Electrical Vestibular Stimulation for Dizziness

(VST Trial)

Recruiting at 3 trial locations

Overseen By John D Ralston, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neursantys Inc

Disqualifiers: Pacemaker, Cochlear implant, Neurological disorders, others

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

Compensation: Varies

Number of Visits: 22

Duration: 5-6 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method called Electrical Vestibular Stimulation (EVS) to improve balance and walking. Researchers aim to determine if this technique is safe, easy to use, and effective in enhancing movement. Participants will be divided into groups, with some receiving the actual treatment and others a placebo, to compare results. The trial seeks individuals who can stand still and walk on flat surfaces without assistance. It is not suitable for those with electronic implants or certain health conditions, such as vertigo or Parkinson's disease. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Electrical Vestibular Stimulation is safe for improving balance and gait performance?

Research shows that Electrical Vestibular Stimulation (EVS) is generally safe for people. Studies have found that this treatment is well-tolerated, with no major safety issues reported. One study discovered that EVS can help improve balance in older adults without causing significant side effects. Another study noted that a portable EVS device meets strict safety standards. These findings suggest that EVS could safely improve balance and walking, with minimal risk of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Electrical Vestibular Stimulation (EVS) for treating dizziness because it offers a novel approach by directly influencing the vestibular system, which is responsible for balance and spatial orientation. Unlike standard treatments, such as vestibular rehabilitation therapy or medication that often target symptoms indirectly, EVS uses gentle electrical impulses to stimulate the vestibular nerves, potentially providing quicker and more direct relief. This method can be non-invasive and convenient, making it a promising alternative for patients who haven’t found success with conventional therapies.

What evidence suggests that Electrical Vestibular Stimulation is effective for improving balance and gait performance?

Research has shown that Electrical Vestibular Stimulation (EVS), which participants in this trial may receive, can help reduce dizziness and improve balance. One study found that EVS lessened vertigo symptoms in people with inner ear balance issues. Another study demonstrated that EVS helped older adults improve their balance, addressing age-related problems. These findings suggest that EVS might be a useful treatment for improving stability and reducing dizziness. While the results are promising, more research is needed to confirm its effectiveness for different groups. ^{1 4 6 7 8}

Who Is on the Research Team?

Ryan M Peters, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for healthy individuals who experience dizziness and are interested in testing a non-invasive treatment to improve balance and gait. Specific eligibility criteria details were not provided, so general health status may be considered.

Inclusion Criteria

I can walk up to 200m by myself.

I can stand with my feet together and eyes open or closed for at least 1 minute.

Exclusion Criteria

I can understand and agree to the study's requirements.

I don't have any neurological or musculoskeletal issues except for the condition being studied.

Participants must not be using a pacemaker, cochlear implant, or any other implanted electronic device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 18 sessions of electrical vestibular stimulation (EVS) over a 5-6 week period to improve balance and gait performance.

5-6 weeks

18 visits (in-person)

Follow-up

Participants are monitored for persistence of performance improvements with follow-up sessions at 3 weeks, 6 weeks, 3 months, and 6 months post-treatment.

6 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Electrical Vestibular Stimulation (EVS)

Trial Overview

The study tests the effects of Electrical Vestibular Stimulation (EVS) on balance and gait compared to a sham (fake) treatment. Participants will have their performance measured before, during, and after EVS sessions at various locations.

How Is the Trial Designed?

Group I: Electrical vestibular stimulation treatment Experimental Treatment 1 Intervention

Participants in this Arm will receive active treatment with swsEVS applied

Group II: Sham stimulation treatment Placebo Group 1 Intervention

Participants in this Arm will receive sham treatment with no swsEVS applied.

Who Is Running the Clinical Trial?

Neursantys Inc

Lead Sponsor

Trials

1

Recruited

500+

Mitacs

Industry Sponsor

Trials

46

Recruited

5,200+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Published Research Related to This Trial

Electrical vestibular stimulation (EVS) is being explored as a treatment for bilateral vestibulopathy, with three promising approaches: vestibular co-stimulation with cochlear implants, vestibular implants, and galvanic vestibular stimulation.

While all three methods have shown effectiveness in stimulating vestibular function, there is currently no consensus on which approach is best suited for specific patient types, indicating a need for further research to determine their applicability and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Vestibular Stimulation in Humans: A Narrative Review. Sluydts, M., Curthoys, I., Vanspauwen, R., et al.[2020]

Dizziness accounts for 2.1% of all emergency department visits, with a notable incidence of 477 cases per 100,000 inhabitants, highlighting its commonality in acute care settings.

Patients presenting with acute vestibular syndrome (AVS) have a significantly higher risk of cerebrovascular causes of dizziness (10.0%) compared to those without AVS (3.6%), indicating the importance of neurological assessment in dizzy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dizziness and the Acute Vestibular Syndrome at the Emergency Department: A Population-Based Descriptive Study. Ljunggren, M., Persson, J., Salzer, J.[2019]

The study introduces a non-invasive method for tracking eye movements in response to electrical vestibular stimulation (EVS) using sinusoidal stimuli and an infrared camera, making it more practical than traditional invasive techniques.

Results showed that ocular torsion responses matched the frequency of the EVS stimulus, indicating that the brain interprets these signals as head roll velocity, which could help in diagnosing vestibular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular torsion responses to sinusoidal electrical vestibular stimulation. Mackenzie, SW., Reynolds, RF.[2021]

Electric stimulation significantly improved vestibular compensation in guinea pigs after labyrinthectomy, with the 0.6 mA square wave and pulse wave groups showing the fastest recovery in nystagmus and head deviations.

