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

NCT06846047 | Recruiting DMC FDA Device

• 1 other identifier: REB22-1006_MOD4
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 4

Brief Summary

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.

Conditions

Vestibulopathy

Keywords

age-related balance decline

Outcome Measures

Primary Outcomes (6)

• Postural Sway Measure of Balance Performance

  Postural sway will be calculated from acceleration profiles of the head measured using data from a head-mounted accelerometer in eyes open and eyes closed conditions. The raw acceleration signals are in units of G. The outcome measure is expressed as a sway power value (in Watts). Sway power measured during static standing has been shown to be a precise, quickly administered assessment of balance performance with excellent sensitivity in the identification of older adult fallers. We will complete the above 2-minute postural sway assessment (60 seconds eyes open followed by 60 seconds eyes closed) immediately before and after each of the 18 EVS treatment sessions in order to track each study participant's changes in balance performance following each treatment session and the cumulative change following completion of the 18 session treatment protocol.

  From enrollment through the end of treatment and up to 6 months post treatment

• Sensory Integration Measure of Balance Performance

  Sensory integration will be calculated from acceleration profiles of the head measured using data from a head-mounted accelerometer in eyes open and eyes closed conditions. The raw acceleration signals are in units of G. The outcome measure is calculated using a frequency spectrum analysis of the normalized contributions of the three sensory inputs (visual, vestibular, proprioceptive) to balance control. Sensory integration measured during static standing using wearable sensors or computerized dynamic posturography has been shown to be a precise, quickly administered assessment of sensory contributions to balance control with excellent sensitivity in the identification of sensory impairments that disrupt balance in older adults. Sensory reweighting will be calculated using the head acceleration data from the above 2-minute postural sway assessment (60 seconds eyes open followed by 60 seconds eyes closed) immediately before and after each of the 18 EVS treatment sessions in order to tr

  From enrollment through the end of treatment and up to 6 months post treatment

• Gait Velocity Measure of Gait Performance

  Dynamic gait performance will be measured using data from a head-mounted accelerometer. The raw acceleration signals are in units of G. For dynamic gait tasks, the outcome measures will be the peak walking speed (in Meters per Second) achieved over a set of pre-defined distances from 3 meters to 100 meters. Wearable sensor-based gait velocity tests are widely used in research for older adults with and without pathology, and have norm referenced values and robust clinimetric properties. The above gait velocity measurements will be carried out prior to the first EVS treatment session and following the final (18th) EVS treatment session in order to track the cumulative change in each study participant's gait performance following completion of the 18 session treatment protocol.

  From enrollment through the end of treatment and up to 6 months post treatment

• Gait Cadence Measure of Gait Performance

  Dynamic gait performance will be measured using data from a head-mounted accelerometer. The raw acceleration signals are in units of G. For dynamic gait tasks, the outcome measures will be gait cadence (in Steps per Second) over a set of pre-defined distances from 3 meters to 100 meters. Wearable sensor-based gait cadence tests are widely used in research for older adults with and without pathology, and have norm referenced values and robust clinimetric properties. The above gait cadence measurements will be carried out prior to the first EVS treatment session and following the final (18th) EVS treatment session in order to track the cumulative change in each study participant's gait performance following completion of the 18 session treatment protocol.

  From enrollment through the end of treatment and up to 6 months post treatment

• Step Length Measure of Gait Performance

  Dynamic gait performance will be measured using data from a head-mounted accelerometer. The raw acceleration signals are in units of G. For dynamic gait tasks, the outcome measures will be step length (in Meters) over a set of pre-defined distance from 3 meters to 100 meters. Wearable sensor-based step length tests are widely used in research for older adults with and without pathology, and have norm referenced values and robust clinimetric properties. The above step length measurements will be carried out prior to the first EVS treatment session and following the final (18th) EVS treatment session in order to track the cumulative change in each study participant's gait performance following completion of the 18 session treatment protocol.

