An interventional study of Noisy electrical vestibular stimulation and Sham device in Health Aging and Balance, sponsored by University of Calgary. Not yet recruiting at 1 site in Canada. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University of Calgary · Not applicable, Interventional, and Prevention
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.
The study will examine whether vestibular stimulation complements exercise-related improvements in balance and physical function. Because both randomized groups participate in the same exercise program, the treatment comparison will estimate the additional effect of active noisy electrical vestibular stimulation (nEVS) relative to sham within that program. Changes across the full exercise program will provide additional context for interpreting the treatment findings.
The randomized trial is embedded within the RISE STRONG program. Participation in the trial will require research consent separate from consent for program services. Individuals who decline or discontinue trial participation may continue to access the exercise program. Exercise participants who are not randomized will not form part of the active-versus-sham comparison.
Randomization and masking Participants will be randomized individually in a 1:1 ratio using a computer-generated sequence with randomly varying block sizes, stratified by the planned stimulation window: exercise weeks 1-6 or 7-12. An independent researcher will generate and securely maintain the allocation sequences. Upcoming assignments will be concealed from recruiting staff, and allocation will be released only after research consent, eligibility confirmation and pretreatment assessments are complete.
Participants and investigators will remain masked to treatment assignment. A separate trained treatment operator may know the assignment to administer the allocated procedure. Access to allocation information will be restricted according to study role. Both groups will use the same equipment setup and scheduled session duration. Participants' perceptions of allocation will be assessed before planned disclosure, as specified in the registered masking outcome.
Integration with the exercise program Exercise will include strength and power, balance, mobility, flexibility and walking activities. Initial exercise placement will reflect baseline physical performance and safety review. Qualified staff will adapt activities and document progression according to each participant's ability and tolerance. Exercise placement and progression will be independent of stimulation assignment.
Each participant will remain in the assigned active or sham group throughout the stimulation course. The early and late stimulation windows are scheduling strata within a parallel-group trial; participants will not cross over between active and sham treatment. Stimulation will be administered seated under supervision, with visits coordinated with exercise attendance where possible.
Assessment timing and consistency Treatment-relative time and exercise-program time will be recorded separately. Treatment week 0 is the pretreatment assessment before the first assigned session. Physical assessments are scheduled at treatment weeks 0, 3 and 6, while the registered patient-reported and cognitive outcomes are assessed before and after the six-week course. The week-6 assessment is the end-of-course endpoint; the week-3 assessment characterizes the interim response.
This schedule will apply to both stimulation windows. For participants treated during exercise weeks 1-6, exercise-program week 12 represents later follow-up after stimulation. For participants treated during exercise weeks 7-12, it coincides with treatment completion. Program-baseline and week-12 observations will therefore be distinguished from treatment-relative observations in the dataset and analyses. Questionnaire and cognitive testing will be scheduled around the assigned stimulation course rather than relying solely on the beginning and end of the exercise program.
Trained assessors will use standardized instructions, sensor placement and scoring procedures across visits. Footwear, walking aids, test setup and assistance will be kept consistent where feasible, and necessary changes will be documented. Rest and close guarding will be provided during physical assessments. Incomplete tests, early termination, use of external support and technical recording failures will be documented separately. Questionnaire assistance will follow the relevant instrument instructions, and administration mode will be recorded.
Safety and treatment delivery Staff will review current symptoms and relevant health changes before study procedures and inspect electrode sites before stimulation. The treatment operator will remain with the participant during each session. Stimulation will be paused for discomfort or dizziness and stopped when indicated; it will not resume while symptoms persist. Physical tasks may be modified or deferred when they cannot be completed safely. Participants will receive study contact information for concerns arising between visits.
Session records will distinguish attendance from completion of the assigned treatment and document interruptions, device problems, modifications and reasons for discontinuation. Adverse events will be monitored throughout the registered surveillance period and reviewed alongside treatment exposure and exercise attendance. Participants who discontinue stimulation may continue outcome assessments if they agree to further research follow-up.
Analysis and data quality The primary analysis will follow the intention-to-treat principle, retaining participants in their randomized groups. End-of-course Phybrata power will be compared using analysis of covariance, adjusting for pretreatment Phybrata power and the assigned stimulation window. Changes from pretreatment will also be summarized. Treatment-effect estimates will be reported with 95% confidence intervals.
Secondary continuous outcomes will be evaluated using appropriate baseline-adjusted models. Repeated physical assessments may additionally be examined using mixed-effects models with participant-level random intercepts and treatment, time and treatment-by-time terms. Categorical and ordinal outcomes will be analyzed using methods appropriate to their measurement scales. Secondary analyses will be interpreted as exploratory, and attendance, treatment completion and safety findings will be summarized descriptively by assigned group. Whole-program changes will be interpreted separately from the randomized treatment comparison.