The study involved pharmacological labyrinthectomy and assessed compensation over 24 hours, indicating that electric stimulation can be a beneficial intervention for enhancing recovery in vestibular function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of electric stimulation on vestibular compensation in guinea pigs. Masumitsu, Y., Sekitani, T.[2019]

A systematic review of four randomized controlled trials indicates that exercise-based vestibular rehabilitation (VR) is effective in improving symptoms of chronic dizziness in adults, as measured by the Vertigo Symptom Scale.

The study found that VR not only helps reduce dizziness but also improves balance, fall risk, and emotional well-being, highlighting its potential as a beneficial therapy for patients experiencing chronic dizziness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise-based vestibular rehabilitation in adult patients with chronic dizziness: A systematic review. Kundakci, B., Sultana, A., Taylor, AJ., et al.[2019]

Electrical vestibular stimulation (EVS) significantly worsened dynamic balance in subjects, indicating its potential as a provocative test for space motion sickness (SMS).

Out of 30 subjects, 17 experienced symptoms of SMS during EVS, suggesting a direct relationship between the discomfort felt and the disturbances in balance, which could help in developing ground-based tests for SMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical vestibular stimulation and space motion sickness. Severac, A.[2019]

A study involving 32 elderly patients with dizziness showed that vestibular rehabilitation exercises supported by virtual reality led to significant improvements in dizziness symptoms and functional mobility compared to conventional rehabilitation methods.

After 6 months, those who underwent virtual reality rehabilitation experienced lasting benefits in emotional well-being, balance, and anxiety levels, indicating that this innovative approach may enhance recovery in older adults with chronic dizziness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of conventional versus virtual reality-based vestibular rehabilitation exercises in elderly patients with dizziness: a randomized controlled study with 6-month follow-up. Kanyılmaz, T., Topuz, O., Ardıç, FN., et al.[2022]

In patients with gentamicin vestibulotoxicity (GV), the electrically evoked vestibulo-ocular reflex (eVOR) is significantly impaired, particularly the phasic component, which is reduced to one-fifth of normal amplitude and has prolonged latency.

The study indicates that vestibular hair cells are crucial for mediating eVOR, as the impairment observed in GV patients suggests that damage to these cells affects the reflex, making eVOR abnormalities a potential marker for vestibular injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gentamicin vestibulotoxicity impairs human electrically evoked vestibulo-ocular reflex. Aw, ST., Todd, MJ., Aw, GE., et al.[2008]

Galvanic vestibular stimulation (GVS) has shown promise in improving balance and perceptual responses in patients with vestibular disorders and Parkinson's disease, indicating its potential as a therapeutic intervention.

Intracranial electrical brain stimulation (iEBS) has provided important insights into how the brain processes vestibular information, revealing key areas involved in this network and suggesting that GVS can promote beneficial neural changes in patients with vestibular loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the peripheral and central vestibular system. Lopez, C., Cullen, KE.[2023]

A study involving 10 patients with bilateral vestibular loss due to aminoglycoside-induced ototoxicity showed that vestibular rehabilitation using an electrotactile vestibular substitution system (EVSS) significantly improved balance and dizziness symptoms after just 10 training sessions.

All participants demonstrated enhanced scores in both the Sensory Organization Test (SOT) and the Dizziness Handicap Inventory (DHI) following the training, indicating the effectiveness of EVSS as a new treatment approach for vestibular rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation with electrotactile vestibular substitution: early effects. Uneri, A., Polat, S.[2021]

In a study of 25 long-term users of electrical vestibular nerve stimulation (VeNS) over an average of 22 months, no adverse events or significant side effects were reported, indicating a strong safety profile for this treatment.

Formal audiometry tests showed no significant changes in hearing function among 18 users, suggesting that long-term VeNS does not negatively impact hearing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical vestibular nerve stimulation (VeNS): a follow-up safety assessment of long-term usage. McCulloch, E., Kumar Goothy, SS., McKeown, J.[2022]

Galvanic vestibular stimulation (GVS) applied for 30 minutes over 5 consecutive days was well-tolerated by a stroke patient, with no reported side effects during or after the sessions.

The study suggests that increasing the duration and frequency of GVS could lead to further improvements in stroke impairment, providing a foundation for larger studies on its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repeated sessions of galvanic vestibular stimulation following stroke: a single-case study. Wilkinson, D., Zubko, O., Sakel, M.[2019]

Supervised vestibular rehabilitation treatment programs generally show better outcomes in improving emotional status, dizziness, and balance in individuals with unilateral vestibular disorders, based on a systematic review of six randomized control trials.

However, the review did not find strong evidence that supervised programs are significantly superior to unsupervised or home-based training, highlighting limitations in the self-reported measures used in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Supervision in Vestibular Rehabilitation in Patients with Acute or Chronic Unilateral Vestibular Dysfunction: A Systematic Review. Lilios, A., Chimona, T., Nikitas, C., et al.[2023]

Vestibular electrical stimulation (VES) combined with medical treatment showed improvements in dizziness severity and daily life activities in patients with benign paroxysmal positional vertigo (BPPV), but did not significantly outperform medical treatment alone.

The study involved 19 patients over a treatment period of 12 sessions, indicating that while VES may enhance treatment outcomes, further research with larger sample sizes is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of vestibular electrical stimulation on patients with unilateral vestibular pathologies. Karan, A., Alptekin, HK., Çapan, N., et al.[2022]

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