500 Participants Needed

Electrical Vestibular Stimulation for Dizziness

(VST Trial)

Recruiting at 3 trial locations
RM
JD
Overseen ByJohn D Ralston, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Neursantys Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Electrical Vestibular Stimulation (EVS) for dizziness?

Research on a similar treatment, electrotactile vestibular substitution system (EVSS), showed that patients with vestibular loss experienced improved balance and reduced dizziness after using the system. Additionally, studies on electric stimulation in animals indicated faster recovery from balance issues, suggesting potential benefits for dizziness treatment.12345

Is electrical vestibular stimulation safe for humans?

Studies show that electrical vestibular stimulation (EVS) is generally safe for humans, with no reported side effects in a study involving stroke patients and a focus on long-term usage safety in another study.678910

How is the treatment Electrical Vestibular Stimulation (EVS) unique for treating dizziness?

Electrical Vestibular Stimulation (EVS) is unique because it uses electrical currents to directly stimulate the vestibular system, which is responsible for balance and spatial orientation. Unlike traditional treatments like medication or surgery, EVS aims to artificially restore vestibular function and has shown promise in improving balance and reducing dizziness by enhancing vestibular compensation.211121314

What is the purpose of this trial?

The aim of the study to is determine the safety, feasibility, efficacy, and persistence of non-invasive EVS to improve balance and gait performance in healthy individuals across the lifespan. Specifically, our objective is to measure balance and gait performance before, during and after exposure to single sessions and across repeated sequences of EVS at multiple study partner sites.

Research Team

RM

Ryan M Peters, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

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

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Electrical vestibular stimulation treatmentExperimental Treatment1 Intervention
Participants in this Arm will receive active treatment with swsEVS applied
Group II: Sham stimulation treatmentPlacebo Group1 Intervention
Participants in this Arm will receive sham treatment with no swsEVS applied.

Find a Clinic Near You

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+

Findings from Research

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.
Vestibular rehabilitation with electrotactile vestibular substitution: early effects.Uneri, A., Polat, S.[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.
Effect of electric stimulation on vestibular compensation in guinea pigs.Masumitsu, Y., Sekitani, T.[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.
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]

References

Vestibular rehabilitation with electrotactile vestibular substitution: early effects. [2021]
Effect of electric stimulation on vestibular compensation in guinea pigs. [2019]
Effectiveness of conventional versus virtual reality-based vestibular rehabilitation exercises in elderly patients with dizziness: a randomized controlled study with 6-month follow-up. [2022]
The effectiveness of exercise-based vestibular rehabilitation in adult patients with chronic dizziness: A systematic review. [2019]
The Effect of Supervision in Vestibular Rehabilitation in Patients with Acute or Chronic Unilateral Vestibular Dysfunction: A Systematic Review. [2023]
Electrical vestibular nerve stimulation (VeNS): a follow-up safety assessment of long-term usage. [2022]
Safety of repeated sessions of galvanic vestibular stimulation following stroke: a single-case study. [2019]
The efficacy of vestibular electrical stimulation on patients with unilateral vestibular pathologies. [2022]
Dizziness and the Acute Vestibular Syndrome at the Emergency Department: A Population-Based Descriptive Study. [2019]
Ocular torsion responses to sinusoidal electrical vestibular stimulation. [2021]
Electrical Vestibular Stimulation in Humans: A Narrative Review. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Gentamicin vestibulotoxicity impairs human electrically evoked vestibulo-ocular reflex. [2008]
Electrical stimulation of the peripheral and central vestibular system. [2023]
Electrical vestibular stimulation and space motion sickness. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security