A Pilot Project to Investigate the Use of an External Vestibular Prosthesis Potential to Improve Clinical Management of Chronic Subjective Dizziness (CSD)
Phase: NA
Conditions: Dizziness Chronic
Sponsor: Mayo Clinic

A pilot project to investigate 
the use of an external 
vestibular prosthesis potential 
to improve clinical 
management of Chronic 
Subjective Dizziness (CSD) 
NCT# 02048670 
July 22, 2013 

Minimal Risk Protocol Template [IRB 10429.004] 
Effective August 28, 2012 
 
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IRB Minimal Risk Protocol Template 
General Study Information 
Principal Investigator:  Jeffrey P. Staab, M.D. 
Study Title:    A pilot project to investigate the use of an external vestibular prosthesis potential to 
improve clinical management of Chronic Subjective Dizziness (CSD) 
Protocol version number and date:    01, 22 JUL 2013 
Purpose 
Hypothesis: #1The use of the BalanceBelt™ will provide differential information about body sway movements 
during specific clinical balance and gait tasks in patients with CSD that is not currently available through 
routine measures. 
Hypothesis: #2 The use of the BalanceBelt™ will provide for a more rapid rate of reduction in patient 
symptoms compared to the historical data from the traditional habituation therapy method. 
Aims, purpose, or objectives:  #1 Motion detectors contained in the BalanceBeltTM will be used to record 
information about the subtle changes in posture and gait that are thought to occur in patients with CSD with the 
tractors turned off.  The goal of this portion of the study will be to improve diagnostic strategies for CSD. 
Aims, purpose, or objectives:  #2 In this second portion of the study we will test the benefits of a 1-week 
intensive rehabilitation program using the BalanceBeltTM with tactors activated in 10 patients with CSD.  The 
goal of this study will be to develop a treatment that is quicker and more effective than current therapies. 
Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):  
Chronic subjective dizziness (CSD) is the second most common condition identified in patients referred to 
Mayo Clinic for persistent dizziness. We manage nearly 500 patients with CSD each year. CSD is a syndrome 
of persistent non-vertiginous dizziness and unsteadiness that may be worsened by patients’ own motion, 
exposure challenging visual stimuli such as busy shopping areas, or performance of precision visual tasks such 
as reading.  CSD develops in about 25% of patients following medical events that acutely disrupt balance. Once 
established, CSD may last for many years, even if the problems that triggered it resolves.  As a result, CSD 
causes considerable distress and functional impairment, even to the extent of work disability and disruption of 
family and social life (Staab, 2012).   
Over the last decade, the Mayo Clinic Integrated Neurotology team, and other investigators around the world 
have developed two treatment strategies for CSD.  One uses serotonergic medications such as sertraline (Zoloft) 
and venlafaxine (Effexor).  The other is a variation of vestibular and balance exercises known as vestibular 
habituation.  These therapies reduce symptoms for 60-80% of patients when administered by experts in the field 

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(Staab, 2012).  However, they have important shortcomings.  They are time-consuming, taking a minimum of 2-
3 months of diligent treatment to achieve best results.  They usually achieve a partial reduction in symptoms, 
which improves patients’ functioning, but falls short of a cure.  They can make patients worse, rather than 
better, when used by clinicians who are unfamiliar with them. 
A new theory about altered postural control mechanisms in CSD suggests that it could be diagnosed more 
accurately and treated more quickly by using an external vestibular prosthesis to enhance sensory feedback 
during vestibular exercises. A suitable prosthesis is the BalanceBeltTM, which is currently in final beta testing by 
BalanceTek, the company that developed it.  This device has been shown to have efficacy in reducing sway 
behavior in patients that have bilateral vestibular hypofunction (Sienko et al, 2010). For those patients with 
deficient vestibular systems the belt provides information that is missing from the lack of vestibular system cues 
for detecting sway or leaning behavior, hence drawing attention to the information that is missing. The 
BalanceBeltTM is a comfortable, self-contained unit worn under the clothes around the waist.  It has sensitive 
motion detectors and small tactors that vibrate against the skin at four locations to provide information about 
posture and motion.  Patients with CSD do not have permanent vestibular deficits, but underutilize vestibular 
signals because they develop visual or somatosensory dependence.  We expect the BalanceBeltTM to reset this 
error by providing patients with reliable motion stimuli.   
We propose two preliminary studies using the BalanceBeltTM in patients with CSD.  In the first study, we will 
use the motion detectors contained in the BalanceBeltTM to record information about the subtle changes in 
posture and gait that are thought to occur in patients with CSD.  This goal of this study will be to improve 
diagnostic strategies for CSD.  We will compare postural movements recorded with BalanceBeltTM with tactors 
turned off during quiet stance, normal walking (Dynamic Gait Index), functional reach test, and the Sensory 
Organization Test in 10 patients with CSD and 10 age and gender matched normal individuals.  In the second 
study, we will test the benefits of a 1-week intensive rehabilitation program using the BalanceBeltTM with 
tactors activated in 10 patients with CSD.  The goal of this study will be to develop a treatment that is quicker 
and more effective than current therapies. 
References: 
Staab, J.P: Chronic subjective dizziness. Continuum Lifelong Learning Neurol 2012; 18(5):1118–1141. 
Sienko, K.H., Vichare, V.V., Balkwill, M.D., Wall, C: Assessment of vibrotactile feedback on postural 
stability during pseudorandom multidirectional platform motion. IEEE TRANSACTIONS ON BIOMEDICAL 
ENGINEERING, 2010; 57(4): 944-952. 
Subject Information – charts, records, images, or specimens are considered ‘subjects’ 
Target accrual: Proposed number of subjects to be included in your study at your site. “Subjects” may include 
Mayo Clinic charts, records, or specimens, and/or charts, records, or specimens received at Mayo Clinic from 
external sources for collaborating analysis by the investigator under this IRB application:    

