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NOT YET RECRUITING
NCT07890623
NA

EVS With Exercise for Balance With Older Adults

Sponsor: University of Calgary

View on ClinicalTrials.gov

Summary

This study will test whether electrical stimulation of the balance system adds benefit to an exercise program for adults aged 60 years and older. The treatment is called noisy electrical vestibular stimulation (nEVS). It uses low-level electrical current delivered through electrodes placed behind the ears and on the neck. Participants who join the trial will be assigned by chance, in equal numbers, to active nEVS or sham nEVS. Sham sessions use the same equipment and preparation and will have no current delivered. Both groups will attend the RISE STRONG exercise program for 12 weeks. Exercise classes take place twice weekly and last about 35 to 45 minutes. Participants will attend 18 active or sham sessions over six weeks. Each session lasts 20 minutes. Two sessions each week may take place on exercise days, and one additional weekly visit is expected. The stimulation course may take place during exercise weeks 1 to 6 or 7 to 12. Standing balance will be measured before and after the six-week course to compare the two groups. Other assessments examine walking, physical function, cognition, and self-reported health. The study will also record attendance, treatment completion, and adverse events.

Official title: Electrical Vestibular Stimulation for Balance With Exercise in Older Adults

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2027-01-01

Completion Date

2028-11-30

Last Updated

2026-11-02

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Noisy electrical vestibular stimulation

Active subthreshold noisy electrical vestibular stimulation is delivered using the Neurvesta system (Neursantys Inc.) through two mastoid electrodes and two electrodes on the back of the neck, with the collar resting on the shoulders. Sessions are supervised and performed seated for 20 minutes, three times weekly for six weeks, totaling 18 sessions. The course takes place during exercise weeks 1 to 6 or 7 to 12. Stimulation profile: +/- 0.35 mA (0.7 peak-to-peak) with a bandwidth of 0.001-300 Hz for 20 minutes.

OTHER

Sham device

Sham uses the same skin preparation, four electrodes, collar power-on and app connection as active treatment, but stimulation is not started and no electrical current is delivered. The participant remains seated for 20 minutes while a separate timer is used. Staff remain present and record the session in the study log. Sessions occur three times weekly for six weeks, totaling 18 sessions, during exercise weeks 1 to 6 or 7 to 12.

Locations (1)

Bethany Chapel

Calgary, Alberta, Canada