Vestibular Rehabilitation and Otolith Dysfunction
Phase: NA
Conditions: Dizziness
Sponsor: VA Office of Research and Development

Official Title: “Vestibular Rehabilitation and Otolith Dysfunction” 
NCT Number: 02652442 
Document date: 9-28-2021 
Scientific Background: Vestibular Rehabilitation (VR) is the treatment of choice for patients experiencing dizziness, imbalance, and mobility impairments related 
to vestibular dysfunction.  VR typically includes gaze stability exercises, which were developed to facilitate vestibular compensation of the semicircular canal-
mediated vestibulo-ocular reflex (VOR).  A critical signal to induce adaptation is retinal slip during head movements; thus, adaptation exercises involve head 
rotation while focusing on a target.  Most studies examining the effectiveness of VR have used only tests of VOR function (caloric and rotational tests) that 
measure horizontal semicircular canal to determine vestibular loss.  Thus, little is known about interventions to facilitate vestibular compensation of the otolith 
organs.  
The concept of using centrifugation for otolith adaptation may be similar to using gaze stability exercises for VOR adaptation.  Recent studies have demonstrated 
adaptation following otolith organ stimulation using centrifugation (or linear acceleration), but there is no data regarding optimum stimulus parameters.  The 
purpose of this study is to determine optimal off-axis distance of the rotary chair, duration of off-axis rotation (OAR), and training schedule for otolith 
adaptation. 
Study Objectives: The goal for testing different training protocols in healthy controls is: 1) to determine optimal stimulus parameters (off-axis distance of the 
rotary chair, duration of off-axis rotation, and training schedule) that will be used to treat patients with otolith dysfunction and 2) to demonstrate otolith 
plasticity with a given set of stimulus parameters.   
Study design: Sequential assignment to stimulus parameters (off-axis distance, duration of off-axis rotation, training schedule) 
Study Protocol: For healthy controls, only unilateral centrifugation (UC) training (randomized for right or left ear off-axis) will be performed.  Direction (CW or 
CCW) of off-axis rotation (OAR) will be standardized so that subjects are facing forward in the direction of rotation.   
Primary outcome measure: Static subjective visual vertical (SVV) assesses spatial perception and is influenced by otolith function. Perception of vertical is 
measured in a darkened room with subject seated upright. The test assesses an individual’s ability to adjust a laser line to be parallel with true vertical in the 
absence of any other visual cues. The start position of line for SVV testing is randomized and participants are instructed to use the track ball to position the line 
in a vertical position.  Five trials are completed, and the software calculates the distance (in degrees) from vertical.  The average of the trials is calculated and 
used for data analysis.  
 
 

Experiment 1.  Determination of optimal distance of OAR (n = 5 subjects).  Each subject will complete training at chair position (A) followed by (B) with at least 2 
weeks in between each training session until static SVV returns to normal. 
Training 
schedule 
Chair position 
off-axis (cm) 
Chair 
acceleration/ 
deceleration 
(°/s2) 
Chair velocity 
(°/s2) 
Duration of UC 
Cycles per 
session 
Measures 
5 
consecutive 
sessions 
(M-F) 
(A) 3.5 
5 
300 
90 sec accelerate to/ maintain 
constant velocity on-axis 
rotation; 1 min OAR at constant 
velocity; 60 sec to decelerate 
5 
Static SVV (5 trials) at start/end of each 
session  
same 
(B) 7.0 
same 
same 
same 
same 
same 
 
Experiment 2.  Determination of duration of OAR (n = 5 subjects).  Each subject will complete training at optimal chair position (determined in Exp. 1) for 
duration (A) followed by (B) with at least 2 weeks between each training session.   
Training 
schedule 
Chair position 
off-axis (cm) 
Chair 
acceleration/ 
deceleration 
(°/s2) 
Chair velocity 
(°/s2) 
Duration of UC (sec) 
Cycles per 
session 
Measures 
5 
consecutive 
sessions 
(M-F) 
Optimal 
distance as 
determined in 
Exp. 1 
5 
300 
(A) 
90 sec accelerate to/ 
maintain constant velocity on-
axis rotation; 1 min OAR at 
constant velocity; 60 sec to 
decelerate 
5 
Static SVV (5 trials) at start/end of each 
session  
same 
same 
same 
same 
(B) 
90 sec accelerate to/ 
maintain constant velocity on-
axis rotation; 3 min OAR at 
constant velocity; 60 sec to 
decelerate 
same 
same 
 
