Vestibular Intervention Via Portable Electrical Stimulator (VIPES)
Phase: NA
Conditions: Balance Disorder
Sponsor: Mayo Clinic

 
 
Vestibular Intervention Via Portable Electrical 
Stimulator (VIPES)   
 
NCT04968197 
 
August 18, 2023 

Minimal Risk Protocol Template [IRB 10429.010] 
 
Effective: 9/20/2017 
 
 
 
 
 
 
 
 
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IRB Minimal Risk Protocol Template  
 
General Study Information 
 
Principal Investigator:  Gaurav N. Pradhan, PhD 
    
 
 
 
 
 
 
 
 
Study Title:   Vestibular Intervention via Portable Electrical Stimulator (VIPES)  
 
Protocol version number and date:     Version 2 and August 18th, 2023 
 
Research Question and Aims 
 
Hypothesis: 
The efficacy of stochastic galvanic vestibular stimulation to improve balance and gait performance in 
individuals diagnosed with mild traumatic brain injury or experience vestibular disorders causing dizziness, 
impaired balance, and altered coordination. 
 
Aims, purpose, or objectives: 
To develop a wearable portable stimulator to stimulate the vestibular system and produce immediate 
improvements in balance, gait, and overall vestibular function for patients with balance disorders. 
 
Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):   
The vestibular system is an essential element of human balance, which is critical to proper stance and gait. An 
impaired vestibular system can cause debilitating dizziness or loss of balance leading to dangerous falls and an 
inability to perform normal activities of daily living. Vestibular dysfunction is both a hallmark of acute 
traumatic brain injury (TBI) and also a long-term problem with considerable quality of life effects for those 
experiencing mild TBI (mTBI). Often times, this dysfunction is due to a reduction in the signal from the 
vestibular system to the brain, resulting in a misrepresentation of the balance state of the individual with 
dysfunction. Recent and ongoing research has demonstrated that by boosting the signals produced from the 
vestibular system, these balance issues and the symptoms that go along with them can be alleviated. 
To date, the War on Terror has claimed over 50,000 US casualties, many of which stem from an increase in 
wartime blast threats from improvised explosive devices (IEDs). Between 2000 and 2018, US Military 
personnel had experienced 383,947 cases of TBI, 315,897 of which were classified as mild TBI [1]. Nearly 30% 
of soldiers that are diagnosed with mild traumatic brain injury or worse experience vestibular disorders causing 
dizziness, impaired balance, and altered coordination that prevent their performance in reparative physical 
therapy, impede return to duty, and significantly reduce quality of life. Similarly, as many as 35% of civilian 
adults aged 40 years or older in the United States (~69 million Americans) have experienced some form of 
vestibular dysfunction with a further 4% (8 million) of American adults reporting a chronic problem with 
balance. Symptoms of chronic imbalance can have a significant impact on the ability of a disabled person to 
perform one or more activities of daily living (ADL), a term used for basic necessities such as bathing, dressing, 
or simply getting around inside the home. 
 
Giving attention to this prevalent problem among warfighters and civilians alike, researchers have attempted to 
restore balance through vestibular implants, vibrotactile feedback, tongue placed biofeedback, and vibrating 

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insoles. Of these, the vestibular implant is the only one directly targeting the vestibular system. However, the 
invasive nature of such implants is unwarranted for acute symptoms and is highly risky for an older population 
that is more susceptible to surgical complication. The remaining approaches indirectly stimulate the central 
nervous system (CNS) as opposed to producing actual vestibular sensation. Further, many of the symptoms 
brought on by mTBI are acute in nature, where the vast majority of patients see improvement over a specific 
amount of time. Thus, implants, while highly beneficial for those with chronic vestibular dysfunction, simply do 
not fit a need for the vast majority of cases, revealing an immediate and significant need for a means to provide 
the same vestibular dysfunction correction as an implant via a comfortably worn, non-invasive device. 
 