The statistical analysis plan will specify the balance-condition analysis, processing and trial-aggregation rules, missing-data methods and any sensitivity analyses before comparative treatment results are examined. Missing observations and their reasons will be summarized by group and visit. Data-quality procedures will include checks for completeness and plausible values, documentation of protocol deviations, and version control for processing and analysis.
Research records will use coded study identifiers, with direct identifiers and the linkage key held separately under restricted access. Previously collected program or company-held data will remain distinguishable from prospectively collected trial data and will be used for research only under the applicable consent and ethics permissions. Results will be reported in aggregate, with prespecified and exploratory analyses identified separately.
University of Calgary is the lead sponsor of 699 studies on the registry; 192 are open to participants now.
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Participants receive active noisy electrical vestibular stimulation (nEVS) for 20 minutes per session, three sessions weekly for six weeks, totaling 18 sessions. The assigned course takes place during exercise weeks 1 to 6 or 7 to 12. Participants also attend the common 12-week RISE STRONG exercise program, with two supervised classes weekly lasting approximately 35 to 45 minutes and an individualized home-exercise plan.
Device: Noisy electrical vestibular stimulation
Participants undergo the same preparation, electrode placement, collar setup and app connection as the active group, but electrical stimulation is not started. They remain seated for 20 minutes using a separate timer. Sham sessions occur three times weekly for six weeks, totaling 18 sessions, during exercise weeks 1 to 6 or 7 to 12. Participants also receive the same 12-week RISE STRONG exercise program and individualized home-exercise plan.
Other: Sham device
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.
Also known as: Neurvesta, galvanic vestibular stimulation
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.
Phybrata power
Change in Phybrata power from pretreatment to completion of the 6-week course, calculated from head-mounted accelerometers recording a 60-second standing assessment under different standing balance conditions (mCTSIB; floor yes open, floor eyes closed, compliant surface eyes open, compliant surface eyes closed). Values are expressed in watts taking the sum of the squared acceleration of the tri-axial accelerometer multiplied by a time scaling factor. Lower values indicate less sway, a negative change indicates improved performance. The primary comparison is active vs sham nEVS, adjusted for pretreatment performance.
Time frame: At the start of the 6-week intervention (week 0), midpoint (week 3), and end of the 6-week intervention (week 6)
Gait speed
Change in overground gait speed in metres per second over a 25-foot course. Speed equals distance divided by walking time. Higher values indicate faster walking.
Time frame: At the start of the 6-week intervention (week 0), midpoint (week 3), and end of the 6-week intervention (week 6)
Timed-up-and-go
Change in time, in seconds, to stand from a chair, walk 3 metres at a self selected pace, turn, return to the chair, and sit. Usual walking aids are permitted and recorded. Lower completion time indicates faster functional mobility.
Time frame: At the start of the 6-week intervention (week 0), midpoint (week 3), and end of the 6-week intervention (week 6)
Short Physical Performance Battery total score
Change in short physical performance battery (SPPB) total score. Standardized standing balance, usual-pace walking, and repeated chair0rise components contribute 0-4 points, giving a total score from 0-12. Higher scores indicate better physical performance.
Time frame: At the start of the 6-week intervention (week 0), midpoint (week 3), and end of the 6-week intervention (week 6)
Grip strength
Change in hand-grip strength in kilograms, measured using acalibrated hand dynameter in a standardized seated position. Two valid attempts are recorded. The participants best score is used for analysis. Higher values indicate greater grip strength.
Time frame: At the start of the 6-week intervention (week 0), midpoint (week 3), and end of the 6-week intervention (week 6)
PROMIS Global Physical Health Score
Change in physical health assessed using the PROMIS Global Health v1.2 questionnaire. The four-item physical health raw score will be converted to a T-score using the official scoring tables. T-scores range from 16.2 to 67.7, with higher scores indicating better physical health. Change will be calculated as the end-of-course score minus the pretreatment score; positive values indicate improvement
Time frame: Immediately before the first EVS or sham session and at completion of the six-week course.
PROMIS Global Mental Health Score
Change in mental health assessed using the PROMIS Global Health v1.2 questionnaire. The four-item mental health raw score will be converted to a T-score using the official scoring tables. T-scores range from 21.2 to 67.6, with higher scores indicating better mental health. Change will be calculated as the end-of-course score minus the pretreatment score; positive values indicate improvement.
Time frame: Immediately before the first EVS or sham session and at completion of the six-week course.
Distribution of EQ 5D 5L Mobility Response Levels
Number and percentage of participants in each response level of the EQ-5D-5L mobility dimension at each assessment. The dimension concerns walking about. Levels range from 1 to 5, with level 1 indicating no problems and level 5 the most severe problems or inability. Lower levels indicate fewer problems. Each dimension is reported separately.
Time frame: Immediately before the first EVS or sham session and at completion of the six-week course.
Distribution of EQ 5D 5L Self Care Response Levels
Number and percentage of participants in each response level of the EQ-5D-5L self care dimension at each assessment. The dimension concerns washing or dressing. Levels range from 1 to 5, with level 1 indicating no problems and level 5 the most severe problems or inability. Lower levels indicate fewer problems. Each dimension is reported separately.
Time frame: Immediately before the first EVS or sham session and at completion of the six-week course
Distribution of EQ 5D 5L Usual Activities Response Levels
Number and percentage of participants in each response level of the EQ-5D-5L usual activities dimension at each assessment. The dimension concerns usual daily activities. Levels range from 1 to 5, with level 1 indicating no problems and level 5 the most severe problems or inability. Lower levels indicate fewer problems. Each dimension is reported separately.
Time frame: Immediately before the first EVS or sham session and at completion of the six-week course
Distribution of EQ 5D 5L Pain or Discomfort Response Levels
Number and percentage of participants in each response level of the EQ-5D-5L pain or discomfort dimension at each assessment. The dimension concerns pain or discomfort. Levels range from 1 to 5, with level 1 indicating no problems and level 5 the most severe problems or inability. Lower levels indicate fewer problems. Each dimension is reported separately.
Time frame: Immediately before the first EVS or sham session and at completion of the six-week course
Distribution of EQ 5D 5L Anxiety or Depression Response Levels
Number and percentage of participants in each response level of the EQ-5D-5L anxiety or depression dimension at each assessment. The dimension concerns anxiety or depression. Levels range from 1 to 5, with level 1 indicating no problems and level 5 the most severe problems or inability. Lower levels indicate fewer problems. Each dimension is reported separately.
Time frame: Immediately before the first EVS or sham session and at completion of the six-week course
Mean Change in M2C2 Symbol Search Response Time
Change in processing speed assessed using the Mobile Monitoring of Cognitive Change (M2C2) Symbol Search task. Participants identify matching symbol pairs as quickly and accurately as possible. The participant-level score is the median response time, in milliseconds, across valid correct test trials. Lower values indicate faster processing speed. Change will be calculated as the end-of-course score minus the pretreatment score; negative values indicate improvement.
Time frame: Immediately before the first EVS or sham session and at completion of the six-week course.
Mean Change in M2C2 Grid Memory Spatial Recall Error
Change in visuospatial working memory assessed using the M2C2 Grid Memory task. Participants recall previously displayed dot locations following a brief distraction task. The participant-level score is the mean trial-level Euclidean distance error between recalled and original dot locations. A score of zero indicates no spatial recall error; lower values indicate better performance. Change will be calculated as the end-of-course score minus the pretreatment score; negative values indicate improvement.
Time frame: Immediately before the first EVS or sham session and at completion of the six-week course.
Mean Change in M2C2 Color Dots Recall Accuracy
Change in visual working memory and color-location binding assessed using the M2C2 Color Dots task. Participants recall the colors and locations of previously presented dots. Accuracy will be calculated as the number of correct recall responses divided by the total number of scorable recall responses across the color and location phases, multiplied by 100, using the task version's scoring criteria. Scores range from 0% to 100%, with higher scores indicating better performance. Change will be calculated as the end-of-course percentage minus the pretreatment percentage; positive changes indicate improvement.
Time frame: Immediately before the first EVS or sham session and at completion of the six-week course.
Mean Change in M2C2 Color Shapes Accuracy
Change in visual working memory and color-shape binding assessed using the M2C2 Color Shapes task. Participants identify whether previously presented color-shape combinations remain unchanged or have changed. Accuracy will be calculated as the number of correct responses divided by the total number of scorable test responses, multiplied by 100. Scores range from 0% to 100%, with higher scores indicating better performance. Change will be calculated as the end-of-course percentage minus the pretreatment percentage; positive changes indicate improvement.
Time frame: Immediately before the first EVS or sham session and at completion of the six-week course.
Number of Assigned EVS or Sham Sessions Completed
Number of assigned sessions completed by each participant during the six-week course, from 0 to 18. Higher counts indicate greater attendance.
Time frame: From the first assigned session through completion of the six-week EVS or sham course
Number of Exercise Classes Attended
Number of supervised RISE STRONG classes attended by each trial participant during the 12-week program, from 0 to 24. Higher counts indicate greater attendance. Attendance is recorded in session logs.
Time frame: From exercise-program baseline through exercise-program week 12
Number of Participants With at Least One Adverse Event
Number of participants experiencing at least one adverse event during the defined surveillance period, reported by assigned group. Events are recorded with onset, severity, seriousness, relatedness to study procedures, action taken and outcome.
Time frame: From EVS-trial consent through exercise-program week 12
Percentage of Participants Correctly Guessing Treatment Allocation
Number of participants whose active-versus-sham allocation guess matches their assigned group divided by the number providing a guess, multiplied by 100, reported by assigned group.
Time frame: Exercise-program week 12, before allocation disclosure
Plan to share: Undecided — Raw data will be provided upon reasonable request.
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