A Pilot Study of Neubie, a Direct Current Electrical Stimulation Device, to Inhibit Lower Extremity Spasticity Levels and Normalize Muscle Functional Use During Transfers and Ambulation in Individuals With Multiple Sclerosis
Phase: NA
Conditions: Multiple Sclerosis
Sponsor: CommonSpirit Health

 
 
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Protocol Title, Version Number, and Version Date 
Protocol Version Number:3 
Protocol Version Date: 5/24/22 
IRBNet ID: 1643900 
 
Investigators 
 
Principal investigator: Courtney Ellerbusch, PT, DPT 
Cell-303-905-8272 
Secondary investigator: Dr. Julie Seibert, MD 
Work-303-730-2883 
 
 
Funding Source 
NeuFit is funding costs associated with IRB review board, Statistician fees 
and Hoffman’s reflex testing. The primary investigator is not accepting 
any personal compensation. 
 
Objectives and Hypothesis(es) 
 
The hypothesis we hope to test is if treating individuals with multiple sclerosis 
(MS) at the peripheral nervous system (PNS) level in golgi tendon organ and 
muscle spindles using a direct current through the NeuBie electrical stimulation 
device can inhibit spasticity and improve functional mobility in clinically 
significant measures. There are two significant structures within the PNS that have 
a significant impact on spasticity level closely monitored by the central nervous 
system (CNS). These structures are muscle spindles within the body of all skeletal 
muscle and golgi tendon organs within the muscle tendons. These structures when 
functioning normally within a fully intact neurological system are protective against 
over stretch in muscle, or tendon and bone injury causing reflexive counterforce or 
dropping a weight that is too heavy. In an individual with MS the CNS is over-
protective and causes the threshold for stretch reflex and muscle tightness to be set 
lower than normal. This inhibits normal movement and causes abnormalities in 
posture, stiffness and at times joint contractures. In this pilot study we hope to 
assess the ability for the direct current of NeuBie, which creates mechanoreceptor 
inputs and lengthening at the sarcomere level of muscle and joints in the spine and 
lower extremity, to alter the proprioceptive PNS at muscle spindle and GTO level 
with a change in CNS over-guarding during the treatment and after the treatment. If 
we are able to create normalized stretch and muscle tension at the PNS level, it may 
be possible to create temporary or sustained CNS level changes. This would allow 
the amount of stretch and tension at the PNS level to be normalized and possibly 
reduce spasticity. If this theory is accurate, we may be able to increase access to 

 
 
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normalized movement, strength and functional ability in individuals with neuro-
compromise.  
 
Approximately 66%6 to 84%1 of individuals with multiple sclerosis experience 
various levels of debilitating spasticity6 limiting freedom of movement at ankles, 
knees and hips causing deficits in ambulation, weakness from disuse of muscles not 
accessible due to spasticity. Per the North American Research Committee on 
Multiple Sclerosis1, a survey was conducted on spasticity prevalence and results 
show 84%1 have some degree of spasticity from mild to incapacitating. Spasticity 
pathophysiology is complex and not completely understood with higher levels of 
incapacitating spasticity reported in this survey by those who were male, disabled 
and unemployed1, indicating that psychosocial and subjective variables are 
significant. The pathophysiology currently best understood demonstrates an 
imbalance between inhibitory dorsal reticulospinal tract (RST) fibers and excitatory 
bulbopontine tegmentum. RST neurons receive direct somatic, vestibular, tectal, 
cerebellar and motor excitatory input and are scattered in the ventral and lateral 
spinal cord columns intermingled with propriospinal fibers1. The peripheral Golgi 
tendon organ of muscle tendon and muscle spindle intrafusal fibers ubiquitous 
throughout the musculoskeletal system have direct monosynaptic connection to 
these central nervous system propriospinal fibers and heavily influence the degree 
of spasticity and overactive stretch reflexes1,10.  
 
 
Those who deal with all levels of spasticity use compensatory movement 
strategies causing altered arthrokinematics and have loss of strength, balance and 
efficient muscle use with postural changes. Spasticity management has been studied 
and treated from a pharmaceutical standpoint with some improvements but often 
side effects including fatigue, muscle weakness and cognition limit dosing in oral 
Baclofen, Dantrolene Sodium, Tizanidine and Benzodiazepines1. Marijuana 
especially in form of cannabinoids shows mixed evidence for spasticity 
improvement and is a growing area of interest. There is a growing CBD interest in 
the MS population due to known reduction of CNS neurodegeneration in animal 
MS studies and no significant negative side effects with possible mild to moderate 
improvement in spasticity levels1. Therapy interventions offered include frequent 
stretching especially of muscles that cross two joints including lumbricals, 
hamstrings, gastrocnemius and iliopsoas; light stroking over lower limbs 
demonstrated a 30% decrease in H-reflex amplitude lasting even 30 minutes after 
treatment; muscle cooling was shown to reduce muscle stretch activity and clonus; 
Armutlu et al. Reported significant reduction in plantar flexor spasticity in 10 
patients with MS using high-frequency (100Hz) TENS for 20min daily for 4 weeks. 
Reduction noted on Modified Ashworth Scale (MAS), electrophysiologic 

 
 
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measurements and the AI; and serial casting performed over a 9-day period with 
cast changes every 3 days demonstrated reduced spasticity levels1.  
 