Experiment 3.  Determination of optimal training schedule (n = 5 subjects).  Each subject will complete training at optimal chair position (determined in Exp. 1) 
for optimal duration (determined in Exp. 2) with intermittent schedule (B) at least 2 weeks after completion of Experiment 2.   
Training 
schedule 
Chair position 
off-axis (cm) 
Chair 
acceleration/ 
deceleration 
(°/s2) 
Chair velocity 
(°/s2) 
Duration of UC (sec) 
Cycles per 
session 
Measures 
(A) 
5 
consecutive 
sessions (M-F) 
Optimal 
distance as 
5 
300 
90 sec accelerate to/ 
maintain constant velocity 
on-axis rotation; optimal 
5 
Static SVV (5 trials) at start/end of each 
session 

determined in 
Exp. 1 
duration of  (determined in 
Exp. 2) OAR at constant 
velocity; 60 sec to 
decelerate 
(B) 
2x/week 
x 3 weeks until 5 
sessions 
completed 
same 
same 
same 
same 
same 
same 
 
Statistical Analysis Plan: All data will be summarized using descriptive statistics. To examine the extent to which centrifugation parameters (distance, duration, 
schedule) impact the primary outcome (Subjective Visual Vertical, SVV) for healthy controls, paired t-tests will be used to examine change in static SVV (pre- to 
post-centrifugation).  Alpha level is 0.05.  No adjustments will be made for multiple comparisons. 

w
EAST TENNESSEE STATE
UNIVERSITY
Office for the Protection of Human Research Subjects • Box 70565 • Johnson City, Tennessee 37614-1707
Phone: (423) 439-6053 Fax: (423) 439-6060
IRB APPROVAL - Continuing Expedited Review
October 10, 2016
Dr. Courtney Hall
Re: Vestibular Rehabilitation and Otolith Dysfunction
IRB#: 1215.2s
ORSPA#:
The following items were reviewed and approved by an expedited process:
• xform 107, narrative portion of NPS, currently approved ICDs: Control ICD 3.11.2016 stamped
approved 3.22.2016; ICD 11.17.2015 stamped 12.03.2015, abstract, VROD protocol
Mar.2016, dgi-fga data collection sheet, Locus of Control Scale survey, Disability Rating Scale
survey, mmse survey, Health questionnaire Otolith Rehab, Vestibular Activities and
Participation Measure survey, VAS scales, PASE, Geriatric Depression Scale, Geriatric
Anxiety Inventory, ABC scale survey, protocol history
On October 4/2016, a final approval was granted for a period not to exceed 12 months and will
expire on October 3, 2017. The expedited approval of the study will be reported to the convened
board on the next agenda.
The following enclosed stamped, approved ICD has been stamped with the approval and expiration
date and this document must be copied and provided to each participant prior to participant
enrollment:
• Informed Consent Document (Control ICD 3.11.2016 stamped approved 10.4.2016;
ICD 11.17.2015 stamped 10.4.2016)
Federal regulations require that the original copy of the participant's consent be maintained in the
principal investigator's files and that a copy is given to the subject at the time of consent.
The ETSUA/A IRB has reviewed the HIPAA Authorization and determined that it is consistent with the
informed consent document and protocol. Researchers are responsible for obtaining the valid,
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Accredited Since December 2005

written HIPAA authorization of each individual research participant and providing a copy of the signed
Authorization to each participant. VA researchers are required to maintain the signed HIPAA
Authorization in accordance with VHA's Record Control Schedule 10-1 (RCS 10-1).
This study was approved under expedited category: ^Research on individual or group
characteristics or behavior (including, but not limited to, research on perception, cognition, motivation,
identity, language, communication, cultural beliefs or practices, and social behavior) or research
employing survey, interview, oral history, focus group, program evaluation, human factors evaluation,
or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the
HHS regulations for the protection of human subjects. 45 CFR46.101(b)(2) and (b)(3). This listing
refers only to research that is not exempt.).
Unanticipated Problems Involving Risks to Subjects or Others must be reported to the IRB (and VA
R&D if applicable) within 5 working days.
Proposed changes in approved research cannot be initiated without IRB review and approval. The
only exception to this rule is that a change can be made prior to IRB approval when necessary to
eliminate apparent immediate hazards to the research subjects [21 CFR 56.108 (a)(4)]. In such a
case, the IRB must be promptly informed of the change following its implementation (within 5 working
days) on Form 109 (www.etsu.edu/irb). The IRB will review the change to determine that it is
consistent with ensuring the subject's continued welfare.
Sincerely,
^^
Dr. Jonfethan Moorman, M.D., VA Vice Chair
ETSU/VA IRB

w
EAST TENNESSEE STATE
UNIVERSITY
Office for the Protection of Human Research Subjects • Box 70565 • Johnson City, Tennessee 37614-1707
Phone: (423) 439-6053
IRB APPROVAL - Continuing Expedited Review
August 23, 2017
Dr. Courtney Hall
Re: Vestibular Rehabilitation and Otolith Dysfunction
IRB#: 1215.2s
ORSPA#:
The following items were reviewed and approved by an expedited process:
• xform 107, narrative portion of NPS, currently approved ICDs: Dizzy Participant ICD
version11.17.15 stamped 10.4.2016 and Healthy Control ICD version 3.11.16 stamped
10.4.2016, abstract, VROD protocol Mar.2016, abstract, protocol history
On August 23, 2017, a final approval was granted for a period not to exceed 12 months and will
expire on August 22, 2018. The expedited approval of the study will be reported to the convened
board on the next agenda.
The following enclosed stamped, approved ICD has been stamped with the approval and expiration
date and this document must be copied and provided to each participant prior to participant
enrollment:
• Informed Consent Documents:
Dizzy Participant ICD version 11.17.15 stamped 8.23.17 with H I PAA Authorization
Healthy Control ICD version 3.11.16 stamped 8.23.17 with H I PAA Authorization
Federal regulations require that the original copy of the participant's consent be maintained in the
principal investigator's files and that a copy is given to the subject at the time of consent.
The IRB Vice Chair has determined the patient's medical record must be flagged.
The ETSUA/A IRB has reviewed the H I PAA Authorization and determined that it is consistent with the
informed consent document and protocol. Researchers are responsible for obtaining the valid,
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Accredited Since December 2005

written HIPAA authorization of each individual research participant and providing a copy of the signed
Authorization to each participant. VA researchers are required to maintain the signed HIPAA
Authorization in accordance with VHA's Record Control Schedule 10-1 (RCS 10-1).
This study was approved under expedited category: (7) Research on individual or group
characteristics or behavior (including, but not limited to, research on perception, cognition, motivation,
identity, language, communication, cultural beliefs or practices, and social behavior) or research
employing survey, interview, oral history, focus group, program evaluation, human factors evaluation,
or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the
HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing
refers only to research that is not exempt.).
Unanticipated Problems Involving Risks to Subjects or Others must be reported to the IRB (and VA
R&D if applicable) within 5 working days.
Proposed changes in approved research cannot be initiated without IRB review and approval. The
only exception to this rule is that a change can be made prior to IRB approval when necessary to
eliminate apparent immediate hazards to the research subjects [21 CFR 56.108 (a)(4)]. In such a
case, the IRB must be promptly informed of the change following its implementation (within 5 working
days) on Form 109 (www.etsu.edu/irb). The IRB will review the change to determine that it is
consistent with ensuring the subject's continued welfare.
Sincerely,
^?h-5>
Dr. Jonathan Moorman, M.D., VA Vice Chair
ETSUA/A IRB

