Effectiveness of Sensorimotor Multi-axis Automated Rotational Therapy (SMART) for Post-Concussion Syndrome Rehabilitation
Phase: NA
Conditions: Post Concussion Syndrome
Sponsor: Neuroscience Group

PROTOCOL TITLE: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) for Post-
Concussion Syndrome  
 
 
 
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PROTOCOL TITLE: 
Effectiveness of Sensorimotor Multi-axis Automated Rotational Therapy 
(SMART) for Post- Concussion Syndrome Rehabilitation 
 
Date of Document Upload to ClinicalTrials.gov: 3/31/2026 
 
Date of Document Approval by IRB: 3/4/2026 
 
Primary Investigator: 
Nichole Siebert, MS, LAT, ATC 
GyroStim provider, records and data collection, study oversight 
Neuroscience Group 
920-725-9373 x3812 
Nichole.siebert@neurosciencegroup.com 
 
 
Sub-Investigators: 
Benjamin Siebert, MD, FAAPMR 
Patient provider, informed consent for study, and medical oversight 
Neuroscience Group 
920-725-9373 x5801 
Benjamin.siebert@neurosciencegroup.com 
 
Taylor Weuve, MBA, LAT, ATC 
GyroStim provider, records and data collection 
Neuroscience Group 
920-725-9373 x5602 
Taylor.weuve@neurosciencegroup.com 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL TITLE: 
Effectiveness of Sensorimotor Multi-axis Automated Rotational Therapy 
(SMART) for Post- Concussion Syndrome Rehabilitation 
 
 
Primary Investigator: 
Nichole Siebert, MS, LAT, ATC 
GyroStim provider, records and data collection, study oversight 
Neuroscience Group 
920-725-9373 x3812 
Nichole.siebert@neurosciencegroup.com 
 
 
Sub-Investigators: 
Benjamin Siebert, MD, FAAPMR 
Patient provider, informed consent for study, and medical oversight 
Neuroscience Group 
920-725-9373 x5801 
Benjamin.siebert@neurosciencegroup.com 
 
Taylor Weuve, MBA, LAT, ATC 
GyroStim provider, records and data collection 
Neuroscience Group 
920-725-9373 x5602 
Taylor.weuve@neurosciencegroup.com 
 
Research Assistant: 
Gemma Hodgkiss 
Medical Student, Medical College of Wisconsin 
Data collection and entry 
920-221-6621 
ghodgkiss@mcw.edu 
 
 
 
Consultants and study roles: 
Christine McGee, DNP, APNP, NP-BC 
Patient provider and informed consent for study 
Neuroscience Group 
920-725-9373 x5806 
Christine.mcgee@nurosciencegroup.com 

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Steffany Di Biase, APNP, FNP-C 
Patient provider and informed consent for study 
Neuroscience Group 
920-725-9373 x5806 
steffany.dibiase@neurosciencegroup.com 
 
Kevin Maher 
GyroStim inventor, manufacturer and study design consultant 
UltraThera Technologies 
719-685-7883, ext. 102 
kmaher@ultrathera.com 
 
Courtney Hall, Ph.D. 
Study design consultant, data analysis 
Professor Emeritus 
Eastern Tennessee State University 
423-926-1171, ext. 7518 
hallcd1@etsu.edu 
 
Jill Diedrich, MSHA, CMA 
Study design consultant 
Neuroscience Group 
920-725-9373, x8003 
Jill.diedrich@neurosciencegroup.com 
 
Nicole Shafran, SLP 
Study design consultant 
608-547-7362  
nicole.shafran@thedacare.org 
 
Standard Care Providers: These providers will be caring for and treating 
subjects in their respective fields. The standard testing they do will provide data 
for this study. These providers also helped input on the study design, with 
respect to their standard of care guidelines and practices. See sections 13, 14 
and 15 for details on therapies and testing.  
 
Katie Walters, DPT 
Physical Therapist  
Neuroscience Group 
920-725-9373 x3811 
Katie.walters@neurosciencegroup.com 
 

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Maria Joseph, DPT 
Physical Therapist  
Neuroscience Group 
920-725-9373 x3805 
Maria.joseph@neurosciencegroup.com 
 
Jenna Kadlec, PT 
Physical Therapist  
Neuroscience Group 
920-725-9373 x3802 
Jenna.kadlec@neurosciencegroup.com 
 
Lisa Truttschel, DPT 
Physical Therapist  
Neuroscience Group 
920-725-9373 x3804 
Lisa.truttschel@neurosciencegroup.com 
 
Rachel Haugley, DPT 
Physical Therapist  
Neuroscience Group 
920-725-9373 x3814 
Rachel.haugly@neuosciencegroup.com 
 
Caitlin Ryan, SLP 
Speech Therapist  
Neuroscience Group 
920-725-9373 x3809 
Caitlin.ryan@neurosciencegroup.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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VERSION NUMBER/DATE: 
Version 1 DATE. 
 
REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
2/11/26 
Frequency of GyroStim visits; new 
assistant; additional dx for inclusion 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NOTE: Leave this section blank for the initial submission. The revision history should be 
documented for modifications to approved studies. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
 
1. Study Summary……………………………………………………………….....6 
2. Background……………………………………………………………………….7 
3. Study Objectives and Endpoints……………………………………………...15 
4. Number of Participants………………………………………………………...16 
5. Inclusion and Exclusion Criteria……………………………………………....17 
6. Special Populations…………………………………………………………….18 
7. Recruitment Methods for Prospective Study.………………………………..18 
8. Consent/Assent Process……………………………………………………....19 
9. Process to Document Consent in Writing…………………………………....20 
10. Setting….…………………………………………………………………….....20 
11. Study Intervention………………..…………………………………………….20 
12. Prospective Study Timelines...………………………………………………..22 
13. Prospective Procedures Involved..…………………………………………...23 
14. Prospective Outcome Measures..……………………………………………24 
15. Prospective Intervention..……………………………………………………..25 
16. Schedule of Prospective Study Procedures………………..……………….27 
17. Comparison of Usual Care and Study Procedures………………………...30 
18. Withdrawal of Participants…………………………………………………….30 
19. Data Management & Confidentiality...……………………………………….30 
20. Provisions to Protect the Privacy Interests of Participants………………...32 
21. Sharing of Results……………………………………………………………...33 
22. Data & Specimen Banking…………………………………………………….33 
23. Study Analysis………………………………………………………………….34 
24. Potential Benefits to Participants……………………………………………..36 
25. Risks to Participants……………………………………………………..…….37 
26. Provisions to Monitor the Data to Ensure the Safety of Participants……..37 
27. Economic Burden to Participants………………………………………….….38 
28. Resources Available…………………………………………………………...39 
29. Multi-site Research…………………………………………………………….40 
30. Retrospective Study …………………………………………………………..40 
31. Statement on ethical considerations…………………………………………41  
32. References………………………………………………………………….….42 
33. Appendices……………………………………………………………………..45 

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1. 
Study Summary 
 
Study Title 
Effectiveness of Sensorimotor Multi-axis Automated Rotational Therapy 
(SMART) for Post-Concussion Syndrome 
Brief Summary 
This study evaluates the effectiveness of SMART on the reduction of 
symptoms for patients with post-concussion syndrome. We hypothesize 
SMART is effective for reducing persistent symptoms of mild traumatic brain 
injury (mTBI).  
Number of study sites 
1 
Primary Study Design 
Prospective Cohort Study  
Secondary Study Design 
Retrospective Data Analysis 
Primary Objective 
To evaluate the effectiveness of SMART in the treatment of patients with 
persistent post-concussion syndrome.  
Secondary Objective(s) 
To evaluate the effectiveness of SMART to treat patients with chronic post-
concussion syndrome who have plateaued in their recovery with standard of 
care (SOC) strategies.  
Research Intervention(s)/ 
Investigational Agent(s)  
Study will evaluate the effectiveness of SMART treatment, 2-4 treatment 
sessions per week, 10 sessions total to be completed within 5 weeks. 
Drugs/devices used on study 
(including any IND/IDE #)  
GyroStim - FDA Number: K220231 
Study Population 
18 year and older adult patients with a history of mTBI and diagnosed with 
post-concussion syndrome 
Sample Size 
116 required, recruit 128 – Prospective; 40-60 retrospective 
Study Duration for individual 
participants 
6 weeks 
Study Specific 
Abbreviations/ Definitions  
Sensorimotor Multi-axis Automated Rotational Therapy (SMART), Traumatic Brain 
Injury (TBI), Mild Traumatic Brain Injury (mTBI), Physical Therapy (PT), Speech 
Therapy (ST), Cognitive Rehabilitation Therapy (CRT), Occupational Therapy (OT), 
Post Concussion Symptom Scale (PCSS), Dizziness Handicap Inventory (DHI), 
Neck Disability Index (NDI), Functional Gait Assessment (FGA) and Modified 
Clinical Test of Sensory Interaction in Balance (CTSIB-m), Headache Impact 
Severity Level (Hit-6), Repeatable Battery for the Assessment of 
Neuropsychological Status (RBANS), Post-concussion syndrome (PCS), standard 
of care (SOC), Personal Health Questionnaire-4 (PHQ-4), Centers for Disease 
Control (CDC), Attention-Deficit/ Hyperactivity Disorder (ADHD), Food and Drug 
Administration (FDA), magnetic resonance imaging (MRI), computed tomography 
(CT), Optokinetic Nystagmus (OKN), Department of Defense (DOD), Electrical 
Muscle Stimulation (EMS), loss of consciousness (LOC), Sport Concussion 
Assessment Tool 5 (SCAT 5), indication for use (IFU), vestibular rehabilitation 
therapy (VRT), Vestibular Ocular Motor Screening (VOMS), Neuroscience Group 
(NSG), American Association of Neurological Surgeons (AANS), scheduling, 
information technology (IT), human relations (HR), ICD-10 (International 
Classification of Diseases 10th Revision) 

