Therapeutic Effects of Electrical Vestibular Stimulation (EVS) on Balance and Gait
ConditionVestibulopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNeursantys Inc
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
electrical vestibular stimulation (EVS)
DeviceEVS 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
DeviceNo current is applied during EVS treatment
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Electrical vestibular stimulation treatmentExperimental treatment 1 intervention
Group B: Sham stimulation treatmentSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment through the end of treatment and up to 6 months post treatment2
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
Time frame
From enrollment through the end of treatment and up to 6 months post treatment3
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.
Time frame
From enrollment through the end of treatment and up to 6 months post treatment4
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.
Time frame
From enrollment through the end of treatment and up to 6 months post treatmentSecondary outcomes
1
Symbol Digit Matching Task (SDMT) Measure of Cognitive Performance
This secondary outcome variable will measure changes in cognitive performance scores before vs. after the 18-session EVS intervention period of the study. For assessment of cognitive performance, the measurement scale will be the Symbol Digit Matching Task (SDMT). SDMT quantifies the number of symbol-digit matching pairs the participant completes in 90 seconds.
Time frame
From enrollment through the end of treatment and up to 6 months post treatment2
Montreal Cognitive Assessment (MoCA) of Cognitive Performance
This secondary outcome variable will measure changes in cognitive performance scores before vs. after the 18-session EVS intervention period of the study. For assessment of cognitive performance, the measurement scale will be the Montreal Cognitive Assessment (MoCA). The MoCA is scored on a 0 to 30 scale.
Time frame
From enrollment through the end of treatment and up to 6 months post treatmentOther outcomes
1
Migraine Disability Assessment (MIDAS) of Headaches
For participants suffering from headaches, this tertiary outcome variable will determine if there are any changes after vs. before the 18-session EVS intervention period. For assessments of headaches, the measurement scales will be the Migraine Disability Assessment (MIDAS). The MIDAS is scored by totaling the number of days indicated by the user across a 5-item questionnaire.
Time frame
From enrollment through the end of treatment and up to 6 months post treatment2
Dizziness Handicap Inventory (DHI) of Dizziness
For participants suffering from dizziness, this tertiary outcome variable will determine if there are any changes after vs. before the 18-session EVS intervention period. For assessments of dizziness, the measurement scale will be the Dizziness Handicap Inventory (DHI). The DHI is scored by totaling the value indicated by the subject (0 = No, 2 = Sometimes, 3 = Always) across a 25-item questionnaire.
Time frame
From enrollment through the end of treatment and up to 6 months post treatmentSponsors and contacts
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Source ClinicalTrials.gov