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Subject population:  20 patients with diagnosis of Chronic Subjective Dizziness (CSD) and 10 normal 
volunteers. 
Inclusion Criteria:  
1. Subjects will be 25-70 years of age inclusive and pregnant women may participate. 
2. Patients will have CSD as their primary diagnosis for the cause of their balance and
dizziness complaints provided by the Behavioral Medicine Program for Dizziness, a division of the 
Department of Psychiatry & Psychology. 
3. Normal volunteers will have a negative history of otologic & neurologic disorders and
no history of dizziness and balance problems. 
4. Normal volunteers will have normal findings on a screening office examination for
peripheral and central vestibular system involvement (see methods for details of the examination) and 
screening for normal or symmetrical hearing loss of explainable origin. 
Exclusion Criteria:  
 1. Patients with positive indications from testing of peripheral and/or central vestibular 
system involvement that is felt to be influencing the symptoms reported beyond the CSD alone. 
2. Patients with mobility restriction that would prevent participating in the tests or the
intensive therapy trials. 
3. Subjects with hearing impairment that interferes with oral communication.
Will a Certificate of Confidentiality be obtained? If yes, provide an explanation. 
NO 
Study Design 
Methods: Describe, in detail, the research activities that will be conducted under this protocol:  
For Hypothesis and aim #1: Ten consecutive patients, ages 25-70 years, diagnosed with CSD after completion 
of their routine evaluation in the Dizziness and Balance disorders laboratory and their evaluation by the 
Behavioral Medicine program for dizziness, would then be recruited for participation in the study. If they agree 
to participate they will individually be placed through the following evaluations while wearing the 
BalanceBelt™ with the tractors turned off but the recording elements turned on. Each of these tests is a standard 
evaluation tool used in the Vestibular and Balance Laboratory on a routine basis: 
1. Dynamic Gait Index – evaluates gait under normal walking and under conditions of head turns, walking
around two objects on the floor, stepping over a shoe box, walking at different speeds, walking with a
stop and 180 degree turn, walking up and down 3 standard steps with hand rails. During the evaluation
the physical therapist or the audiologist guards the subjects at all times walking with the subject and the
subject wears the harness used for the test in #3 that has a hand grab to prevent falls.
2. Functional Reach Test – the subject stands in a stationary position and reaches out with a single arm as
far as they can without taking a step. Here again the physical therapist or the audiologist is guarding the
patient during the performance of the test, again with the subject in the harness used in #3 with the hand
grab to prevent falls.

