Balance Disorder
Conditions
Brief summary
The purpose of this study is to develop a vestibular interventional approach using stochastic vestibular stimulation (SVS) through a small, lightweight device, and a comfortable electrode set on the back of the head that stimulates the vestibular system and produces immediate improvements in balance, gait, and overall vestibular function for patients will balance disorder.
Interventions
DEVICEVestibular Intervention via Portable Electrical Stimulator (VIPES) system
A small, lightweight device able to deliver stochastic vestibular stimulation (SVS) using a comfortable electrode set on the back of the head as well as other proven modes of galvanic vestibular stimulation (GVS) related vestibular correction when required to mitigate motion sickness or provide auxiliary vestibular cueing.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participants must be able to consent to participate themselves. * Must be able to attend in-person sessions at the Mayo Aerospace Medicine and - Vestibular Research Laboratory in Scottsdale, AZ. * No racial/ethnic groups will be excluded. * All participants must be fluent speakers of English.
Exclusion criteria
* Presence of peripheral vestibulopathy (cleared by Dix-Hallpike, vHIT as part of clinical evaluation). * Women who are pregnant. * Inability to complete testing (e.g., severe symptom burden, inability to stand unassisted).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Balance Performance | Through study completion, approximately 1.5 hours | Change in balance performance during balance testing by measuring the center of gravity sway (degrees per second) across tested levels of GVR amplitude and control condition. |
Countries
United States
Participant flow
Pre-assignment details
Total of 23 participants were enrolled to receive all interventions; however, the order the intervention was received was randomized. All subjects completed all study visits/interventions.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Stochastic Vestibular Stimulation (SVS) and Control Condition All subjects will perform standard clinical testing for balance and gait without SVS and while wearing the Vestibular Intervention via Portable Electrical Stimulator (VIPES) system. The SVS device will be active throughout the testing at the respective current levels (i.e., 0.2mA to 1 mA at 0.2 mA increments).
Vestibular Intervention via Portable Electrical Stimulator (VIPES) system: A small, lightweight device able to deliver stochastic vestibular stimulation (SVS) using a comfortable electrode set on the back of the head as well as other proven modes of galvanic vestibular stimulation (GVS) related vestibular correction when required to mitigate motion sickness or provide auxiliary vestibular cueing. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | All Participants Stochastic Vestibular Stimulation (SVS) and Control Condition | — |
|---|---|---|
| Age, Continuous | 31.4 years STANDARD_DEVIATION 9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 23 participants | — |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 | 0 / 23 | 0 / 23 |
Outcome results
Primary
Change in Balance Performance
Change in balance performance during balance testing by measuring the center of gravity sway (degrees per second) across tested levels of GVR amplitude and control condition.
Time frame: Through study completion, approximately 1.5 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Condition | Change in Balance Performance | Eye Open Firm Surface | 0.52 degrees per second | Standard Deviation 0.84 |
| Control Condition | Change in Balance Performance | Eye Closed Firm Surface | 0.63 degrees per second | Standard Deviation 0.81 |
| Control Condition | Change in Balance Performance | Eye Open Foam Surface | 0.91 degrees per second | Standard Deviation 1.12 |
| Control Condition | Change in Balance Performance | Eye Closed Foam Surface | 1.36 degrees per second | Standard Deviation 0.97 |
| 0.33 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Closed Foam Surface | 1.49 degrees per second | Standard Deviation 1.58 |
| 0.33 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Open Foam Surface | 0.73 degrees per second | Standard Deviation 0.58 |
| 0.33 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Closed Firm Surface | 0.55 degrees per second | Standard Deviation 0.69 |
| 0.33 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Open Firm Surface | 0.42 degrees per second | Standard Deviation 0.34 |
| 0.67 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Open Foam Surface | 0.87 degrees per second | Standard Deviation 0.77 |
| 0.67 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Closed Foam Surface | 1.47 degrees per second | Standard Deviation 1.23 |
| 0.67 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Closed Firm Surface | 0.73 degrees per second | Standard Deviation 1.19 |
| 0.67 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Open Firm Surface | 0.51 degrees per second | Standard Deviation 0.79 |
| 1 Milliamps (mA)Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Closed Foam Surface | 1.47 degrees per second | Standard Deviation 1.32 |
| 1 Milliamps (mA)Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Open Firm Surface | 0.48 degrees per second | Standard Deviation 0.57 |
| 1 Milliamps (mA)Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Closed Firm Surface | 0.58 degrees per second | Standard Deviation 0.69 |
| 1 Milliamps (mA)Stochastic Vestibular Stimulation (SVS) Condition | Change in Balance Performance | Eye Open Foam Surface | 0.76 degrees per second | Standard Deviation 0.47 |