Recent work has focused on non-invasive electrical stimulation of the vestibular system, historically called 
galvanic vestibular stimulation (GVS), including use of electrical signals comprising filtered random noise, 
known as stochastic vestibular stimulation (SVS). These techniques promise a device that could address a loss 
of vestibular function and improve balance without the aforementioned drawbacks of other systems and the side 
effects of pharmacologic therapy. Complimentary, prior work performed in Aerospace Medicine and Vestibular 
Research Laboratory at Mayo Clinic Arizona has demonstrated several unique modes of transcutaneous 
GVS to: 1) induce a controlled sense of motion when none is present (IRB#: 06-005443), 2) provide directional  
vestibular cueing (IRB#s: 09-003815, 18-005564, 19-003257), and 3) mitigate the debilitating effects of motion  
sickness stemming from decoupling of the vestibular and visual cues (IRB#s: 11-007718, 20-005763) [2, 3].  
Significant work by others has shown that introduction of stochastic vestibular stimulation creates a stochastic  
resonance effect, enhancing the diminished vestibular response in subjects with history of blast injury and  
mTBI. While SVS can help many patients with mTBI related vestibular impairment, other GVS stimulation  
modes may also be required depending on the location and severity of the injury and the nature of the activities  
being undertaken. Thus, a multi-modal vestibular stimulation approach is paramount to addressing the multi- 
variant problem of vestibular dysfunction and reaching the vast majority of patients that experience mTBI  
related symptoms. The proposed Vestibular Intervention via Portable Electrical Stimulator (VIPES) system 
(Figure 1) is a small, lightweight device able to deliver SVS using a comfortable electrode set on the back of the 
head as well as other proven modes of GVS related vestibular correction when required to mitigate motion 
sickness or provide auxiliary vestibular cueing. 
 
 
 
 

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Figure 1: VIPES includes a disposable set of electrodes located behind the ears, which can be integrated 
into a low cost, comfortable, multi-use hearing aid style device that fits behind the ear and reports head 
position/motion for multi-modality control, and a small electronics / battery module that comfortably 
hangs down the users neck. 
 
 
References: 
1. DVBIC. Total (2000-2018 Q1) DoD TBI Worldwide Numbers. 2018 [cited 2019 5/29/2019]; Available from: 
https://dvbic.dcoe.mil/dod-worldwide-numbers-tbi. 
2. Cevette; Michael, Stepanek, Jan, Galea; Anna, Galvanic vestibular stimulation system and method of use for 
simulation, directional cueing, and alleviating motion-related sickness. US Patent 8,718,796. 
3. Cevette, M.J., et al., Oculo-vestibular recoupling using galvanic vestibular stimulation to mitigate simulator 
sickness. Aviat Space Environ Med, 2012. 83(6): p. 549-55. 
4. Wrisley, D.M. and S.L. Whitney, The effect of foot position on the modified clinical test of sensory 
interaction and balance. Archives of physical medicine and rehabilitation, 2004. 85(2): p. 335-338. 
5. Massingale, S., et al., Comparison of uninjured and concussed adolescent athletes on the concussion balance 
Test (COBALT). Journal of neurologic physical therapy, 2018. 42(3): p. 149-154. 
6. Podsiadlo, D. and S. Richardson, The timed “Up & Go”: a test of basic functional mobility for frail elderly 
persons. Journal of the American geriatrics Society, 1991. 39(2): p. 142-148. 
 
 
Study Design and Methods 
 
Methods:  Describe in lay terms, completely detailing the research activities that will be conducted by Mayo 
Clinic staff under this protocol. 
 
Consent: Consent forms include typical notifications of the sponsor and purpose of the study, identification of 
any risks in the minimal-risk protocol, discussion of privacy dimensions of the study and description of the 
amount and compensation structure schedule. We brief participants of their right to opt out of the study at any 

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time and for any reason. We include consent forms in the attached draft IRB that are patterned after similar 
forms used in other persistent sensor wear studies the Mayo team has conducted. 
 
Compensation: Remuneration of $150 is proposed to fairly reimburse participants for the time involved. 
 
Protocol:  
In this repeated-measures design, each patient will be tested in a “Control”, or baseline condition, and a pre-
determined stimulation level of “Stochastic Vestibular Stimulation (SVS)” up to 1mA. In the Control condition: 
the entire testing will be conducted with the system worn but without SVS application (i.e., 0mA). The patient 
will be instrumented with electrodes without turning on the SVS device throughout the testing. In the SVS 
condition: The SVS device will be active throughout the testing at the respective current level. The test will be 
performed for a singular, pre-determined, GVS amplitude up to 1mA. The order of the conditions will be 
randomized across subjects. The details of testing (single visit) are summarized below. 
 
Equipment: 
The VIPES system that provides SVS is a small wearable device in order to improve the function of an 
individual’s vestibular system that has been adversely affected their balance due to head injuries and mild TBI. . 
In particular, VIPES is designed to provide electrical stimulus comprising random noise in a low frequency 
band (0 to 5Hz maximum) below the level of perception by the subject. The VIPES system consists of the four 
electrodes (two behind each ear) similar to our commercial galvanic stimulator (Good Vibrations Engineering 
Ltd, King City, ON; used in the previous IRB approved projects – IRB #s:  20-005763, -19-003257, 18-005564, 
14-003906, 11-007718, 09-003815). The stimulator can bidirectionally deliver the electrical stimulation and 
receive information about the amplitude delivered accounting for skin impedance. Bertec Portable Essential’s 
dual-balance plate balance system (previously IRB approved in IRB 20-005763) used for balance testing is 
clinically used in Mayo Clinic Arizona. 
 