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2.  Background  
Concussion is a significant problem in the United States, contributing to 75% of the 
estimated 1.5 million traumatic brain injuries that occur each year (Permenter et al., 
2022). However, the Centers for Disease Control (CDC) estimates that between 
outpatient cases and the many that go unreported, it is between 1.4 and 3.8 million 
concussions per year (Ferry & DeCastro, 2023). While the initial symptoms can be 
problematic and should be given appropriate consideration, concussions are generally 
self-limiting with a good prognosis. Around 90% of symptoms related to concussion are 
resolved within 10-14 days (Permenter et al., 2022). However, for some, symptoms can 
linger for weeks, months and even years (Suleiman et al., 2019). While definitions and 
criteria for these lingering symptoms vary in literature, a diagnosis of post-concussion 
syndrome (PCS) is given for those with symptoms lasting for greater than 4 -12 weeks 
post injury (Permenter et al., 2022, Suleiman et al., 2019, Patricios et al., 2023). 
Unfortunately, clearly defined, comprehensive, and evidence-based treatments and 
rehabilitation for those suffering from PCS is lacking.  
The term concussion is often used interchangeably with mild traumatic brain injury 
(mTBI). According to the American Association of Neurological Surgeons (AANS), 
concussion “is defined as a clinical syndrome characterized by immediate and transient 
alteration in brain function, including alteration of mental status or level of 
consciousness, that results from mechanical force or trauma (Agarwal et al., 2024).” The 
trauma causing a concussion may be a direct or indirect blow to the head, or may result 
from rapid acceleration, deceleration, or rotational movements of the head (Ferry & 
DeCastro, 2023, Agarwal et al., 2024). It is recognized that while traditional magnetic 
resonance imaging (MRI) and computed tomography (CT) imaging does not show noted 
structural changes for those with concussion, at the functional, metabolic and blood flow 

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levels, changes may be noted (Patricios et al., 2023). This is due to the neurometabolic 
cascade that occurs at the time of injury. This cascade causes many changes at the 
cellular and biochemical levels including ionic shifts and changes in neurotransmission, 
connectivity, and metabolism. These changes lead to neuronal dysfunction and can 
cause axonal injuries and changes in blood flow (Ferry & DeCastro, 2023, Patricios et 
al., 2023, Giza & Hovda, 2001).  
The American Congress of Rehabilitation Medicine (ACRM) lists 6 criteria for a 
concussion (Silverberg et al., 2023): 
1. A plausible mechanism of injury 
2. One or more clinical signs including loss of consciousness, altered mental status, 
amnesia, or other acute neurologic signs. 
3. 2 or more acute symptoms including subjective altered mental status, physical 
symptoms, cognitive symptoms, and/or emotional symptoms. 
4. Clinical examination and laboratory findings, including cognitive, balance or 
oculomotor impairment or blood biomarkers indicative of intracranial injury. 
5. While not required, abnormal neuroimaging is considered. 
6. Signs and symptoms cannot be better accounted for by confounding factors. 
The types and severity of symptoms of concussion can vary from individuals, but 
they may include memory and/or concentration deficits, emotional or behavioral 
changes, headaches, confusion, dizziness and imbalance, visual disturbances and 
sensitivity, tinnitus, nausea and/or vomiting, insomnia and fatigue (Permenter et al., 
2022, Agarwal et al., 2024).  While factors such as age, sex and preinjury status and 
health complications can impact recovery from concussion, the majority of adults have 
resolved symptoms within 7-10 days with proper post-injury management. The literature 
demonstrates variability in the percentage of adult athletes that do not recover in the 

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expected time frame (Ellis et al., 2016). Those with symptoms that persist past 3 months 
is estimated to be around 15%. However, due to reporting variability amongst healthcare 
providers, difficulty with accurately documenting impaired cognitive function of patients 
and limited diagnostic tools, it is believed to be higher than 15% (Permenter et al., 2022). 
PCS symptoms are those symptoms that remain unresolved from initial injury resulting in 
concussion, and they can be debilitating affecting an individual’s physical, emotional and 
social lives. Many symptoms such as headache, dizziness, depression, and fatigue 
overlap with many other health problems. Because of this, getting accurate patient 
history related to their head injury and previous medical history are extremely important. 
Studies show that women, a history of Attention-Deficit/ Hyperactivity Disorder (ADHD) 
or other mood disorders, and a history of previous concussion are more likely to have 
lingering symptoms. There is mixed evidence that severity of injury or symptoms are 
correlated with PCS (Permenter et al., 2022, Ellis et al., 2016).  
Those that suffer from PCS can have long lasting cognitive and autonomic 
nervous system dysfunction due to damage that can affect the sympathetic and 
parasympathetic nervous systems. This damage can manifest itself in symptoms such 
as depression, headaches, dizziness, confusion and concentration difficulties, and even 
orthostatic intolerance (Permenter et al., 2022). It is also well documented that the 
vestibular system is greatly impacted from damage, which can affect balance and cause 
vertigo, syncope, and other symptoms. While the vestibular system is often recognized, 
chronic visual dysfunction after a concussion is often overlooked or underappreciated by 
many health professionals. This exists despite the well-established connection between 
the vestibular and ocular systems (Suleiman et al., 2019). 
Treating the vast constellation of symptoms that exist for those with PCS is 
challenging, and little evidence-based, comprehensive research has been done to 

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address caring for these patients. The recent 6th Consensus Statement on Concussion 
in sport notes that rehabilitation for specific symptoms, combinations of rehabilitation, 
timing, and accounting for modifying factors such as sex and age are not well 
established. However, rather than do nothing for athletes with lingering symptoms they 
recommend vestibular and/or cervicovestibular rehabilitation to help facilitate recovery 
(Patricios et al., 2023). The Clinical Practice Guidelines for Physical Therapy Evaluation 
and Treatment After Concussion/Mild Traumatic Brain Injury discuss symptom-based 
interventions. These interventions include addressing possible movement related and 
motor function impairments, cervical and musculoskeletal impairments, vestibular and 
oculomotor impairments, as well as exertional and exercise intolerance (Quatman-Yates 
et al., 2020). One particular report focused “on the early identification and targeted 
treatment of the pathophysiological mechanisms governing persistent concussion 
symptoms… [and] also outlines the qualified roles and responsibilities of healthcare 
professionals that can help contribute to the multi-disciplinary managements of this 
unique patient population” (Ellis et al., 2016). This report classified PCS into 
subcategories of physiological, vestibulo-ocular, and cervico-genic PCS, and 
recommended interventions based on these groups. They also recommended 
neuropsychological testing and interventions for those with cognitive dysfunction and 
pharmacologic intervention for headaches (Ellis et al., 2016).  
Unfortunately, a 2021 systematic review of Nonpharmacologic Treatments of 
Persistent Post-concussion Symptoms in Adults, found very low evidence for treating 
PCS symptoms with commonly recommended interventions such as vestibular 
rehabilitation, graded physical exercise, manual therapy, psychological treatments, 
oculomotor vision treatment, or psychological intervention. They stressed the need for 
further research on interventions for those with PCS (Rytter et al., 2021). 

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2.1 Potential Solution 
Given the need for improved treatments for patients that suffer from PCS, this 
study will collect data from clinical use of Sensorimotor Multi-axis Automated Rotational 
Therapy (SMART) to present to the Food and Drug Administration (FDA) as evidence of 
efficacy for an improved therapeutic treatment for PCS. 
 SMART has been in use for fifteen years and is recognized as an effective 
intervention for therapeutic treatment of vestibular dysfunction resulting directly from 
mTBI. GyroStim is FDA cleared and has been designated by the FDA as a Breakthrough 
Medical Device for the treatment of vestibular dysfunction.  SMART is used to stimulate, 
challenge, and improve the functional performance of the human sensorimotor system. 
GyroStim is a medical device designed specifically to provide SMART, and it will be 
utilized in this study.  
In 2022-23, a retrospective data collection was done at Heyser Chiropractic 
Neurology @ the Brain Center in Tallahassee, Florida. This was completed by Bill 
Heyser, DC. The data compares the results of two separate groups that suffered from a 
concussion, one group was subject to standard of care (SOC) treatment and the other 
group was subject to all SOC treatment plus SMART intervention with GyroStim.  
Standard of care treatment included the following interventions: 
· Neurosensory Integrator for multi-modal therapy including balance and 
rhythmic stabilization, motor/ sensory coordination, neurological rehab, 
improving reaction time, visual therapy including saccades and Optokinetic 
Nystagmus (OKN), and cognitive challenge. 
· Visual therapy to improve convergence, saccadic, and pursuit activity to 
integrate with motor/sensory and cognitive activity.  Integrate visual, 

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auditory, sequential programming.  Gaze stabilizing exercises 
· Cognitive therapy to improve memory, visual and auditory processing, 
such as memory exercises, Stroop exercises, mixed number-word 
exercises, etc.  
· Motor/sensory challenges with hand/eye coordination and memory/ 
sequential processing  
· Exercise bike to increase heart rate and oxygenation with visual or 
cognitive challenge, such as saccadic exercises using Hart charts for 
scanning, reading, word finding, and near/far saccades 
· Acupuncture, including neuro-acupuncture (scalp acupuncture) per 
Department of Defense (DOD) protocols 
· Chiropractic Manipulative therapy to establish and maintain normal 
biomechanics, especially of the cervical spine 
· Nutritional supplementation for metabolic support 
· Hyperbaric to increase oxygen saturation 
· Pain management consult for nerve block to decrease headache 
symptoms 
· Electrical Muscle Stimulation (EMS) to increase afferentation to brainstem 
· Cold laser for photomodulation effects to various tissues and organs 
· Gait training and exercises 
The subjects in the study are concussion patients with loss of consciousness 
(LOC)<30mins. The chart compares data collected using Sport Concussion Assessment 
Tool 5 (SCAT 5) for the assessment of symptom recovery over time. Group 1 patients 
were treated with Standard of Care (SOC) only. Group 2 patients were treated exactly as 
patients in Group 1, except this group of patients was also treated with SMART.  

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The data shows patients in Group 2 who received SOC plus SMART 
experienced an average of approximately 6X greater improvement on their SCAT 5 
score than patients in Group 1 who were treated with SOC alone. Additionally, Group 2 
gains occurred with an average of 1/2 the number of treatment sessions than patients in 
Group 1.  
Since its first clinical use for concussion in 2010, GyroStim has helped thousands 
of patients achieve successful recoveries, offering real-world validation of its 
effectiveness for vestibular dysfunction and other complications of mild traumatic brain 
injury (mTBI). Despite the large number of successful patient outcomes reported, and 
from pilot studies such as the one presented above, there are no scientifically valid 
studies for demonstrating efficacy of SMART.  The purpose of this study is to generate 
and gather scientifically valid clinical data that formally documents and supports the 
claims of these outcomes, so mTBI/PCS may be specifically included in GyroStim’s 

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indication for use (IFU).  The current Indications for Use (IFU) include the general 
indication for treatment of balance disorders and vestibular dysfunction, which supports 
GyroStim’s clinical application across a broad spectrum of neurological conditions known 
to benefit from vestibular rehabilitation therapy (VRT). This scope inherently 
encompasses patients with mTBI/PCS-induced vestibular dysfunction. However, to 
reduce confusion in the marketplace and ensure clarity, UltraThera intends to amend the 
IFU to explicitly state: “...and treatment for mTBI/PCS.” 
GyroStim is a computer-controlled multi-axis rotational chair. During treatment, 
the patient is safely and comfortably secured in the chair with a 5-point torso harness, an 
interlocked lap belt, and an interlocked ankle restraint.  The rotational chair is 
surrounded by a safety perimeter and is accessible through an interlocked entrance 
door. The circular safety perimeter has a steel frame and is fitted with clear 
polycarbonate panels mounted around the structure. 
The GyroStim operator has complete control of all movements of the rotational 
chair via the user interface computer. The operator can select prewritten motion profiles 
from a library within the software. Profiles can be selected in a strategic sequence that 
gradually increases a patient’s movements in degrees of motion, rotational speed, and in 
short durations from 15-60 seconds, each time being called a “run.” A typical therapy 
session will be comprised of 3 to 10 runs and will last approximately 30-40 minutes. 
Treatment typically begins with motion profiles that generate low levels of therapeutic 
stimulation that have slow rotation rates and move in minimal degrees of motion. The 
operator, working closely with the patient, can incrementally increase the intensity of the 
profiles as needed throughout the course of therapy. 
GyroStim also has 4 laser-detecting targets that are positioned around the chair. 

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The patient will be asked to use a handheld laser pointer to aim at and hit the targets 
during each run. The laser targets will transmit each laser hit back to the GyroStim 
computer where the hits will be counted and expressed in a value of hits-per-minute. 
Each run is followed by a rest period, and the patient is monitored for changes in 
symptoms using the Vestibular Ocular Motor Screening (VOMS) test scale. The VOMS 
scale is used in combination with the hits-per-minute score. Together they allow 
clinicians to administer data-driven therapy sessions that are individualized, providing 
safe and effective therapy progression while protecting the patient from overstimulation.   
Chronic post-concussion symptoms manifest and may persist as vestibular and 
cognitive dysfunction. SMART provides a means to address these symptoms, thereby a 
means to potentially address and resolve persistent post-concussion syndrome, 
providing relief for millions of patients.   
2.2 This Study 
The purpose of this study is to collect both retrospective and prospective clinical 
data for a statistical analysis of the effectiveness of GyroStim/SMART as a 
therapeutic intervention for post-concussion syndrome, both in terms of how it 
effects the rate of recovery and the extent of recovery.  
 
 
3. 
Study Objectives and Endpoints 
3.1 The objective of this study is to collect clinical data, both retrospective and 
prospective to document and statistically analyze the effectiveness of SMART in 
the treatment of patients with post-concussion syndrome.  
3.2  We hypothesize that patients who include SMART therapy as part of their 
treatment regimen will improve faster than patients who do not include SMART 
treatment.  
3.3  We hypothesize that patients whose treatment approach includes SMART will 
improve to a greater extent in their primary outcome measures than patients 
whose treatment approach did not include SMART.  

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3.4  The primary study endpoints are Post Concussion Symptom Scale [(PCSS) see 
Appendix B] Headache Impact Severity [(HIT-6) see Appendix C], [(NDI) see 
Appendix D], Dizziness Handicap Inventory [(DHI)see Appendix E], Neck 
Disability Index Functional Gait Assessment [(FGA) see appendix F], Modified 
Clinical Test of Sensory Interaction in Balance [(CTSIB-m) see Appendix G], 
Repeatable Battery for the Assessment of Neuropsychological Status [(RBANS) 
see Appendix H], and the Rivermeade Post-Concussion Symptom 
Questionnaire (see Appendix I). These assessments will be performed before, 
midway, and after intervention. There are no secondary end points to be 
evaluated. 
3.5  Safety endpoints include improvements in symptoms related to those primary 
endpoint measures. This includes improvements in headache, dizziness, 
balance, nausea, and cognitive function. 
3.6 Stopping rules include serious adverse events, such as injury or significantly 
worsened symptoms in one or more participants that would require other 
medical or emergent intervention. The study may also be stopped should interim 
data analysis reveal overall worsening of subjects in the SMART group, as 
compared to the control group. Other possible stopping rules would include 
unforeseen and unlikely events such as significant equipment problems with the 
GyroStim machine or computer that cannot be easily fixed, or major facility or 
personnel issues that cannot be easily or quickly rectified. Other possible rules 
would include the inability to recruit an adequate number of patients to complete 
the study.  
 
4. 
Number of Participants 
4.1     The prospective portion of this study will include 128 participants treated at the 
same location. We anticipate screening approximately 200 potential participants 
to reach our enrollment goal. 
4.2     Analysis requires 116 participants with 54 in each group. 128 will be enrolled, 
allowing for 64 in each group. 
4.3     Participants who leave the study early will be replaced, if we fall below the 116 
participants needed.  
4.4     The retrospective portion of this study will include clinical data from all patients 
that began SMART for treatment of symptoms related to a PCS diagnosis from 
1/1/24 through 12/31/24, which is between 40-50 patients. 
 
 

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5. 
Inclusion and Exclusion Criteria  
5.1 Participants will be screened in person by a clinic physician or nurse 
practitioner. 
5.2 A history of closed head injury and a current diagnosis of mTBI with persistent 
symptoms (≥ 4 weeks) consistent with persistent post-concussion syndrome 
(PPCS) or post-concussion syndrome (PCS) is the primary criteria for inclusion 
into the study. Subjects must also have a diagnosis of imbalance, dizziness or 
other relevant vestibular dysfunction. A diagnosis of relevant cognitive deficits or 
difficulties is required to qualify for ST/CRT. Any cognitive deficits or difficulties 
must be related to mTBI/concussion and must not be to the extent that would 
negate a subject’s ability to consent themselves. Subjects must be at least 18 
years of age and able to communicate verbally and be competent to consent.  
5.2.1 Subjects may have received care for their concussion and related 
symptoms from other providers prior to seeking care at Neuroscience Group. 
Providing they meet the above criteria, they will not be excluded from 
participation, as long as they are not doing PT or ST/CRT concurrently or have 
previously done SMART elsewhere for the treatment of this head injury.  
5.3 
Exclusion criteria include those patients under 18 years of age, those not 
competent to consent, those with a concussion that occurred less than 4 
weeks prior to initial visit, weighing greater than 400lbs, greater than 7ft tall, 
those unable to communicate verbally, pregnant, less than 12 weeks post-
partum, active benign paroxysmal positional vertigo (BPPV), severe 
claustrophobia, uncontrolled hypertension, uncontrolled seizures, increased 
risk of depression or anxiety, as determined by a score of 3 or more on either 
subset of the Patient Health Questionnaire-4 [(PHQ-4) see Appendix J], 
ankylosing spondylitis, concern for postural cardiac issues, active cervical 
radiculopathy or active cauda equina symptoms, Chiari malformation Type II-
IV, detached retina, or severe limitations with cervical range of motion. Other 
exclusions include those with neurological disorders including multiple 
sclerosis and Parkinson’s, severe depression or anxiety, those with hearing 
impairments, and significant vision dysfunction, and recent upper extremity 
injury.  
5.3.1 As pregnancy is an exclusion, medical staff will have potential female 
subjects fill out a pregnancy questionnaire (see Appendix K) to 
determine if pregnancy is a possibility. If it is possible, the subject will 
be given a form (see Appendix L) and provided with a home 
pregnancy test and package instructions (or they may use their own), 
which will need to be filled out and returned at the beginning of their 
first therapy visit. The home pregnancy test will need to be done 

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within 3 days of their first visit. They will also be advised to continue 
with proper contraception or abstinence, and they will also be 
informed that should they become pregnant, they will need to notify a 
member of our medical staff at Neuroscience Group as soon as 
possible.  
5.4 
Exclusions with special consideration and approval from provider may include 
post-surgical patients (must be greater than 8-12 weeks post-op to participate 
and may request approval from surgeon). Patients that receive care prior to 
the 4 week date post-concussion, may potentially still participate, depending 
on the care received.  This will be up to the discretion of our physician or 
nurse practitioner, if they feel it has significantly altered their expected 
prognosis or recovery timeline that could affect the study results.  
5.5 
Prescription anticoagulant medication use such as warfarin, heparin, lovenox 
and others will exclude a patient from participation. Over the counter aspirin 
use will not exclude a patient. Vitals including blood pressure, SpO2 and heart 
rate are taken prior to participating in GyroStim to help screen for potential 
issues. As always, the well-being of our patients is primary concern, and if the 
physician or nurse practitioners feel participation in this study due to 
medications is an unnecessary risk, the patient will be excluded from 
consideration.  
5.6 
Retrospective participants are nearly identical in the above inclusion and 
exclusion criteria. However, they did not fill out a PHQ-4 for consideration, 
prior to SMART.  
6. 
Special Populations 
6.1 
This study will not enroll or use data from any special populations. 
 
7. 
Recruitment Methods for Prospective Study 
7.1 Participants will be new patients or current Neuroscience Group (NSG) 
patients who are newly diagnosed with PCS. Only those patients that do 
not have a PHQ-4 score of 3 or more on either the anxiety or depression 
subset will be recruited.  
7.2 Participants will be recruited from the patient population within two possible 
clinic sites. They will be screened from their initial appointment with either 
Benjamin Siebert, MD, Christine McGee, DNP, APNP, NP-BC, or Steffany 
Di Biase, APNP, FNP-C for a diagnosis of post-concussion syndrome. All 
patients will be treated according to their symptoms, findings, and medical 
and rehabilitation needs, and those that qualify for the study will be asked if 
they will volunteer for the research study. All necessary medical records will 

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be accessed through EPIC, by those involved in the care and management 
of these patients.  
7.3 Patients will be asked to consider participation during their initial evaluation 
for post-concussion complications. If they are unsure, they will have two 
business days to determine their participation. They will need to let our 
scheduler know their participation status at the time of their initial call.  
7.4 There will be no formal materials used for recruitment, as the proposed 
study is in line with our current options and plan of care for our concussion 
patients. No additional materials or forms will be provided to potential 
subjects, other than the informed consent and pregnancy questionnaire and 
possible test form for potential female subjects. Should a patient desire to 
see GyroStim and how it works prior to deciding to participate, that can be 
arranged. The providers will explain their treatment options, and if they are 
qualified candidates, they will be asked if they would be willing to participate 
in the research. If they are not willing, they will not be denied SOC 
treatment or have their treatment plan altered in any way. Treatment 
options would include physical therapy, speech therapy, and GyroStim. 
Other options may include medications for headache management and 
sleep, vision therapy, optometry referrals, counseling or behavioral health 
referrals, further treatment for pain management, and referrals to other 
specialties, such as neurology. 
7.5 There will be no compensation for participants in either Group. 
8. 
Consent/Assent Process 
8.1 
Informed consent for Prospective Study: 
● Informed consent will be obtained by our physician or one of the nurse 
practitioners (see 5.2).  
● The consent process will take place onsite at Neuroscience Group, in 
one of the private clinic exam rooms. 
● The consent process will be conducted face-to-face, in person. 
● If a patient is unsure about wanting to participate, their provider will 
still go through the consent form and answer all questions. Our 
scheduler will contact the patient within approximately 2 business 
days and inquire about their decision to participate in the study or not. 
If they choose to proceed with participating, they will be asked to bring 
the consent form to their first PT or ST/CRT visit and sign it in the 
presence of their provider. If they would like more time to decide on 
participating, they can arrange a follow-up phone call with our 
scheduler. 

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● All participants have the right to stop treatment or withdraw from the 
study at any time. At the start of each PT session, ST/CRT session 
and SMART treatment session, and during those sessions, 
participants are frequently asked about their consent to proceed. 
 
8.2 
Informed Consent for Retrospective Study 
• 
No informed consent will be utilized for the collection of retrospective 
data. 
 
9. 
Process to Document Consent in Writing 
9.1      All signed informed consents will be copied and given to the participants 
for their records. Signed copies will be kept in a folder to be retrieved by 
one of the investigators to then document and store in a locked cabinet.  
 
10. 
Setting 
10.1 
 All data collection and related patient care will be performed in-clinic at 
Neuroscience Group. Initial provider exams will be performed in 
traditional, private exam rooms. SMART sessions will be conducted in-
clinic, in a private room that is designed specifically for the GyroStim 
equipment. Speech therapy (ST) or Cognitive Rehabilitation Therapy or 
CRT) will be performed in-clinic in a private room that is appropriately set 
up for evaluations and therapy. Physical therapy will take place in clinic 
with some exams and manual therapy being performed in a private room, 
and some exercises being done in a common physical therapy gym. 
 
10.2 
This is a large, private medical clinic with 2 main locations in Appleton 
and Neenah, Wisconsin. We have 58 licensed providers and 140 
additional care team personnel and staff to assist with reception, phone 
calls, billing, scheduling, information technology (IT), human relations 
(HR), public relations, management, etc. The Appleton location has 
approximately 31,225 square feet, including 41 exam/treatment rooms. 
The physical therapy gym at the Appleton clinic is approximately 1,600 
square feet and is appropriately equipped. The Neenah location has 
approximately 38,920 square feet with 58 exam/treatment rooms. All 
exam/treatment rooms are appropriately equipped to care for our patient 
population. There is an appropriately equipped physical therapy gym that 
will be utilized at the Appleton location that is approximately 1,269 square 
feet. 
   
11. 
Study Intervention 
11.1 
The study intervention is a therapeutic treatment for persistent post-
concussion symptoms following mTBI. The therapy will be administered 

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with a therapeutic medical device called GyroStim. GyroStim is FDA 
cleared and has been designated by the FDA as a breakthrough medical 
device (FDA number K220231). The intervention therapy produced by 
GyroStim is sensorimotor multi-axis automated rotational therapy, or 
SMART, and is the primary intervention of this study. SMART is used to 
stimulate, challenge, and improve the functional performance of the 
human sensorimotor system. SMART is administered with a 
methodology that presents incremental challenge to regions of the 
sensorimotor system that may have become dysfunctional as a result of 
mTBI. GyroStim offers technological advantages that allow it to produce 
a wide range of precisely controlled and complex therapy intensities, or 
“dosage of intensity,” with greater precision, control, and intensity than 
can be produced with manual PT techniques. GyroStim software 
provides the GyroStim operator with real-time objective and subjective 
patient response data that is used by the operator to individualize and 
optimize each therapy session. The real-time data is also used by the 
clinician for monitoring and protecting the patient from overstimulation 
that can occur during therapeutic treatment of mTBI. GyroStim software 
has capabilities to manage basic patient data, as well as treatment/run 
data. GyroStim software allows the clinician to select and run specific, 
individual programs in a series of runs that present incrementally 
increasing intensity, duration, and cognitive challenge to help promote 
functional gains and achieve patient rehabilitation. The intervention 
device, GyroStim, consists of a circular safety perimeter that has a steel 
framework with a safety interlocked entry door. The entire perimeter is 
paneled with transparent polycarbonate sheets to allow the GyroStim 
operator to maintain constant visual observation of the patient during 
therapy. GyroStim is a multi-axis rotational device consisting of two 
rotational frames, with the first frame rotating in the yaw axis (clockwise 
and counterclockwise) and the second frame mounted on top of the first 
frame and rotates in the pitch axis (forward and backward). The 
rotational frames are attached to powerful and precise electrical motors 
that provide motion in their respective axis. Each frame can rotate about 
its axis through 360 degrees continuously, either one axis at a time, or 
both axes simultaneously, if desired. The patient chair is mounted within 
the pitch frame. It has clear polycarbonate safety shielding on both 
sides and overhead and is open at the front of the chair for patient 
access. The chair has an adjustable 5-point patient harness for securing 
the patient during rotation, the seatback height is adjustable, and the 
chair has an adjustable height footrest. There is an electronically 
interlocked safety belt for securing across the patient’s lap, as well as an 
electronically interlocked belt that goes across the patient’s ankles. Both 
yaw and pitch motors receive motion commands from the user interface 

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computer. The motors work collectively to rotate the chair specifically as 
directed by the prewritten therapeutic program that has been selected by 
the clinician. The GyroStim software has a library of prewritten programs 
that provide quick and easy access to all 30 levels of therapeutic 
intensity. There are 4 laser-detecting targets that are mounted on the 
safety perimeter, with approximately 90 degrees separation between 
each laser target. While rotating in the chair, the patient may be directed 
by the clinician to use a hand-held laser pointer in their right hand, left 
hand, or both hands to try and hit the targets. Each time the patient hits a 
target, the target will illuminate and beep. Additionally, the target will 
transmit a “hit” signal to the user interface computer for data processing 
and collection. Patient safety is continuously maintained via numerous 
hardware and software safety interlocks. Each interlock must be in a 
safe state, or the device will not operate, i.e., door must be shut, step 
must be down, all safety belts must be latched, door must be closed, etc. 
There are patient activated STOP buttons located at the end of each 
hand hold which allows the patient to terminate the therapy run at any 
time. The operator has access to a STOP RUN button on the user 
interface screen that will terminate the run and bring the patient back to 
the HOME position. There is a large emergency stop button that is 
position near the operator that when pushed removes all power from the 
automation motors in the event of an emergency. 
 
11.2 
Drug/Device Handling: The device being used, GyroStim, is a large, 
computer-controlled machine that cannot be moved to another room or 
location. It is also only run by two people within the clinic, with one 
person being the primary provider.  
 
12. 
Prospective Study Timelines 
12.1 
An individual participant’s average study time is 6 weeks. 
12.2 
It is anticipated to take approximately 18 months to complete the study of 
116 participants. 
12.3 
It is estimated to take approximately 18 months from IRB approval to 
complete the study. 
 

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13. 
Prospective Study Procedures Involved 
13.1 
Participants will self-select into Control Group, or GyroStim Group. All 
Groups will have the same experience during the intake process, and 
they will have the same training for at-home daily exercise routines. Each 
group will contain 64 participants for a total of 128 participants. Control 
Group participants will be treated with SOC involving one in-clinic 
targeted physical therapy (PT) session per week, for five weekly SOC 
sessions total to be completed within 5 weeks. They will also be treated 
with cognitive rehabilitation therapy/speech therapy (CRT/ST) with one 
session per week, for 5 weekly sessions, to also be completed within 5 
weeks. GyroStim Group participants will be treated the same as Control 
Group with SOC involving one in-clinic targeted physical therapy session 
and one cognitive rehabilitation therapy/speech therapy per week. In 
addition to their PT and ST/CRT each week, GyroStim Group participants 

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will also complete a total of 10 GyroStim sessions within a timeframe of 
no longer than 5 consecutive weeks. Preliminary data taken from a 
retrospective data analysis from patients at AVORA Health in North 
Carolina, collected by Kim Fox, DPT demonstrates faster rehabilitation 
times, with higher frequency visits utilizing GyroStim (write-up done by 
Keving Maher, Ultrathera Technologies and analysis done by Coutney 
Hall, PhD, Professor Emeritus at Easter Tennessee University; see 
Appendix M for write up). As such, it is recommended to have patients 
participate in GyroStim visits up to 4 times a week. However, given 
patient needs, the study is designed with treatment density per week 
flexibility, allowing patients to select to participate at treatment density 
rates of 4, 3, or 2 sessions per week. Outcome data from all participants 
in both groups will be included in the study outcome data. 
13.2 
Standard of care for all participants in both groups will include physical 
therapy and CRT/ST. Other treatments or therapies may also include 
vision therapy/rehabilitation, vitamin/supplement utilization, medications 
and interventional treatments for headache management and/or other 
pain, medication for treatment of sleep disruption, neuro-optometry with 
eyeglass prescription with or without prism glasses, neuropsychological 
testing, pain management, and/or behavioral counseling.  
13.3      Assessments will occur for all participants in both groups, Control Group 
and GyroStim Group, based on the following schedule: 
 
● Baseline Test – tests will occur at the beginning of the first visit with PT 
and with CRT/ST. If the participant is doing GyroStim, they will also 
begin their session within that week. 
● Follow-up – tests will occur at the beginning of the 6th PT and CRT 
session.  
 
 
14. 
Prospective Study Outcome Measures 
14.1    Assessments for all participants will include the following: 
PT Testing: 
▪ 
Post Concussion Symptom Scale (PCSS) (Appendix B) 
▪ 
Headache Impact Severity Level (HIT-6) (Appendix C) 
▪ 
Neck Disability Index (NDI) (Appendix D) 
▪ 
Dizziness Handicap Inventory (DHI) (Appendix E) Functional Gait 
Assessment (FGA) (Appendix F) 
▪ 
Modified Clinical Test of Sensory Interaction in Balance (CTSIB-
m) (Appendix G) 
 
 

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CRT/ST Testing: 
▪ 
Repeatable Battery for the Assessment of Neuropsychological 
Status (RBANS) 
▪ 
Rivermeade Post-concussion Symptom Questionnaire (Appendix 
I) 
 
15. 
Prospective Study Intervention 
15.1 Control Group: SOC  
▪ 
Customized Physical Therapy 
▪ 
Each participant will follow typical SOC physical therapy that will be 
individualized to provide targeted therapy strategies for treatment of 
their specific mTBI symptoms. 
▪ 
The treating clinician will create and provide a customized VRT 
home exercise program (HEP) per standard of care, consisting of 
gaze stabilization, habituation, balance and gait exercises, and 
endurance training (Hall et al., 2021). Gaze stabilization exercises 
(GSE) were developed based on the concepts of VOR adaptation 
and substitution and involve head movement while maintaining 
fixation on a target which may be stationary or moving. Gaze 
stabilization exercises based on the principles of substitution were 
developed with the goal of promoting compensatory strategies. 
For example, during eye-head movement between targets, a large 
eye movement to a target precedes the head turning towards the 
target, potentially facilitating preprogrammed eye movements. 
Habituation involves repeated exposure to the stimulus that 
causes dizziness and over time this systematic repetition of 
provocative movements leads to symptom reduction. Habituation 
exercises are chosen based on movements (of self or the visual 
environment) that provoke symptoms, and the patient performs 
several repetitions of body or visual motions that cause mild to 
moderate symptoms. Balance and gait exercises are chosen 
based on identified impairments and limitations and are performed 
under challenging sensory and dynamic conditions to optimize 
functioning of the sensory and motor systems underlying postural 
control. Balance exercises may include static standing balance 
with altered base of support, altered visual and somatosensory 
cues, dynamic weight shifting and reactive balance control 
training. Gait activities may include walking on uneven terrains, 
over/around obstacles, and walking with head turns, varied 
speeds, and with a cognitive or motor dual task. General 
conditioning, such as a customized graduated walking program for 
endurance, is frequently an element of VPT because individuals 

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with dizziness often limit physical activity to avoid symptom 
provocation. 
 
▪ 
Each participant will receive 6 SOC therapy sessions, with testing to 
be done at the beginning of the 1st and 6th visit. The sessions will be 
in-clinic with a physical therapist(s), occurring once per week, and all 
6 sessions must be completed within 6 weeks.  
▪ 
Each participant will be given training and instructions for performing 
at-home therapy exercises during the intervention period. 
▪ 
Each participant will be encouraged to maintain proper hydration and 
nutrition, optimize sleep, reduce stressors, and comply with other 
directed clinical therapies/treatments, if indicated, during the 6-week 
program. 
▪ 
Cognitive Rehabilitation Therapy/Speech Therapy 
▪ 
Each participant will also follow typical SOC CRT/ST that will be 
individualized to provide targeted therapy strategies for treatment of 
their specific cognitive symptoms related to mTBI/PCS. 
▪ 
Each patient will be evaluated at their initial CRT/ST appointment and 
undergo RBANS testing. They will be seen weekly for ongoing 
therapy. This may include education, energy management, memory, 
attention, reasoning, executive function, processing, and word 
retrieval tasks, as well as strategies to help aid in memory and 
attention at home, such as organizational and system suggestions to 
aid in maintaining schedules and functional tasks related to daily life. 
Patients are also assigned tasks to do at home which may include 
continued work on reading, puzzles, games, cards, etc.  
▪ 
Each participant will receive 6 SOC CRT sessions, with testing to be 
done at the beginning of the 1st and 6th visit. The sessions will be in-
clinic with a speech therapist, occurring once per week, and all 6 
sessions must be completed within 6 weeks. 
 
15.2 GyroStim Group: SOC combined with GyroStim / SMART Therapy 
▪ 
GyroStim therapy in addition to SOC targeted PT and CRT/ST 
▪ 
In addition to the intervention protocol described above for Control 
Group, participants in GyroStim Group will receive 10 SMART 
treatment sessions with GyroStim, with each session duration of 
less than 40 minutes. The in-clinic sessions will occur twice per 
week, will occur during the same week, but not on the same days 

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as their once per week visits each for PT and CRT/ST. All 10 
GyroStim sessions will be completed within 5 weeks. Each 
SMART session will follow the GyroStim Run-to-Run Progression 
Strategy, with clinical decision making by a licensed athletic 
trainer (LAT) to help determine progression.  
 
16. 
Schedule of Prospective Study Procedures 
16.1 
 
 
 
 
● GyroStim is the device that will be used to produce the SMART 
therapeutic intervention being investigated.  

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● PT evaluated FGA and mCTSIB scores, patient reported CGS, HIT-6, 
NDI and DHI scores (see Appendices), and ST evaluated RBANS and 
Rivermeade Post-Concussion Symptom Questionnaire scores.  
● Other noted interventions for patients may include other treatment, such 
as vision therapy, counseling, optometry, and headache management 
medications. However, unless significant trends appear within participant 
groups, there is no plan to investigate these further. 
● Epic medical records may be used to collect information about the 
participants. 
16.2 
While participants may continue medical care, no additional long-term 
data will be collected for the study.  
 
16.3 
GyroStim is an FDA cleared medical device for the treatment of balance 
disorders and vestibular dysfunction. As vestibular dysfunction is often a 
symptom of post-concussion syndrome, it is being investigated as a 
treatment for PCS. All participants in this study have been diagnosed with 
either a balance disorder or vestibular dysfunction. There exists a large 
body of anecdotal evidence and patient testimony that patients 
experience significant reduction, and in many cases complete recovery 
from persistent symptoms from mTBI. This study aims to collect clinical 
data to assess whether this intervention produces statistically significant 
findings in this patient population. 
 
16.4 
GyroStim is safe to use up to 4 times per week in this study. 
Based on cumulative clinical experience, published data, and device 
safeguards, use at a frequency of up to four times per week in the 
proposed study is supported as safe within established protocols. 
 
16.4.1  Long-Term Clinical Use 
GyroStim has been in clinical use since 2010, representing over 16 years 
of operational experience without reported serious adverse events 
attributable to treatment frequency. In clinical practice, treatment 
frequency has varied based on patient need, including higher-intensity 
schedules for traveling patients. 
 
When patients travel long distances, typical protocols may include one to 
two sessions per day over five consecutive days without incident, 
demonstrating tolerance at frequencies exceeding four times per week. 
 
16.4.2 Published Data 
The Fox study (see Appendix M) included seven participants treated 
between four and ten times per week, with no reported adverse events. 

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While the sample size is limited, it provides direct evidence of tolerability 
at frequencies above four sessions weekly. 
 
16.4.3 Standard of Care Context 
Conventional vestibular rehabilitation therapy (VRT) commonly involves 
habituation exercises performed up to three times daily. GyroStim 
provides vestibular stimulation within a controlled, clinician-supervised 
environment, aligning with accepted therapeutic paradigms for vestibular 
habituation and adaptation. 
 
16.4.4 Regulatory Status 
GyroStim is cleared by the U.S. Food and Drug Administration for 
providing vestibular stimulation for symptoms of vestibular dysfunction. 
The FDA clearance does not specify limitations regarding frequency, 
intensity, or duration of treatment. 
 
16.4.5 Built-In Safety Controls 
The treatment protocol incorporates multiple safeguards: 
• 
Symptom assessments between each run, comparing baseline and post-
run status 
• 
Data-driven decision-making (DDDM) is built into the software to prevent 
overstimulation 
• 
Patient-controlled stop buttons on both handholds 
• 
Controlled deceleration and automatic return to upright HOME position, if 
the patient presses the Stop button 
• 
These mechanisms provide continuous monitoring and immediate 
intervention capability during treatment. 
 
16.4.6 Conclusion 
Considering: 
• 
16+ years of clinical use without frequency-related incidents 
• 
Documented tolerability at frequencies exceeding four sessions 
per week 
• 
Alignment with conventional vestibular therapy dosing paradigms 
• 
FDA clearance without frequency restrictions 
• 
Structured procedural safeguards and patient control features 
 
Use of GyroStim at up to four times per week is supported as safe within 
the defined study protocol and standard operating procedures. 
 
 

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17. 
Comparison of Usual Care and Study Procedures 
17.1 
SOC for participants, with or without SMART, is available to all patients, 
without participating in the study. This may include all or none of the 
following: physical therapy, speech therapy, vision therapy, referrals for 
optometry, counseling, headache management medications, and other 
medically necessary referrals. All prescribed treatments are based on 
medical need and patient consent.  
17.2 
Testing procedures and therapy visits for participants in the study are the 
same as the testing procedures and therapy visits for patients who 
choose not to participate in the study. However, it is noted that 
participants in the study will be more stringently scheduled, as compared 
to non-participants, to improve statistical validity and reliability. 
17.3 
Great care was taken to design the study to fit the typical SOC for our 
patients. If it is in the best interest of the patient to alter their care in a 
manner that conflicts with the study design, the patient may be removed 
from the study and proceed with care as prescribed and recommended by 
their provider. 
 
18. Withdrawal of Participants 
18.1 
Anticipated reasons for patient withdrawal without their consent include 
excessive rescheduling that alters testing timelines, illness, or 
other/additional injuries. Other possibilities include patient intolerance to 
SMART, although it is anticipated most of these patients will elect to self-
terminate.  
18.2 
Orderly termination, as with any service, treatment, or therapy that is 
halted, will be discussed with the patient. It is this clinic’s primary focus to 
treat and work with our patients, regardless of research status. Their SOC 
will continue, in ways to best accommodate the patient.  
 
19.  Data Management and Confidentiality 
19.1 To prevent a loss of confidentiality, all paper study records will be stored 
in a locked cabinet in a locked room in room 1430 at the Neuroscience 
Group building at 445 W. Calumet Appleton, WI 54915. We will code 
study data with a study identifier (not participant’s name) and keep coded 
data separate from personal information such as name and contact 
information. Study data (using only the study identifier) will be maintained 
in an electronic computer file on a secure server at Neuroscience Group. 
Only approved study staff will have access to any of the data. The results 

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of this study may be published and/or presented at meetings without 
identifying individual subjects.  
19.2  All data and participant information will be secured in compliance with 
electronic medical records standards and will be treated according to all 
necessary HIPPA standards, as would any other medical data within the 
clinic. All providers undergo yearly HIPAA compliance training, as 
required by law for a medical practice. Any compiled data in spreadsheet 
form will/ be kept under secure electronic storage that is not connected to 
the internet. Any transmission of data will be through secure medical 
records software or secured email, which is used by the medical 
providers participating in this study. All de-identified study data will be 
kept for 3 years.  
Select all that apply: 
x 
Data will be coded, and the “key” linking identities to codes will be 
kept separately from the data. 
☐ Data will be coded, and the “key” linking identities to codes will be 
kept on paper only. The study data will be stored electronically 
and labeled only with codes. 
☐ Only those listed as key personnel will have access to the “key.” 
x 
Access to the “key” will be limited to the following persons (e.g., 
PI):  Nichole Siebert, MS, LAT, ATC, Taylor Weuve, MBA, LAT, 
ATC, Benjamin Siebert, MD 
☐ This study is funded by the National Institutes of Health and is 
covered by a Certificate of Confidentiality. 
☐ This study is NOT funded by the National Institutes of Health but 
because it will collect sensitive information, the research team will 
apply for a Certificate of Confidentiality to protect data from being 
requested without the subject’s consent as part of a legal 
proceeding. 
☐ Other: _______________________________________________ 
 
19.3 Describe how and where data and/or specimens will be stored and 
maintained. The following list is provided for convenience but is not an 
exhaustive list. Select all that apply: 
☐ Online Collaborative Research Environment (OnCore) 
Biospecimen Management 
☐ Research Electronic Data Capture (REDCap) Specify which 
instance you will be using (e.g., ICTR’s, Department of 
Medicine’s): ___________________________________ 
x Other software option that will be stored on departmental server. 
Specify:  electronic file on secure server. 

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x Locked filing cabinet or drawer inside a locked room. Specify the 
building: _Neuroscience Group 445 W. Calumet, Appleton, WI 
54915, GyroStim room #1430.___________________________ 
x Other (describe): see 16.2 description________________ 
x Data will not be stored or accessed on portable devices. 
☐ Portable devices will be used to access secure web-based data 
collection sites such as ICTR’s REDCap. No data will be stored 
locally on the device. 
☐ Data stored on portable devices will be coded with the key stored 
separately. No identifiers will be stored on portable devices. 
☐ Data stored on portable devices and therefore only encrypted 
devices will be used. 
 
19.4   Management of Identifiers: Explain whether there will be a unique code 
on the specimen/dataset that can be used to LINK to a participant’s 
identity, but will not, by itself, reveal who the participant is. If you will 
create and maintain a “key” linking identities to codes, explain where this 
key will be stored. Define when identifiers (such as names) or the “key” 
linking codes to identifiers will be destroyed, if known. Please modify the 
common options below as needed. 
☐ Identifiers will be destroyed after all data has been collected. 
☐ Identifiers will be destroyed at study closure. 
x 
Identifiers will be destroyed at study closure or at the time of 
publication. 
 
20.  Provisions to Protect the Privacy Interests of Participants 
20.1 
Where appropriate and possible, procedures will be performed in a 
private area where others cannot see the procedures being performed 
or overhear the conversation between subjects and researchers. The 
exception is the common physical therapy gym, but this is typical of PT 
gyms.  
 
20.2 
All members of the clinical study team are up to date on their 
institutional HIPAA training. 
 
20.3 
The study is not collecting information that could pose legal or 
reputational risks to participants. 
 
20.4 
Patients will have treatments and procedures explained thoroughly, 
prior to beginning the therapy. Patients are also encouraged to ask 
questions, and care is taken to assist patients in feeling comfortable. 

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Therapy is not initiated, carried out, or progressed without patient 
consent and acknowledgement.  
 
20.5 
All EMR data is accessed by authorized personnel only. Any data 
shared will be in coded, spreadsheet or document format, without 
patient names.  
 
 
21. 
 Sharing of Results  
21.1 
Depending on patients’ other care providers’ access to EMR, they may 
be able to see their care and treatments, but this would not differ from 
other normal medical care.  
 
21.2 
The results of the study will be shared with UltraThera Technologies for 
clinical evidence and in the FDA 510(k) application process for 
GyroStim. The de-identified data will likely be shared with insurance 
companies for consideration of treatment reimbursement, with peered 
reviewed journals for publication consideration, and with CMS for new 
CPT coding. UltraThera may present the de-identified clinical data to 
medical professionals, and anyone interested in considering SMART for 
treatment of PCS.  
 
21.3 
De-identified data will also be shared with Courtney Hall, PhD, Professor 
Emeritus at Eastern Tennessee State University for statistical analysis. 
 
21.4 
All de-identified data will be transmitted through secure, electronic 
means, such as EMR or secure e-mail.  
 
21.5 
As much as possible, any patient identifiers will be withheld/masked and 
only codes will be used. 
 
21.6 
The results of this study may be published and/or presented at meetings 
without identifying individual subjects. 
 
 
22. Data and Specimen Banking 
22.1 
While we do not currently have plans to conduct further research 
after the completion of this study, it is possible the deidentified data 
maybe retained for further studies to be conducted at Neuroscience 
Group or distributed to other entities for further research. 
 

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23. Prospective Study Analysis 
23.1 Statistical Hypotheses: State the formal and testable null and alternative 
hypotheses for primary and key secondary endpoints, specifying the type of 
comparison (e.g., superiority, equivalence or non-inferiority, dose response) 
and time period for which each endpoint will be analyzed. 
 
H1:   We hypothesize that the group with SMART as part of their treatment 
regimen will improve faster than patients who do not include SMART 
treatment.  
 
H0:   We hypothesize that the group with SMART as part of their treatment 
regimen will improve at the same rate as patients who do not include 
SMART treatment.  
 
H1:   We hypothesize that the group with SMART as part of their treatment 
regimen will improve to a greater extent in their primary outcome measures 
from baseline to discharge than patients whose treatment approach did not 
include GyroStim.  
 
H0:   We hypothesize that the group with SMART as part of their treatment 
regimen will improve to the same extent in their primary outcome measures 
from baseline to discharge than patients whose treatment approach did not 
include GyroStim. 
 
23.2 Sample Size Justification:  
A power analysis was performed with an alpha value of 0.05 and power of 
0.95 with an estimated large effect size of 0.80, and a sample size 116 total 
(58 in each group) was determined to have the power to show a 2-tailed 
difference between these two groups given a matched paired design. The 
power analysis was performed using G*Power. To account for 
disqualification or dropouts, an additional 12 participants (10% attrition rate) 
will be recruited for a total of 128 participants. 
 
23.3 Statistical Methods:  
 
Descriptive statistics, including means/standard deviations and 
frequency/proportion as appropriate, will be calculated for demographic 
variables (e.g., age, gender, time from onset) and for the outcome 
measures at baseline and discharge. Group differences between the 
Standard and SMART groups for each of the outcome measures will be 
analyzed using Repeated Measures ANOVAs. 
 
 

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Statistical Power: 
The primary objective and statistical analysis of the study remain 
unchanged; therefore, there is no need to reassess statistical power. The 
primary analysis will continue to compare Group 1 versus Group 2, as 
outlined in the original hypotheses. All patients in Group 2 will be combined 
for comparison to Group 1. 
 
Treatment Frequency Selection: 
The request to allow participant self-selection into 2, 3, or 4 sessions per 
week does not alter the primary endpoint or the primary Group 1 versus 
Group 2 analysis. The statistical structure of the study remains unchanged. 
Allowing this range of treatment frequency better reflects real-world clinical 
application of GyroStim. In routine practice, patients may be treated as 
infrequently as once per week or as frequently as ten times per week (e.g., 
twice daily), depending on clinical indication and tolerance. Systematically 
capturing treatment frequency data will permit exploratory analyses to 
evaluate potential dose–response relationships (as observed in the Fox 
study) between treatment frequency and clinical outcomes. These data may 
inform optimization of future protocols and guide study design aimed at 
improving therapeutic efficiency and patient outcomes. 
 
23.4 Planned Interim Analysis:  
Per the test schedule chart below, participants will be tested at the 
beginning and end of the study. 

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23.5 Handling of Missing Data:  
 
An "intention to treat analysis" will be utilized and missing data will be 
imputed with the most recent data collected. 
 
24. 
Potential Benefits to Participants 
24.1 
For patients that elect to proceed in the GyroStim Group that includes 
treatment with SMART, preliminary studies have shown benefit to 
patients with vestibular dysfunction and balance disorders. As PCS 
symptoms often include dizziness, imbalance, and symptoms of 
vestibular dysfunction, participants in this group will likely benefit with 
improved balance, reduced dizziness, and a reduction in other symptoms 
of vestibular dysfunction. Anecdotal evidence and patient testimonies 
suggest that participants in GyroStim Group may also experience 
improvement in cognitive function, reduction of headaches, reduction of 
sensitivity to motion, bright light, and loud sounds, improved sleep, and 
other persistent symptoms from mTBI.  
 

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25. 
Risks to Participants 
25.1 The reasonable, foreseeable risks for patients that elect to proceed in 
either the Control Group or the GyroStim Group, are the same. An 
increase in any therapeutic activity level can produce a temporary 
exacerbation in symptoms such as a presentation or temporary 
worsening of headache, light-sensitivity, dizziness, vertigo, disorientation, 
nausea, brain fog, difficulty with attention, memory and/or concentration, 
fatigue, neck pain, insomnia, emotional dysregulation and other 
symptoms of mTBI. It is expected that the emergence or worsening of 
mTBI related symptoms are temporary and should resolve/reduce to 
previous baseline within a few hours to a few days. While unexpected, it 
is possible that worsened symptoms could last longer or become chronic. 
 
25.2 Risk from withdrawing or delaying treatment involved in the study are 
minimal and may include the lack of resolution of symptoms that may 
have resulted from engaging in therapeutic treatment for mTBI. Data from 
patients who deviate from study timeline requirements will not be included 
in the study.    
 
25.3 If a patient becomes pregnant, they will be removed from the study. They 
may still receive standard of care treatment for their symptoms, as 
deemed best by their medical providers.  
 
25.4 The preliminary screening by a physician or nurse practitioner and 
following established inclusion and exclusion criteria provides a significant 
reduction in the risk of harm to participants. The criteria were designed to 
avoid risks that exist for certain patients that may be susceptible to more 
serious injuries or problems. It is anticipated that only minor patient 
discomfort will be experienced by some patients, and that will be 
sufficiently addressed with rest periods, slowing of therapy progression, 
or temporary halting of treatment. Additionally, the SMART run-to-run 
progression protocol, see Appendix A, and the GyroStim software 
combine to provide the patient with protection from overstimulation. The 
GyroStim collects subjective and objective patient response to each 
therapy run that can be used by the GyroStim operator to assess patient 
comfort, patient progress, and for making informed decisions for whether 
to decrease, repeat, or increase the therapy intensity on the next run. 
 
26. 
Provisions to Monitor the Data to Ensure the Safety of 
Participants 
26.1 
The investigator and sub-investigators will be checking the data at least 
weekly, if not more frequently. Should any concerning patterns or data 

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arise, discussions will be held to address these immediately. Patients are 
under continual care and monitored while at our facility(ies) undergoing 
various treatments and therapies. Adverse events or concerns for patient 
safety will be reported immediately to the principal investigator or sub-
investigators. 
26.2 
Should a subject’s symptoms worsen and not reduce prior to continuing 
their next SMART, PT or ST/CRT, the providers will discuss with the 
patient the extent of their worsened symptoms and how to best proceed 
in the best interest of the patient. Two possibilities may then happen. 
First, treatment and therapy will continue as scheduled, with a slower or 
less demanding treatment plan of progress, i.e. few runs or slower 
speeds in GyroStim or fewer or less strenuous exercises or activities in 
PT. The second possibility is to alter the patient’s care plan in their best 
interest, with fewer visits, extended time between visits, or stopping 
treatment or therapy all together. Should this occur, the subject will be 
removed from the study, and they will continue treatment as most 
appropriate for their current status and condition.  
26.3 
Should a patient worsen beyond what is expected, or develop new, 
unexpected symptoms, they will be removed from the study and the 
principal investigator should be notified as soon as possible. Any 
development serious enough to warrant emergency room or urgent care 
visits will be reported to the IRB. Also, any unexpected symptoms that 
develop that are not related to a known, current health condition of the 
patient will also be reported to the IRB. These will be reported as soon 
as possible, typically within the next business day. 
26.4 
Development of concerning data or patterns will also be relayed to the 
IRB and participating and potential subjects as necessary and required.  
 
27. 
Economic Burden to Participants 
27.1 
This study is not sponsored by outside entities or funded by a grant. 
Patients will incur normal medical costs, depending on their insurance 
coverage or self-pay means. SMART treatment is not currently covered 
by insurance among payors in the region served by Neuroscience Group, 
and as such is a self-pay (cash pay) treatment. For those that choose to 
participate in the SMART intervention group, the cost is $149 per session 
for the first 9 sessions. The 10th session will be free. This brings the total 
out of pocket cost to $1341 for GyroStim Group participants. We 
understand that the out-of-pocket cost may be a hindrance for 
participation, and it does economically limit the number of patients that 
are able to participate in the SMART arm of the study. However, current 
cost-analysis for Neuroscience Group, our cost per patient is $1331.06 for 
10 sessions. This is based on current average patient load, space, 
equipment, depreciation, and staff costs for all aspects of GyroStim care. 

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For reference, specialized PT self-pay cost averages $125 per visit, with 
minimal specialized equipment. 
 
 
 
 
 
28. 
Resources Available 
28.1 This is a private medical practice with a specific and advertised concussion 
program. In 2024, nearly 530 new concussion patients were seen at 
Neuroscience Group. This clinic has had the GyroStim equipment and 
SMART treatment available since Q3 of 2023, and to date have completed 
treatment for approximately 50 patients, with more in progress. This 
treatment program has been gradually introduced to the public. Given the 
inclusion and exclusion criteria, we believe we will be able to recruit 
adequate numbers of patients for both groups.  
 
28.2 As study participants are also patients, they will be treated as necessary. 
We anticipate approximately 3-4 hours each week on average, per patient.  
  
28.3 This is a large, private medical clinic with 2 main locations in Appleton and 
Neenah, Wisconsin. We have 58 licensed providers and 140 additional 
care team personnel and staff to assist with reception, phone calls, billing, 
IT, HR, public relations, etc. The Appleton location has approximately 
31,225 square feet, including 41 exam/treatment rooms. The Neenah 
location has approximately 38,920 square feet with 58 exam/treatment 
rooms. All exam/treatment rooms are appropriately equipped to care for 
our patient population. There is an appropriately equipped physical therapy 

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gym that will be utilized at the Appleton location that is approximately 
1,269 square feet.  
 
28.4 As appropriate and necessary, patients will be treated in-house if medical 
or psychological (we have a licensed social worker on staff) issues arise. If 
a medical emergency arises, protocols and licensed personnel are in place 
to deal with the emergency until 911 emergency personnel arrive to take 
the patient to the hospital ER. No significant medical or psychological 
issues are anticipated to arise, as our SOC is well-established for 
treatment, and GyroStim is a non-significant risk device.  
 
29. 
Multi-Site Research 
29.1 All research will be conducted at one of the Neuroscience Group clinics, 
one located in Neenah, WI and the other located in Appleton, WI. The two 
locations are approximately 10 minutes apart, and providers and 
supporting clinical staff travel between the two locations, depending on the 
day. Recruitment will occur at both locations, as well as speech therapy. 
All physical therapy will occur at the Appleton location. Participants’ 
schedules will determine their new patient visit location and speech 
therapy location.  
 
30. 
 Retrospective Study 
30.1 
Retrospective data will be collected on all patients 18 years and older that 
started SMART (GyroStim) at Neuroscience Group between 1/1/2024 and 
12/31/2025, with a diagnosis of post-concussion syndrome.  
30.1.1 These patients will be identified using the GyroStim software to 
generate a report on all patients that are under the “concussion” 
group, and then further evaluated using patient records available in 
EPIC from there to see if they fit the inclusion and exclusion criteria 
as listed in section 5. However, no PHQ-4 questionnaire was 
completed by these patients, and therefore, will not serve as an 
exclusionary criteria.   
30.2 
All data will be de-identified, i.e. name, date of birth, address, email, 
phone number, or medical record number. No identifying data will 
transmitted or shared. This information will only be in a secured Key 
document, linking randomly generated ID numbers with patient identifying 
data. Only the PI and sub-investigators will have access to this Key 
document, which will be destroyed once the study is complete.  
30.3 
Data collected to be analyzed will include age, gender, date of 
concussion, history of previous concussion if known, any pre- and post-
testing done to include PCSS, Hit-6, FGA, NDI, DHI, mCTSIB, when post-
testing was done, if patient completed SMART, if there was a reason 
given for stopping, if the patient continued with more than 10 sessions, 

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and if patient was doing additional therapies for concussion, what those 
therapies were and if they were completed prior, during or after SMART. 
30.4 
All data will be grouped and analyzed, assessing for SMART therapy 
effectiveness as an intervention for PCS, timing of utilizing SMART after 
injury, impact of other therapies, and patterns of patient compliance and 
tolerance. Data will be shared with Courtney Hall, PhD, Professor 
Emeritus at Eastern Tennessee State University for statistical analysis. 
Specific statistical testing is yet to be determined, and will be dependent 
on the data that is gathered. 
30.4.1 This data will be used to inform and improve patient care using 
SMART for the treatment of PCS. We hope to use the data to 
determine if there is an optimal timing for utilizing SMART, if there 
are patient sub-groups (age, gender, other therapies, etc.) that this 
therapy is more or less beneficial for, and if there is benefit to more 
or less sessions of SMART. We will look to see if there are other 
conclusions that can be gleaned from the data that may determine 
how we approach using SMART for patients. Thus, it may be 
shared with other providers that utilize SMART for their patient 
care. It will likely be used by UltraThera Technologies to approach 
CMS for seeking an ICD-10 (International Classification of 
Diseases 10th Revision)  code for SMART and used by providers to 
assist with negotiating insurance reimbursement, if appropriate.  
 
31. 
Statement on Ethical Considerations 
31.1 
Study will be conducted according to ethical principles stated in the 
Declaration of Helsinki (2024), and ethics approval will be obtained prior 
to conducting this study from Pearl IRB. 
31.2 
All participants will be provided with comprehensive information about 
the study, procedures, purpose, benefits and risks. Written informed 
consent will be obtained from all participants and will take into 
consideration the well-being and freewill of all participants, voluntary 
participation and withdrawal for any reason without penalty, and the 
respect of privacy. Participants will remain anonymous in any and all 
publications, and all personal data will remain confidential and secure. 
Personal, identifying data will be removed from data sets prior to 
analysis and distribution.   
31.3 
Careful consideration was taken to in the study design and potential 
harms were assessed, with care was taken to minimize risks to ensure 
participant safety and wellbeing.  
 
 
 
 
 
 
 
 
 

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(2019). Correlation between Ocular and Vestibular Abnormalities and 
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Neuroopthalmology, 2020 June 40(3), 157-167. 
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32. 
Appendices 
 
A. GyroStim Run-to-Run Progression Flow Chart 
B. Post-Concussion Symptoms Scale (PCSS) 
C. Headache Impact Test (Hit-6) 
D. Neck Disability Index (NDI) 
E. Dizziness Handicap Inventory (DHI) 
F. Functional Gait Assessment (FGA) (2016) 
G. Modified Clinical Test of Sensory Interaction in Balance (CTSIB-m) (2013) 
H. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) 
I. Rivermeade Post-Concussion Symptom Questionnaire 
J. Patient Health Questionnaire -4 (PHQ-4) 
K. Pregnancy Questionnaire for potential female research subjects 
L. Pregnancy Test Results for potential female research subjects 
M. Comparative Clinical Outcomes of Physical Therapy Versus Physical Therapy 
Combined With GyroStim for Treatment of Post-Concussion Syndrome: A 
Retrospective Case Series 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix A 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Concussion Syndrome  
 
 
 
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Appendix B 
 
 
 
 
 

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Appendix C 
 
 
 
 
 

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Appendix D 
 
 
 
 

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Appendix E 
 
 
 
 
 

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Appendix F 
 

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Concussion Syndrome  
 
 
 
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Appendix G 
 

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Appendix H 
 
 
 
 

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Appendix I 
 
 
 
 
 
 

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Appendix J 
 
 
 
 
 

PROTOCOL TITLE: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) for Post-
Concussion Syndrome  
 
 
 
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Appendix K 
 
 
 
 

PROTOCOL TITLE: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) for Post-
Concussion Syndrome  
 
 
 
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Appendix L 
 
 
 
 

PROTOCOL TITLE: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) for Post-
Concussion Syndrome  
 
 
 
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Appendix M 
Comparative Clinical Outcomes of  
Physical Therapy Versus Physical Therapy Combined With 
GyroStim 
for Treatment of Post-Concussion Syndrome: A Retrospective 
Case Series 
 
Introduction 
A targeted, multidisciplinary, symptom-specific rehabilitation regimen is currently 
regarded as the standard of care (SOC) for individuals experiencing persistent 
symptoms following mild traumatic brain injury (mTBI) or concussion. This 
retrospective case series evaluates comparative outcome data from patients 
treated with SOC alone versus SOC supplemented with multimodal 
neurorehabilitation delivered via GyroStim (GyroStim). The objective of this 
analysis is to evaluate whether GyroStim is associated with differences in 
rehabilitation rates in patients with post-concussive symptoms.  
Methods 
This comparison utilized retrospective clinical chart review data from adult 
patients with a documented history of mild traumatic brain injury (mTBI) and a 
confirmed diagnosis of post-concussion syndrome. Due to the retrospective 
design, small SOC sample size, lack of randomization, and unequal group sizes, 
findings should be interpreted as associative rather than causal.  
Outcome Measures 
Vestibular dysfunction is a common sequela of mTBI, therefore outcomes were 
evaluated using the Dizziness Handicap Inventory (DHI), a validated patient-
reported measure of vestibular-related symptom severity and functional impact. 
Baseline and discharge DHI scores were collected to quantify change over the 
course of treatment and to calculate therapeutic dose–response (change in DHI 
divided by the treatment duration (weeks)).  
Standard of Care 
All patients underwent similar intake protocols, received balance education, and 
were prescribed standardized home exercise programs. All patients completed 
standardized pre- and post-intervention testing using the DHI assessment. All 
patients received SOC consisting of therapy programs designed to address 
identified concussion-related impairments, including individualized and targeted 
physical, vestibular, and vision therapies. 
GyroStim Intervention 
GyroStim is a computer-controlled, multi-axis rotational chair designed to deliver 
multimodal neurorehabilitation protocols. It is an FDA-cleared medical device 
with Breakthrough Device designation for balance disorders and vestibular 
dysfunction indications.  

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Concussion Syndrome  
 
 
 
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A subset of all patients received GyroStim multimodal neurorehabilitation 
treatment in addition to SOC (GyroStim). Half of the GyroStim group received 
High-Density GyroStim treatment defined as ≥4 sessions per week, and the other 
half received Low-Density GyroStim treatment defined as <4 sessions per week.  
 
Data Analysis 
Patient data was analyzed in three different ways as described and documented 
below.  
1. DHI Outcome Comparison 
Data collected from the patient charts was analyzed to look at DHI outcomes for 
all patients and to compare differences between patients who were treated with 
SOC alone versus patients who were treated with GyroStim in addition to SOC. 
Table 1. Dizziness Handicap Inventory (DHI) outcomes for All Patients and 
Groups 
 
Variable 
All 
patients 
(n=19) 
GyroStim + 
SOC (n=15) 
SOC* 
(n=4) 
Significance** 
(p-value) 
Baseline DHI (/100) 
46 ± 20 
48 ± 21 
36 ± 13 
0.29 
Discharge DHI (/100) 
30 ± 24 
35 ± 25 
14 ± 12 
0.14 
Change in DHI (/100) 
15 ± 18 
14 ± 19 
22 ± 13 
0.45 
Number of PT visits 
8.3 ± 5.6 
6.9 ± 5.5 
13.5 ± 
2.4 
0.03 
Treatment duration 
(wks) 
8.1 ± 6.4 
6.7 ± 6.3 
13.0 ± 
4.2 
0.08 
* Interpret group comparisons cautiously due to small SOC sample size 
** Group differences between GyroStim + SOC compared to SOC 
 
Key Findings 
• All patients, GyroStim and SOC groups, showed a significant improvement 
in DHI (means ± SD: pre-therapy DHI = 46 ± 20, post-therapy DHI = 30 ± 
24; p = 0.003).  
• There were significant group differences in the number of PT visits 
(GyroStim: 6.9 ± 5.5 vs. SOC: 13.5 ± 2.4; p = 0.03). 
• There was a trend for differences in treatment duration (GyroStim: 6.7 ± 
6.3 weeks vs. SOC: 13.0 ± 4.2 weeks; p = 0.08).  
 
 
 
 
2. GyroStim Treatment Density & Therapeutic Dose-Response 

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Concussion Syndrome  
 
 
 
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Data collected from the patient charts was analyzed to evaluate the relationship 
between GyroStim treatment density and therapeutic dose-response. 
Table 2. Low-Density GyroStim Therapy (<4 sessions/week) vs. High-
Density GyroStim therapy (≥4 sessions/week) 
 
Variable 
Low-Density 
(n=8) 
High-
Density* 
(n=7) 
Significance** 
(p-value) 
Baseline DHI (/100) 
48 ± 26  
48 ± 17 
0.99 
Discharge DHI (/100) 
36 ± 30 
33 ± 19 
0.78 
Change in DHI (/100) 
12 ± 18 
16 ± 21 
0.72 
Number of PT visits 
4.1 ± 2.6 
9.2 ± 6.3 
0.07 
# GyroStim sessions (n) 
12.3 ± 4.3 
13.2 ± 7.7 
0.77 
Treatment duration (wks) 
11.5 ± 4.8 
1.3 ± 0.5 
< 0.001 
Therapeutic Dose-Response † 
(in DHI units) 
0.8 ± 2.1 
12.9 ± 13.4 
0.025 
† Therapeutic Dose-Response = Change in DHI/Treatment duration in DHI units 
 
*High-Density protocols involved up to two sessions per day delivered over 
consecutive days 
 
** Group differences between Low-Density (<4 sessions/week) compared to 
High-Density (≥4 sessions/week) GyroStim 
 
 
Key Findings 
• For the GyroStim group, there was a significant correlation (p = 0.03) 
between treatment density (# sessions/week) and TDR (TDR; r = 0.57; 
moderate to good strength of correlation). For the SOC group, there was a 
moderate to good correlation (r = 0.56) between # PT visits and TDR. 
• Based on the correlation between treatment density and TDR, patients 
receiving GyroStim treatment were grouped into Low-Density (< 4 
sessions/week) and High-Density (≥ 4 sessions/week) for comparison.  
• Between these two groups, there were no significant group differences in 
terms of Pre-therapy DHI, Post-therapy DHI and DHI Change (p > 0.05).  
• There were significant group differences for treatment duration (Low-
Density: 11.5 ± 4.8 weeks vs. High-Density: 1.3 ± 0.5 weeks; p < 0.001) 
and TDR (Low-Density: 0.81 ± 2.1 DHI units/week vs. High-Density: 12.9 ± 
13.4 DHI units/week; p = 0.025). 

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Concussion Syndrome  
 
 
 
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3. High-Density GyroStim Treatment vs SOC 
Based on the significant findings in Table 2 that High-Density GyroStim treatment 
results in substantially greater TDR and faster rate of improvement than Low-
Density, Table 3 compares differences between High-Density GyroStim 
treatment and SOC. 
Table 3. High-Density GyroStim Treatment vs SOC 
 
Variable 
SOC 
(n=4) 
High-Density 
(n=7) 
Significance* 
(p-value) 
Baseline DHI (/100) 
36 ± 13 
48 ± 17 
0.24 
Discharge DHI (/100) 
14 ± 12 
33 ± 19 
0.13 
Change in DHI (/100) 
22 ± 13 
16 ± 21 
0.63 
Number of PT visits 
13.5 ± 2.4 
9.2 ± 6.3 
< 0.001 
Treatment duration (wks) 
13.0 ± 4.2 
1.3 ± 0.5 
< 0.001 
Therapeutic Dose-Response (in 
DHI units) 
1.6 ± 0.6 
12.9 ± 13.4 
0.13 
* Group differences between High-Density GyroStim treatment compared to SOC  
 
 
Key Findings 
• Comparing High-Density GyroStim treatment to SOC, there was a 
significant difference in treatment duration (High-Density: 1.3 ± 0.5 weeks 
vs. SOC: 13.0 ± 4.2 weeks; p < 0.001) and number of PT sessions (High-
Density: 9.2 ± 6.3 vs. SOC: 13.5 ± 2.4; p < 0.001). 
• Comparing SOC to High-Density treatment, there is a non-significant trend 
for differences in TDR (High-Density: 12.9 ± 13.4 DHI units vs. SOC: 1.6 ± 
0.6 DHI units; p = 0.13).  
 
 
Summary of Findings 
• 
All patients, GyroStim groups and SOC group, showed a significant 
reduction in symptoms.  
• 
Total number of treatment sessions was similar between groups: Standard 
of Care (SOC) and GyroStim groups (≈13 sessions each). 
• 
GyroStim showed trends toward greater treatment efficiency. 

PROTOCOL TITLE: Sensorimotor Multi-axis Automated Rotational Therapy (SMART) for Post-
Concussion Syndrome  
 
 
 
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• 
Increased treatment density was significantly associated with faster rate of 
rehabilitation in the GyroStim group.  
• 
High-Density GyroStim treatment markedly accelerated rate of 
rehabilitation. 
o No significant differences in baseline, discharge, or total DHI 
change, indicating similar overall symptom improvement although 
the High-Density group demonstrated a significantly faster 
rehabilitation rate. 
• 
High-Density GyroStim demonstrated substantially improved rehabilitation 
efficiency compared to SOC. 
 
Conclusion 
GyroStim Is Associated With Up To 8 Times Faster Rate of Rehabilitation 
Than Conventional Physical Therapy Alone 
This retrospective clinical chart review compares SOC physical therapy alone to 
GyroStim combined with SOC and reveals substantial differences in the rate of 
rehabilitation between the groups. Despite similar total numbers of treatment 
sessions and comparable overall symptom improvement, patients in the High-
Density GyroStim treatment group experienced rehabilitation rates an average of 
8 times faster, underscoring that GyroStim’s primary advantage is the speed and 
efficiency with which concussion recovery may be achieved. 
A statistically significant therapeutic dose-response relationship was observed: 
increased frequency (density) of GyroStim treatment is associated with faster 
rehabilitation rates, i.e., increasing treatment density increases efficiency. In 
practical terms, this suggests that GyroStim does more than enhance SOC 
rehabilitation; it has the potential to substantially compress recovery timelines, 
reduce overall treatment duration, and enable patients to return to normal 
function far sooner than conventional therapy alone. 
Collectively, these findings position GyroStim as a high-efficiency 
neurorehabilitation accelerator, capable of delivering comparable clinical 
outcomes approximately eight times faster than SOC alone when applied at 
sufficient treatment density. Within the limitations of small sample size and 
retrospective design, these results warrant prospective controlled studies and 
suggest a potential shift in expectations for recovery speed and therapeutic 
efficiency in post-concussion rehabilitation.