^
EAST TENNESSEE STATE
UNIVERSITY
Office for the Protection of Human Research Subjects • Box 70565 • Johnson City, Tennessee 37614-1707
Phone: (423) 439-6053
IRB APPROVAL - Continuing Expedited Review
July 20, 2018
Courtney Hall, PhD
Re: Vestibular Rehabilitation and Otolith Dysfunction
IRB#: 1215.2s
ORSPA#:
The following items were reviewed and approved by an expedited process:
• xform 107, narrative portion of NPS, currently approved ICDs: Dizzy Participant ICD version
11.17.15 stamped 8.23.17 with HIPAA Authorization and Healthy Control ICDversion3.11.16
stamped 8.23.17 with H I PAA Authorization, abstract, VROD protocol Mar.2016, abstract,
protocol history
On July 16, 2018, a final approval was granted for a period not to exceed 12 months and will expire
on July 15, 2019. The expedited approval of the study will be reported to the convened board on the
next agenda.
The following enclosed stamped, approved ICD has been stamped with the approval and expiration
date and this document must be copied and provided to each participant prior to participant
enrollment:
• Informed Consent Documents:
Dizzy Participant ICD version 11.17.15 stamped 7.16.2018 with H I PAA Authorization
Healthy Control ICD version 3.11.16 stamped 7.16.2018 with H I PAA Authorization
Federal regulations require that the original copy of the participant's consent be maintained in the
principal investigator's files and that a copy is given to the subject at the time of consent.
The ETSUA/A IRB has reviewed the HIPAA Authorization and determined that it is consistent with the
informed consent document and protocol. Researchers are responsible for obtaining the valid,
written HIPAA authorization of each individual research participant and providing a copy of the signed
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Accredited Since December 2005

Authorization to each participant. VA researchers are required to maintain the signed HIPAA
Authorization in accordance with VHA's Record Control Schedule 10-1 (RCS 10-1).
This study was approved under expedited category: (7) Research on individual or group
characteristics or behavior (including, but not limited to, research on perception, cognition, motivation,
identity, language, communication, cultural beliefs or practices, and social behavior) or research
employing survey, interview, oral history, focus group, program evaluation, human factors evaluation,
or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the
HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing
refers only to research that is not exempt.).
Unanticipated Problems Involving Risks to Subjects or Others must be reported to the IRB (and VA
R&D if applicable) within 5 working days.
Proposed changes in approved research cannot be initiated without IRB review and approval. The
only exception to this rule is that a change can be made prior to IRB approval when necessary to
eliminate apparent immediate hazards to the research subjects [21 CFR 56.108 (a)(4)]. In such a
case, the IRB must be promptly informed of the change following its implementation (within 5 working
days) on Form 109 (www.etsu.edu/irb). The IRB will review the change to determine that it is
consistent with ensuring the subject's continued welfare.
Sincerely,
^1^
Dr: Jqfnathan Moorman, M.D., VA Vice Chair
ETSUA/A IRB

EAST TENNH5SHE STATH
TJNIVERSITY
Office for the Protection of Human Research Subjects o Box 70565 o Johnson City, Tenness ee376t4-1707
Phone: (423) 439-6053
IRB APPROVAL - Gontinuing Expedited Review
May 22,2019
Courtney Hall, PhD
Re:
IRB#:
ORSPA#:
Vestibular Rehabilitation and Otolith Dysfunction
1215.2s
The following items were reviewed and approved by an expedited process:
. xform 107, narrative portion of NPS, currently approved lCDs: Dizzy Participant ICD version
11.17 .15 stamped 7 .16.2018 with HIPAA Authorization ; Healthy Control ICD version 3.11.16
stamped 7.16.2018 with HIPAA Authorization, abstract, VROD protocol Mar.2016, protocol
history
On May 22,2019, a final approval was granted for a period not to exceed '12 months and will expire
on May 21,2020. The expedited approval of the study will be reported to the convened board on the
next agenda.
The following enclosed stamped, approved ICD has been stamped with the approval and expiration
date and this document must be copied and provided to each participant prior to participant
enrollment:
lnformed Consent Documents:
. Dizzy Participant ICD version 11.17 .15 stamped 5.22.2019 with HIPAA Authorization ;
o Healthy Control ICD version 3.11.16 stamped 5.22.2019 with HIPAA Authorization
Federal regulations require that the original copy of the participant's consent be maintained in the
principal investigator's files and that a copy is given to the subject at the time of consent.
The ETSUruA IRB has reviewed the HIPAA Authorization and determined that it is consistent with the
informed consent document and protocol. Researchers are responsible for obtaining the valid,
written HIPAA authorization of each individual research participant and providing a copy of the signed
Accredited Since December 2005