Testing: 
Following documentation of consent for study participation, participants will complete pre-testing 
questionnaires and medical history evaluations. Subjects will don the VIPES device and the research team will 
verify the system is set to 0mA and participants will then be given a direction and timeframe to walk in the 
Mayo Clinic space for up to 10 minutes before returning to the laboratory, as a means of establishing baseline 
gait, balance, stability, and pace to be measured by an incorporated accelerometer (sway score; deg/s). Once 
returned, participants will be allotted a 5-minute resting period prior to beginning the ‘Condition’ testing. 
Subjects will complete a series of balance tests to establish and describe a range of balance performance. The 
Modified Clinical Test of Sensory Interaction and Balance (mCTSIB) [4], and COBALT Balance test [5] are 
measures of standing balance that increase in difficulty. These metrics will be included for the rationales noted 
below, but also to better describe the wide ability of balance function in individuals with balance disorder. 
Subjects will be randomized for balancing testing condition order and will complete the mCTSIB and COBALT 
with the system providing a known amount of electrical stimulus, as well as with the system providing 0mA, 
but will be blinded for which condition is taking place. Participants will be permitted to leave and walk 
normally about the premises with the VIPES system now provided the known-stimulation dose.  A member of 
the investigational team will accompany the subjects for the duration of their walking. Subjects will return after 
~30-45 mins and will be allotted an additional 5-minute resting period. Subjects will complete the mCTSIB and 
COBALT balance tests with the system delivering stimulation. Once completed, the VIPES system will be 

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removed and participants will answer the Post-Testing Questionnaires before finishing the study day and being 
provided remuneration. The details of testing are summarized as follows:  
 
 
Visit: 
Duration 
Consent & Pre-Testing Questionnaire(s) 
• Post-concussion symptoms scale 
• Demographics & Medical History 
 
10 mins 
Baseline Walk 
• Participants will walk with the system at 0mA, as is normal, for up 
to 10 minutes to establish baseline gait  
• Subject will rest for approximately 5 minutes. 
 
15 mins 
COBALT Balance Test: 
Device:  Bertec Portable Essential’s dual-balance plate balance system 
(https://www.bertec.com/bertec-balance-advantage-systems) 
 
Rationale: COBALT is a balance test commonly used to evaluate 
individuals post-concussion.  This test protocol places high demand on the 
visual and vestibular systems that is not provided by traditional balance 
tests.  These higher demand conditions improve sensitivity in detecting 
balance dysfunction in those post-concussion. 
 
The test will be performed for a given SVS amplitude up to 1mA and 0mA, 
and will be randomized for each subject.  
 
Two 20-seconds trial for each of the following conditions/surfaces: 
 
On Firm Surface: 
• Head Shake 
• Visual Motion Sensitivity 
 
On Foam Surface: 
• Head Shake 
• Visual Motion Sensitivity 
 
10 mins 
Modified Clinical Test of Sensory Integration on Balance (mCTSIB): 
Device:  Bertec Portable Essential’s dual-balance plate balance system 
(https://www.bertec.com/bertec-balance-advantage-systems) 
 
Rationale: mCTSIB is a balance test commonly used to evaluate individuals 
of all ages post-concussion.  This test protocol assesses how well an 
individual uses sensory input when one or more sensory systems are 
10 mins 

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compromised. This protocol is commonly used to evaluate individuals post-
concussion to describe static balance ability. 
 
The test will be performed for a given SVS amplitude up to 1mA and 0mA, 
and will be randomized for each subject.  
 
Three 10-second trials for each of the following conditions: 
 
• Standard (eyes open on firm surface) 
• Proprioception (eyes closed on firm surface) 
• Vision (eyes open on foam surface) 
• Vestibular (eye closed on foam surface) 
 
SVS Condition Walk 
• Participants will walk with the system at 0mA, as is normal, for up 
to 45 minutes to establish baseline gait  
• Subject will rest for approximately 5 minutes. 
 
50 mins 
Repeat mCTSIB and COBALT  
 
20 mins 
Post-testing Questionnaires: 
 
• Clinical Motion Sickness Symptom Severity 
• System Usability Scale (SUS) 
• Subjective Clinical Feedback 
 
5 mins 
 
 
 
Subject Information 
 
Target accrual is the proposed total number of subjects to be included in this study at Mayo Clinic. A “Subject” 
may include medical records, images, or specimens generated at Mayo Clinic and/or received from external 
sources.    
 
