS session will deliver 600 pulses in 50 Hz bursts of 3 pulses for a total of 1800 pulses delivered each day. iTBS sessions will each be separated by 15 minutes (Duprat et al., 2016; Wu et al., 2013). Stimulation will be delivered at 70% of the participant's resting motor threshold. Immediately following each 600-pulse period of iTBS, individuals will participate in 5 to 10 minutes of AR vestibular rehabilitation therapy.
Augmented reality vestibular rehabilitation therapy
Behavioral
Participants will complete the vestibular training through Nreal Air AR Glasses (Nreal, China). The vestibular training task was custom-made in Unity V2021.3.14fI software using C+ script language. Participants will be standing upright for the AR training, with a safety bar positioned directly in front of them should they need to hold onto something. A large cross-shaped target will be positioned approximately 3 feet in front of the participant's head with its vertical center aligned with the participant's midline. This will act as a visual starting point. The training is adapted from clinical vestibular rehabilitation training methods used in PCD. The vestibular training task consists of locating and tracking a series of moving 3-dimensional balls presented at random within the participant's field of view.
SHAM repetitive transcranial magnetic stimulation
Device
Sham repetitive transcranial magnetic stimulation will be delivered using a Magstim Rapid 2 sham stimulator (Magstim, Whitland, UK) guided using neuronavigation (Brainsight, Rogue Research, Montreal, QC, Canada) to target primary motor cortex. Participants will receive 14 days of sham stimulation over a 3-week period. Stimulation will use a protocol called accelerated iTBS (Duprat et al., 2016) whereby sham iTBS will be delivered three times during the same study session. Each sham iTBS session will sound and feel identical to real iTBS delivery, but will not deliver a stimulating current. Sham iTBS sessions will each be separated by 15 minutes (Duprat et al., 2016; Wu et al., 2013). Sham stimulation will be delivered at 70% of the participant's resting motor threshold. Immediately following each 600-pulse period of sham iTBS, individuals will participate in 5 to 10 minutes of AR vestibular rehabilitation therapy.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Sham rTMSSham comparator 2 interventions

Group B: Real rTMSActive comparator 2 interventions

Trial outcomes

Primary outcomes

Dizziness Handicap Inventory (DHI)

The DHI is a well-validated 25-item questionnaire which will be used to assess functional, physical, and emotional domains of disability due to dizziness. The test has a total possible score of 100 points, whereby 16-34 = mild handicap, 36-52 = moderate handicap, and 54+ = severe handicap.

Time frame