  From enrollment through the end of treatment and up to 6 months post treatment

• Step Trajectory Measure of Gait Performance

  Dynamic gait performance will be measured using data from a head-mounted accelerometer. The raw acceleration signals are in units of G. For dynamic gait tasks, the outcome measures will be the distribution of head trajectories during each step (in Angular Degrees) over a set of pre-defined distances from 3 meters to 100 meters. Wearable sensor-based step trajectory tests are widely used in research for older adults with and without pathology, and have norm referenced values and robust clinimetric properties. The above step trajectory measurements will be carried out prior to the first EVS treatment session and following the final (18th) EVS treatment session in order to track the cumulative change in each study participant's gait performance following completion of the 18 session treatment protocol.

  From enrollment through the end of treatment and up to 6 months post treatment

Secondary Outcomes (2)

• Symbol Digit Matching Task (SDMT) Measure of Cognitive Performance

  From enrollment through the end of treatment and up to 6 months post treatment

• Montreal Cognitive Assessment (MoCA) of Cognitive Performance

  From enrollment through the end of treatment and up to 6 months post treatment

Other Outcomes (2)

• Migraine Disability Assessment (MIDAS) of Headaches

  From enrollment through the end of treatment and up to 6 months post treatment

• Dizziness Handicap Inventory (DHI) of Dizziness

  From enrollment through the end of treatment and up to 6 months post treatment

Study Arms (2)

Electrical vestibular stimulation treatment

EXPERIMENTAL

Participants in this Arm will receive active treatment with swsEVS applied

Device: electrical vestibular stimulation (EVS)

Sham stimulation treatment

SHAM COMPARATOR

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

Device: Sham Comparator

Interventions

electrical vestibular stimulation (EVS) DEVICE

EVS involves electrically activating the vestibular nerves by passing small electrical currents through electrodes placed on the mastoid processes (behind the ears) via battery powered, constant current isolated stimulators.

Electrical vestibular stimulation treatment

Sham Comparator DEVICE

No current is applied during EVS treatment

Sham stimulation treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to complete balance assessments such as standing with feet together/eyes open and feet together/eyes closed, both for at least 1 minute at a time, with no more than 1 minute rest required between tests.
• Able to complete gait assessment tests such as walking up to 200m on a flat surface without assistance.

You may not qualify if:

• Participants must not be using a pacemaker, cochlear implant, or any other implanted electronic device.
• Participants must be free from any diagnosed neurological or musculoskeletal injuries and/or disorders other than those explicitly being investigated (i.e., vertigo, multiple sclerosis, Parkinson's disease, concussion).
• Participants must have the mental capacity to provide consent and perform tasks required by the experiment.

Sponsors & Collaborators

• Neursantys Inc: lead
• Mitacs: collaborator
• University of Calgary: collaborator

Study Sites (4)

Caring Hands Caregivers

Cupertino, California, 95014, United States

RECRUITING

Neursantys

Menlo Park, California, 94025, United States

RECRUITING

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

Sparx Wellness Institute

Dieppe, New Brunswick, E1A 1P2, Canada

RECRUITING

Related Publications (15)

• Ralston JD, Raina A, Benson BW, Peters RM, Roper JM, Ralston AB. Physiological Vibration Acceleration (Phybrata) Sensor Assessment of Multi-System Physiological Impairments and Sensory Reweighting Following Concussion. Med Devices (Auckl). 2020 Dec 8;13:411-438. doi: 10.2147/MDER.S279521. eCollection 2020.

  PMID: 33324120 BACKGROUND

• 13. King J, Walters N, Clark S, Mehri N, Al Bastami J, Chan A, Ferrier E, Rodrigues N, Rempel J, Ralston JD, Peters RM. "Electrical Vestibular Stimulation for Therapeutic Balance Enhancement in Older Adults". Submitted for publication, 2024.

  BACKGROUND

• 12. Ralston JD, King JA, Rempel J, Peters RM, Chima B. "PHYBRATA Biomarker Assessments of Age-Related Balance Impairments and EVS Balance Restoration." 2023 Biomarkers of Aging Symposium, Buck Institute for Research on Aging, Novato, California, USA, Dec 4, 2023.

  BACKGROUND

• 11. King JA, Banman CJ, Walters N, Clark S, Ralston JD, Peters RM. "Electrical Vestibular Stimulation Therapeutics for Balance and Gait in Older Adults." Canadian Association on Gerontology 52nd Annual Scientific and Educational Meeting, CAG2023, Toronto, Ontario, Canada, October 26-28, 2023.

