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

Conditions

• Vestibulopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Accepted

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.
• Sham Comparator — DEVICE
  No current is applied during EVS treatment

Study Details

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.

Key Dates

Start date

Jan 20, 2025

Status verified

Feb 2025

Primary completion

Feb 28, 2027

Completion

Feb 28, 2027

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Electrical vestibular stimulation treatment
  Participants in this Arm will receive active treatment with swsEVS applied
• Sham Comparator: Sham stimulation treatment
  Participants in this Arm will receive sham treatment with no swsEVS applied.

Primary Outcome Measure

Postural Sway Measure of Balance Performance [ Time Frame: From enrollment through the end of treatment and up to 6 months post treatment ]

Central Contacts

• Ryan M Peters, PhD
  403-606-5506
  [email protected]
• John D Ralston, PhD
  650-2158-418
  [email protected]

Locations (2)

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