Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
Healthy Volunteers
ID06846047

Therapeutic Effects of Electrical Vestibular Stimulation (EVS) on Balance and Gait

Led by Neursantys Inc · Updated on 2025-02-25

500

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Neursantys Inc

Lead Sponsor

M

Mitacs

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the safety, feasibility, effectiveness, and lasting impact of non-invasive electrical vestibular stimulation (EVS) on balance and walking ability in healthy adults aged 18 to 100 years. It focuses on how EVS influences balance and gait by measuring performance before, during, and after single and repeated sessions at multiple partner sites. The study addresses age-related balance decline, known as presbystasis, which increases fall risk and affects independence, especially in older adults, and explores EVS as a potential non-invasive solution to restore vestibular function and possibly improve cognitive function and headaches. Participants will receive either active treatment with sub-threshold wideband stochastic EVS (swsEVS) or a sham treatment with no stimulation, in a randomized, single-blind design. The study involves 18 testing sessions over 5 to 6 weeks, where participants undergo EVS while alternating sitting and standing positions with eyes open or closed. Several assessments will be conducted including accelerometer-based gait and balance tests using a smartphone app, clinician-administered Functional Gait Assessments, static and dynamic balance tests, cognitive tests, and questionnaires about headaches and dizziness. Participants will complete balance and gait tests before and after each EVS session, with follow-up visits at 3 weeks, 6 weeks, 3 months, and 6 months post-treatment to evaluate lasting effects. Cognitive assessments and headache questionnaires are done during the first and last treatment sessions. Safety and tolerability are monitored throughout. The main outcomes measured include various balance and gait parameters such as postural sway, gait velocity, cadence, step length, and step trajectory, along with cognitive performance tests, to assess the impact of the stimulation over time.

CONDITIONS

Brief Title

Therapeutic Effects of Electrical Vestibular Stimulation (EVS) on Balance and Gait

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to complete balance tests such as standing with feet together and eyes open or closed for at least 1 minute each, with no more than 1 minute rest between tests
  • Able to walk up to 200 meters on a flat surface without assistance
  • Adults aged 18 to 100 years
  • Healthy individuals without neurological or musculoskeletal disorders other than those studied
Not Eligible

You will not qualify if you...

  • Use of pacemaker, cochlear implant, or any implanted electronic device
  • Diagnosed neurological or musculoskeletal injuries or disorders such as vertigo, multiple sclerosis, Parkinson's disease, or concussion
  • Inability to provide informed consent or perform required tasks in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 5 to 6 weeks

Participants receive 18 sessions of electrical vestibular stimulation (swsEVS) or sham stimulation over a 5-6 week period to improve balance and gait performance. Each session includes gait and balance tests before and after a single 20-minute stimulation session.

18 visits (in-person) with gait and balance testing before and after each session

Follow-up

Duration - 6 months

Participants return for follow-up visits at 3 weeks, 6 weeks, 3 months, and 6 months after treatment to repeat gait and balance tests and assess the persistence of any improvements.

4 visits (in-person) at 3 weeks, 6 weeks, 3 months, and 6 months post-treatment

Trial Site Locations

Total: 4 locations

1

Caring Hands Caregivers

Cupertino, California, United States, 95014

Actively Recruiting

2

Neursantys

Menlo Park, California, United States, 94025

Actively Recruiting

3

University of Calgary

Calgary, Alberta, Canada, T2N 1N4

Actively Recruiting

4

Sparx Wellness Institute

Dieppe, New Brunswick, Canada, E1A 1P2

Actively Recruiting

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Research Team

R

Ryan M Peters, PhD

J

John D Ralston, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Physiological Vibration Acceleration (Phybrata) Sensor Assessment of Multi-System Physiological Impairments and Sensory Reweighting Following Concussion.

John D Ralston, Ashutosh Raina, Brian W Benson...

https://pubmed.ncbi.nlm.nih.gov/33324120