  BACKGROUND

• 10. Ralston JD, King J, Rempel J, Peters RM. "Wearable Bioelectronic Balance Restoration in Older Adults." AGE-WELL Annual Conf, Toronto, Ontario, Oct 24-26, 2023.

  BACKGROUND

• Dilda V, MacDougall HG, Curthoys IS, Moore ST. Effects of Galvanic vestibular stimulation on cognitive function. Exp Brain Res. 2012 Jan;216(2):275-85. doi: 10.1007/s00221-011-2929-z. Epub 2011 Nov 11.

  PMID: 22076407 BACKGROUND

• Lopez C, Cullen KE. Electrical stimulation of the peripheral and central vestibular system. Curr Opin Neurol. 2024 Feb 1;37(1):40-51. doi: 10.1097/WCO.0000000000001228. Epub 2023 Oct 25.

  PMID: 37889571 BACKGROUND

• Pires APBA, Silva TR, Torres MS, Diniz ML, Tavares MC, Goncalves DU. Galvanic vestibular stimulation and its applications: a systematic review. Braz J Otorhinolaryngol. 2022 Nov-Dec;88 Suppl 3(Suppl 3):S202-S211. doi: 10.1016/j.bjorl.2022.05.010. Epub 2022 Jul 5.

  PMID: 35915031 BACKGROUND

• Dlugaiczyk J, Gensberger KD, Straka H. Galvanic vestibular stimulation: from basic concepts to clinical applications. J Neurophysiol. 2019 Jun 1;121(6):2237-2255. doi: 10.1152/jn.00035.2019. Epub 2019 Apr 17.

  PMID: 30995162 BACKGROUND

• Deveze A, Bernard-Demanze L, Xavier F, Lavieille JP, Elziere M. Vestibular compensation and vestibular rehabilitation. Current concepts and new trends. Neurophysiol Clin. 2014 Jan;44(1):49-57. doi: 10.1016/j.neucli.2013.10.138. Epub 2013 Nov 6.

  PMID: 24502905 BACKGROUND

• Smith PF. Aging of the vestibular system and its relationship to dementia. Curr Opin Neurol. 2024 Feb 1;37(1):83-87. doi: 10.1097/WCO.0000000000001231. Epub 2023 Nov 30.

  PMID: 38038627 BACKGROUND

• 3. Agrawal Y, Smith PF, Merfeld DM, "6.36 - Dizziness, Imbalance and Age-Related Vestibular Loss, Editor(s): Bernd Fritzsch, The Senses: A Comprehensive Reference (Second Edition)." Elsevier,2020, p. 567-580, ISBN 9780128054093.

  BACKGROUND

• Iwasaki S, Yamasoba T. Dizziness and Imbalance in the Elderly: Age-related Decline in the Vestibular System. Aging Dis. 2014 Feb 9;6(1):38-47. doi: 10.14336/AD.2014.0128. eCollection 2015 Feb.

  PMID: 25657851 BACKGROUND

• Davis LE. Dizziness in elderly men. J Am Geriatr Soc. 1994 Nov;42(11):1184-8. doi: 10.1111/j.1532-5415.1994.tb06986.x.

  PMID: 7963205 BACKGROUND

• King JA, Walters N, Rodrigues N, Al Bastami J, Mehri N, Chan A, Spencer M, Clark S, Ferrier E, Orr SL, Rempel J, Hauenstein A, Roper JM, Ralston JD, Peters RM. Electrical vestibular stimulation to improve balance in older adults: a pilot randomized controlled trial. J Neuroeng Rehabil. 2025 Oct 31;22(1):231. doi: 10.1186/s12984-025-01749-y.

  PMID: 41174737 DERIVED

Study Officials

• Ryan M Peters, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan M Peters, PhD

CONTACT

403-606-5506; ryan.peters1@ucalgary.ca

John D Ralston, PhD

CONTACT

650-2158-418; john.ralston@neursantys.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 25, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Start date: March 1, 2027 End date: March 1, 2029
• Access Criteria: Study participants and other research groups studying age-related balance decline.

Locations

US (2); CA (2)