Study on the Effects of Electrical Vestibular Stimulation EVS to Improve Balance and Walking in Adults Aged 18 to 100

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.

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