Target accrual: 40 participants 
 
Subject population (adults, groups):   Patients – 1) diagnosed with a balance disorder and/or having sustained a 
concussion and/or mild traumatic brain injury (mTBI), 2) Currently being evaluated at Mayo Clinic Arizona, 3) 
self-reported imbalance,  
 
 
Inclusion Criteria: For our purposes, participants must be able to consent to participate themselves and be 18 to  
70 years of age and must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular  

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Research Laboratory in Scottsdale, AZ. No racial/ethnic groups will be excluded, although all participants must  
be fluent speakers of English 
 
Exclusion Criteria: 1) Presence of peripheral vestibulopathy (cleared by Dix-Hallpike, vHIT as part of clinical  
evaluation), 2) women who are pregnant, and 3), inability to complete testing (e.g., severe symptom burden,  
inability to stand unassisted).  
 
 
 
Biospecimens 
 
Collection of blood samples. When multiple groups are involved copy and paste the appropriate section below 
for example repeat section b when drawing blood from children and adults with cancer.  
 
a. From healthy, non-pregnant, adult subjects who weigh at least 110 pounds. For a minimal risk 
application, the amount of blood drawn from these subjects may not exceed 550ml in an 8 week period 
and collection may not occur more frequently than 2 times per week. 
Volume per blood draw: __N/A___ml   
Frequency of blood draw (e.g. single draw, time(s) per week, per year, etc.) _N/A_______ 
 
b. From other adults and children considering age, weight, and health of subject. For a minimal risk 
application, the amount of blood drawn from these subjects may not exceed the lesser of 50 ml or 3 ml 
per kg in an 8 week period, and collection may not occur more frequently than 2 times per week.   
Volume per blood draw: _N/A____ml 
Frequency of blood draw (e.g. single draw, time(s) per week, per year, etc.) _N/A________  
 
Prospective collection of biological specimens other than blood: ___N/A________________________ 
 
 
Review of medical records, images, specimens  
 
 
Check all that apply (data includes medical records, images, specimens).  
 
  Only data that exists before the IRB submission date will be collected.   
 
Date Range for Specimens and/or Review of Medical Records:   
Examples: 01/01/1999 through 12/31/2015, or all records through mm/dd/yyyy.  
 
Note: The Date Range must include the period for collection of baseline data, as well as follow-up data, 
if applicable. 
 

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  The study involves data that exist at the time of IRB submission and data that will be generated after IRB 
submission. Include this activity in the Methods section.  
Examples 
• The study plans to conduct a retrospective chart review and ask subjects to complete a questionnaire.  
• The study plans to include subjects previously diagnosed with a specific disease and add newly 
diagnosed subjects in the future.  
 
  The study will use data that have been collected under another IRB protocol. Include in the Methods section 
and enter the IRB number from which the research material will be obtained. When appropriate, note when 
subjects have provided consent for future use of their data and/or specimens as described in this protocol.  
 
Enter one IRB number per line, add more lines as needed 
 
 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 
 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 
 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 
 
Data Analysis 
 
 
Power analyses may not be appropriate if this is a feasibility or pilot study, but end-point analysis plans are 
always appropriate even if only exploratory. Provide all information requested below, or provide justification if 
not including all of the information.  
 
 
Data Analysis Plan:  
 
 
We will use repeated measures ANOVA to examine changes in balance performance during balance testing by 
measuring sway score (i.e., sway angular velocity, deg/s) across tested levels of GVR amplitude and control 
condition. Sample size estimates are based on: (1) the expected variability (s2) in the response parameters, (2) 
the alpha (a, type I) error level, or probability of incorrectly concluding there is an effect when responses are 
equivalent, (3) the magnitude of the effects to be detected between the means (μ1, μ2), and (4) the certainty 
(statistical power, 1- b) with which the effect is to be detected. Sample sizes can be calculated based on the 
expected standardized differences (Δ) between conditions. 
 
Power Statement:   
Standardized mean differences of 0.08 deg/s on firm surface and 0.17 deg/s on foam surface will be considered 
operationally relevant effect sizes for balance performance comparison based on previous balance testing 
protocols using the COBALT testing [5]. Based on the equation above, we will have 80% statistical power to 
detect standardized mean differences (two-sided tests) of 0.08 (firm surface) and 0.17 (foam surface) with an 

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alpha error level of 0.05 with a sample of 22 participants. A target of at least 30 participants is requested to 
account for incomplete data sets. 
 
 
Endpoints 
Primary: Our project will deliver a vestibular interventional approach using stochastic vestibular stimulation 
(SVS) through a small, lightweight, and portable device housed in a body-worn torso strap that feeds into a 
comfortable electrode set on the back of the head (on the mastoid process) to deliver continuous and dose-
specific stimulation to the vestibular system and produce immediate improvements in balance, gait, and overall 
vestibular function.