Authorization to each participant. VA researchers are required to maintain the signed HIPAA
Authorization in accordance with VHA's Record Control Schedule 10-1 (RCS 10-1).
This study was approved under expedited category: (7) Research on individual or group
characteristics or behavior (including, but not limited to, research on perception, cognition, motivation,
identity, language, communication, cultural beliefs or practices, and social behavior) or research
employing survey, interview, oral history, focus group, program evaluation, human factors evaluation,
or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the
HHS regulations for the protection of human subjects. 45 CFR 46.101(bX2) and (b)(3). This listing
refers only to research that is not exempt.).
Unanticipated Problems Involving Risks to Subjects or Others must be reported to the IRB (and VA
R&D if applicable) within 5 working days.
Proposed changes in approved research cannot be initiated without IRB review and approval. The
only exception to this rule is that a change can be made prior to IRB approval when necessary to
eliminate apparent immediate hazards to the research subjects [21 CFR 56.108 (aX4)] ln such a
case, the IRB must be promptly informed of the change following its implementation (within 5 working
days) on Form 109 (www.etsu.edu/irb). The IRB will review the change to determine that it is
consistent with ensuring the subject's continued welfare.
Sincerely,
*lrlO
Dr. Jonathan Moorman, M.D., VA Vice Chair
ETSUruA IRB

EAST TENNHSSEH S]AIE
IINIVF]RSITY
Office for the Protection of Human Research Subjects r Box 70565 r Johnson City, Tennessee3T614-1707
Phone: (423) 439-6053
IRB APPROVAL - Continuing Expedited Review
April 2, 2020
Courtney Hall, PhD
Re:
IRB#:
ORSPA#:
Vestibular Rehabilitation and Otolith Dysfunction
1215.2s
The following items were reviewed and approved by an expedited process:
. xform 107, narrative portion of NPS, currently approved Dizzy Participant ICD version 11.17.15
stamped 5.22.2019 with HIPAA Authorization ; Healthy Control ICD version 3,11.16 stamped
5.22.2019 with HIPAA Authorization, abstract, VROD protocol Mar.2016, VROD Recruitment
letter v.2.1 .19 stamped approved 5.22.2019, protocol history
On April 1 ,2020, a final approval was granted for a period not to exceed 12 months and will expire on
March 31,2021. The expedited approval of the study will be reported to the convened board on the
next agenda.
The following enclosed stamped, approved ICD has been stamped with the approval and expiration
date and this document must be copied and provided to each participant prior to participant
enrollment:
lnformed Consent Documents: (Dizzy Participant ICD version 11 .17 .15 stamped 4,1.2020 with
HlPAAAuthorization ; Healthy Control ICD version 3.11.16 stamped 4.1.2020 with HIPM
Authorization)
Federal regulations require that the original copy of the participant's consent be maintained in the
principal investigator's files and that a copy is given to the subject at the time of consent.
The ETSUA/A IRB has reviewed the HIPAA Authorization and determined that it is consistent with the
informed consent document and protocol. Researchers are responsible for obtaining the valid,
written HIPAA authorization of each individual research participant and providing a copy of the signed
o
.1r/L
IhII 
,'":,
,/ *ii'
'! .'\'\l l\:l'l' i'
r..lrruti.lt 
I
.,it
lccredited Since Deccnber 2005