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3. Sensory Organization Test – this is a 6 condition standard evaluation of balance control performed on a
dynamic platform that can record sway movement in the A/P dimension while the sensory inputs from
proprioception and vision are varied through the platform and visual surround movements. The subject
wears a full chest harness that is fastened to a roll bar above the subject to prevent any falls.
For each of the patients an age and gender matched normal (± 5 years) volunteer will go through the same 
evaluations. The time for testing will take 45 minutes. Normal subjects will be recruited through written 
advertisements from visitors and / or accompanying persons for patients to Mayo Clinic. Each of the normal 
subjects will go through an office vestibular examination that will consist of direct monitoring for nystagmus in 
all positions of gaze with and without visual fixation present. They will also undergo the head thrust test with 
visual fixation present and headshake test with visual fixation absent. Pursuit and saccade office examination 
will be performed with a hearing screening by pure tones only. If any abnormalities are revealed with the 
screening the normal volunteer will be advised as to formal testing that should be performed via their primary 
care physician also being notified. 
For Hypothesis and aim #2: Ten consecutive patients, ages 25-70 years, diagnosed with CSD who live within a 
30 minute drive time of the Rochester Mayo campus will be asked to participate in the habituation therapy 
activities typically used as treatment of CSD but with an intensive treatment program using the exercises at 
home for the week. The patients will be using the BalanceBelt™ with the tractors activated. The typical therapy 
evaluations pre-therapy will be taken in addition to Visual Analog Scales related to the intensity of symptoms 
provoked by visual motion, head movements and walking in visually complex environments. These same 
measures will be taken at the end of the week of intensive therapy at a return visit to check their exercise 
activities prior to continuing their progressive home treatment. The one week of intensive therapy will be 
performed prior to starting any recommended medications or medication changes for the CSD. The therapy will 
be conducted by one of the Physical Therapists certified in Vestibular and Balance therapy. 
Following the intensive therapy the patient will continue with the therapy activities and medication trials as is 
standard currently for the CSD patients. 
Resources: Describe the available resources to conduct the research (personnel, time, facilities, mentor 
commitment, etc.):  
All of the equipment and procedures described above are already in place and used routinely by the 
Audiologists and Physical therapists that work in the Dizziness and Balance Disorders Center on Gonda-12 in 
the department of Otolaryngology. The only acquisition is that of the BalanceBelt™ for which the department 
of Otolaryngology research committee has approved a request for $7800 from the small grants program to cover 
the cost of the belt ($6000) and the 30% indirect costs ($1800). 
Check all that apply. If none apply, leave blank: 
 The research involves contact or interaction with subjects, for example, surveys, 
questionnaires, observation, blood draw. 

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Blood Collection 
If this study involves prospective blood collection by finger, heel, ear stick or venipuncture, complete the 
following:  
  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: _____ml   
Frequency of blood draw (e.g. single draw, time(s) per week, per year, etc.) _______ 
  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: _____ml 
Frequency of blood draw (e.g. single draw, time(s) per week, per year, etc.)_______ 
Review of Chart, Images, Specimens 
Provide the date range for collection of data and/or specimens that will be included in your research dataset.  
(Example: 01/01/2000 to 12/31/2012)  
Date range: From _02/01_/2014  to 01/_31/2015 
Check all that apply: 

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  This study involves only data and/or specimens that will be collected after submission to the IRB. 

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Data Confidentiality, HIPAA Subject Identifiers 
Review the list of subject identifiers below and, if applicable, check the box next to each subject identifier being 
recorded at the time you are collecting/abstracting data/specimens for use in this study. 
Subject Identifiers:  Individually identifiable information, including demographic data, that identifies the 
individual or for which there is reasonable basis to believe it can be used to identify the individual.  NOTE: 
Identifiers apply to subjects enrolled in your study and to the subject’s relatives, household members, 
employers, etc. 
Internal refers to subject identifiers that will be included in the dataset maintained by the study team. 
External refers to subject identifiers that will be shared with persons outside of the immediate study team, for 
example, sent to an external collaborator or shared with a national registry.  
SUBJECT IDENTIFIERS 
Check all that apply 
INTERNAL 
IDENTIFIER 
EXTERNAL 
IDENTIFIER 
Name 
Social Security number 
Medical record/patient registration number, lab accession, specimen or 
radiologic image number 
x 
Study number, subject ID, or any other unique identifying number, 
characteristic or code that can be used to link the identity of the subject to the 
data 
x 
Dates: All elements of dates [month, day, and year] directly related to an 
individual. Their birth date, date of death, date of diagnosis, etc.   
Note: Recording a year only is not a unique identifier.  
x 
Medical device identifiers and serial numbers 
Biometric identifiers, including finger and voice prints, full face photographic 
images and any comparable images 
Web Universal Resource Locators (URLs), Internet Protocol (IP) address 
numbers, email address 
Street address, city, county, precinct, zip code, and their equivalent geocodes 
Phone or fax numbers 
Account, member, certificate or professional license numbers, health 
beneficiary numbers 
Vehicle identifiers and serial numbers, including license plate numbers 
If None of the above identifiers will be recorded or maintained in the 
dataset and/or sent outside of the study team, please check “None”. 

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Statistical Information 
Note: Power analyses and study endpoints are not needed for a pilot or feasibility studies. 
 No statistical information. If checked, please explain: 
Statistical Considerations 
Power Statement:  Power analyses not used as this is a pilot study. 
Data Analysis Plan:  
For Hypothesis and aim #1: The outcome parameters from the BalanceBelt™ that represent the total amount of 
sway and sway activity in the A/P and M/L directions will be compare between the CSD patients and the 
normal age matched volunteers via the Wilcoxon rank-sum test for mean comparisons. 
For Hypothesis and aim #2: The visual analog scale scores pre & post the week of intensive therapy will be 
compared for the 10 subjects using also the Wilcoxon test for mean comparisons. 
Endpoints 
As this is a pilot study no fixed endpoints will be used.   
Primary: 
Secondary: