Trial Outcomes & Findings for Vestibular Intervention Via Portable Electrical Stimulator (VIPES) (NCT NCT04968197)
NCT ID: NCT04968197
Last Updated: 2024-06-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Through study completion, approximately 1.5 hours
Results posted on
2024-06-13
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
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Overall Study
STARTED
|
23
|
|
Overall Study
Control Condition
|
23
|
|
Overall Study
0.33mA Stochastic Vestibular Stimulation
|
23
|
|
Overall Study
0.67mA Stochastic Vestibular Stimulation
|
23
|
|
Overall Study
1mA Stochastic Vestibular Stimulation
|
23
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants Stochastic Vestibular Stimulation (SVS) and Control Condition
n=23 Participants
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.
|
|---|---|
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Age, Continuous
|
31.4 years
STANDARD_DEVIATION 9.0 • n=23 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Through study completion, approximately 1.5 hoursChange 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.
Outcome measures
| Measure |
Control Condition
n=23 Participants
Subjects will perform standard clinical testing for balance and gait without stochastic vestibular stimulation (SVS)
|
0.33 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition
n=23 Participants
Subjects will perform standard clinical testing for balance and gait 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.
|
0.67 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition
n=23 Participants
Subjects will perform standard clinical testing for balance and gait 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.
|
1 Milliamps (mA)Stochastic Vestibular Stimulation (SVS) Condition
n=23 Participants
Subjects will perform standard clinical testing for balance and gait 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.
|
|---|---|---|---|---|
|
Change in Balance Performance
Eye Open Firm Surface
|
0.52 degrees per second
Standard Deviation 0.84
|
0.42 degrees per second
Standard Deviation 0.34
|
0.51 degrees per second
Standard Deviation 0.79
|
0.48 degrees per second
Standard Deviation 0.57
|
|
Change in Balance Performance
Eye Closed Firm Surface
|
0.63 degrees per second
Standard Deviation 0.81
|
0.55 degrees per second
Standard Deviation 0.69
|
0.73 degrees per second
Standard Deviation 1.19
|
0.58 degrees per second
Standard Deviation 0.69
|
|
Change in Balance Performance
Eye Open Foam Surface
|
0.91 degrees per second
Standard Deviation 1.12
|
0.73 degrees per second
Standard Deviation 0.58
|
0.87 degrees per second
Standard Deviation 0.77
|
0.76 degrees per second
Standard Deviation 0.47
|
|
Change in Balance Performance
Eye Closed Foam Surface
|
1.36 degrees per second
Standard Deviation 0.97
|
1.49 degrees per second
Standard Deviation 1.58
|
1.47 degrees per second
Standard Deviation 1.23
|
1.47 degrees per second
Standard Deviation 1.32
|
Adverse Events
Control Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.33 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.67 Milliamps (mA) Stochastic Vestibular Stimulation (SVS) Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1 Milliamps (mA)Stochastic Vestibular Stimulation (SVS) Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place