Authorization to each participant, VA researchers are required to maintain the signed HIPM
Authorization in accordance with VHA's Record Control Schedule 10-1 (RCS 10-1).
This study was approved under expedited category: (7) Research on individual or group
characteristics or behavior (including, but not limited to, research on perception, cognition, motivation,
identity, language, communication, cultural beliefs or practices, and social behavior) or research
employing survey, interview, oral history, focus group, program evaluation, human factors evaluation,
or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the
HHS regulations for the protection of human subjects. 45 CFR 46.101(bX2) and (b)(3). This listing
refers only to research that is not exempt.),
Unanticipated Problems lnvolving Risks to Subjects or Others must be reported to the IRB (and VA
R&D if applicable) within 5 working days,
Proposed changes in approved research cannot be initiated without IRB review and approval. The
only exception to this rule is that a change can be made prior to IRB approval when necessary to
eliminate apparent immediate hazards to the research subjects [21 CFR 56.108 (aX4)]. ln such a
case, the IRB must be promptly informed of the change following its implementation (within 5 working
days) on Form 109 (www.etsu.edu/irb). The IRB will review the change to determine that it is
consistent with ensuring the subject's continued welfare.
Sincerely,
tnlr?6D
Di
nathan Moorman, M.D., VA Vice Chair
ETSUA/A IRB

 
 
 
 
Office for the Protection of Human Research Subjects • Box 70565 • Johnson City, Tennessee 37614-1707 
Phone: (423) 439-6053  
 
 
 
Accredited Since December 2005 
Continuing Review IRB Approval 
May 12, 2021 
  
Courtney Hall, PhD 
 
 
Re: 
 
Vestibular Rehabilitation and Otolith Dysfunction 
IRB#:  
1215.2s 
Sponsor: 
VA Funding 
   
On May 12, 2021, IRB approval was granted for a period not to exceed 12 months and will expire on 
May 11, 2022.  The expedited approval of the study will be reported to the convened board on the 
next agenda.  
 
This study was approved under expedited category: 
Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or 
sedation) routinely employed in clinical practice- excluding procedures involving x-rays or 
microwaves. Where medical devices are employed- they must be cleared/approved for marketing. 
(Studies intended to evaluate the safety and effectiveness of the medical device are not generally 
eligible for expedited review- including studies of cleared medical devices for new indications.) 
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and 
do not involve input of significant amounts of energy into the subject or an invasion of the subject’s 
privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) 
electrocardiography- electroencephalography- thermography- detection of natural occurring 
radioactivity- electroretinography- ultrasound- diagnostic infrared imaging- doppler blood flow- and 
echocardiography; (e) moderate exercise- muscular strength testing- body composition assessment- 
and flexibility testing where appropriate given the age- weight- and health of the individual. 
Category 7: Research on individual or group characteristics or behavior including - but not limited to- 
research on perception- cognition- motivation- identity- language- communication- cultural 
beliefs/practices- and social behavior- or research employing survey- interview- oral history- focus 
group- program evaluation- human factors evaluation- or quality assurance methodologies. NOTE: 
some of the research in this category may be exempt [45CFR46.101(b)(2) and (b)(3). This listing 
refers only to research that is not exempt. 
. 
 
The following items were reviewed and approved by an expedited process: 
• Continuing Review, narrative portion of NPS, abstract, VROD protocol March 2016, protocol 
history 
 

 
 
Note:  This study is closed to accrual; therefore, there are no stamped, approved informed consent 
documents for the current approval period. If this study is re-opened to accrual, revised informed 
consent documents will have to be submitted and approved by the IRB before enrollment of 
participants can resume 
 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSOs) must be reported to the 
IRB and VA R&D within 5 working days. 
  
Proposed changes in approved research cannot be initiated without IRB review and approval. The 
only exception is that a change can be made prior to IRB approval when necessary to eliminate 
apparent immediate hazards to the research subjects [45 CFR 46.108(3)(iii), 21 CFR 56.108 (a)(4)].  
In such a case, the IRB must be promptly informed of the change following its implementation (within 
5 working days) on xForm 109. The IRB will review the change to determine that it is consistent with 
ensuring the subjects’ continued welfare. 
 
Sincerely, 
 
 
 
Jon Moorman, M.D., Ph.D. 
VA Vice Chair, ETSU/VA IRB