 
 
 
Background/Scientific Rationale and Significance 
 
The NeuFit company offers a NeuBie EMS product with a direct current using high 
fidelity audio equipment to decrease intensity of the treatment noxious stimulus and 
protect skin integrity from burns or intolerable pain. This system uses an 
exponential wave pattern to mimic the natural pattern neurologically to lengthen 
fibers of the sarcomere and engage force velocity of muscle with minimized 
protective co-contraction of nearby muscle groups9. The golgi tendon and muscle 
spindles code for joint position and muscle/tendon stretch with 66% of fibers being 
intrafusal.  Impacting these structures has direct impact on reticulospinal tract 
(RST) fibers and proprioceptive central fibers modulation of levels of spasticity. 
However, finding effective means to impact these areas is difficult.  The NeuBie 
direct current is designed to improve positioning of these stretch receptors.  As 
discussed within the paper hypothesis, the theory is that this may improve spasticity 
levels as well as agonist strength enough to create long term, significant functional 
improvement.  
 
Dr. Terry Wahls who has MS and has studied and marketed a protocol for MS 
treatment, promotes this product and has a home unit she uses daily to control her 
own MS symptoms and gain strength.  Currently there is no research study 
conducted on the effects of the NeuBie direct current treatment combined with 
exercise and ramifications of spasticity in multiple sclerosis. There have been only a 
few studies conducted with quantitative spasticity measures mostly with FES and 
NMES targeting tibialis anterior and quadriceps to lessen plantar flexor spasticity10 
in spinal cord injury (SCI) and hemiplegia. In the SCI study Mirbagheri et al. 
observed decreases in intrinsic and reflex dynamic stiffness in all 4 subjects studied 
over a 16-month period. Robinson et al. stimulated quadriceps muscle pulse 
duration 500, 20 Hz and amplitude of 100 with spasticity quantitatively reduced 
immediately after stimulation but return of baseline spasticity level when measured 
24 hours later10. Levin and Hui-Chan assessed sensory level stimulation of the 
common peroneal nerve for a total of 15, 60 min sessions for 3 weeks in people 
with hemiplegia using pulse duration 125 continuously at 99Hz and observed 
inhibition of H-reflex at soleus, increase in dorsiflexion voluntary force and 
reductions in stretch reflex at triceps surae10. 
 
         The NeuFit method of treatment allows the recipient to voluntarily 
concentrically or eccentrically activate muscles while receiving the direct current 
passive eccentric input. In order to assess the feasibility of this papers’ hypothesis 
we will perform a pilot study of up to 9 individuals with MS in the greater Denver 
metro area. At the time of the study we are in a global pandemic and the safest path 

 
 
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forward is a design with one patient receiving treatment at a time for infectious 
precautions.  
  
 
Inclusion and Exclusion Criteria 
 
Dr. Julie Seibert will screen all potential participants for the following inclusion and 
exclusion criteria prior to making a referral for participation in the study. 
 
Inclusion criteria 
1. Greater than 18 years old (no upper age limit) 
2. Physician diagnosed MS (As stated in Rooney S, et al. Disabil Rehabil. 
2019, stage of MS did not impact individuals from making neuromuscular 
or functional gains. All stages of MS will be eligible) 
3. Physician clearance to participate 
4. Unable to ambulate more than 150 feet at a time and unable to ambulate 
within the home or outside the home without the use of an assistive 
device. 
5. BLE MMT in hips, knees and ankles <=3/5  
6. Modified Ashworth assessed spasticity levels 1-4 
 
 
 
 
Exclusion criteria (based on recent FES studies Backus 2017 and Szecsi 2009) 
1. Co-morbidities in cardiovascular disease (myocardial infarction in past 
1-year, unstable angina, CHF, h/o arrythmia, h/o CVA or TIA in past year, 
uncontrolled hypertension) 
2. History of epileptic seizures 
3. Lower Motor Neuron disease 
4. Existing pacemaker, defibrillator or other implanted device (other than 
baclofen pump) 
5. Unstable long bone fractures of lower limb or trunk 
6. Allergies to surface electrodes or conductive gel 
7. Pregnancy or actively seeking to become pregnant 
 
 
Vulnerable Populations 
No vulnerable populations to be studied. 

 
 
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Number of Subjects 
 
This will be a pilot study using a series of up to 9 case studies for up to 9 
participants. All studies will be completed entirely from the subject’s home 
with CSHRI IRB oversight. 
 
 
Recruitment Methods 
 
Dr. Julie Seibert will recruit participants who meet inclusion and exclusion criteria from 
her database. If Centura Health at Home receives a referral who may be a fit and is 
interested in participation, we will have this participant screened through Dr. Siebert’s 
office to ensure fitness and safety to participate. Participants will be contacted by 
telephone or mail from Dr. Seibert. Only approved researchers are allowed to participate 
in study related activities. 
 
Telephone Script: 
"Hello Mr or Mrs. X, my name is Courtney Ellerbusch and I am a doctor of physical therapy who 
works for Centura Health as a home health physical therapist with a personal interest in the 
multiple sclerosis population. [Dr.Seibert, a local neurologist specializing in multiple sclerosis] or 
[Our agency has identified you] as a potential candidate to participate in a small Pilot study to 
assess an electrical stimulation's device effectiveness on your multiple sclerosis symptoms. Are 
you interested in being considered as a participant? If so, Dr. Seibert will review your health 
record to ensure you fit our patient parameters for safe participation.” 
 
If the answer is “Yes”- Arrangements will be made for the potential participant to have an 
appointment with Dr. Seibert to sign the consent form, objective measures and assessment 
along with a Hoffman’s reflex assessment by Dr. Dan Koontz. Dr. Seibert will generate a referral 
to Centura Health at Home for the primary investigator to evaluate and treat per the study 
parameters. 
 
If the answer is “No”- The individual will be thanked for their time and not contacted again for 
purposes of study participation. 
 
Mail Prose: 
DATE: X 
TO: Potential Participant X 
PROJECT TTTLE: [1643900-1] A Pilot Study of NeuBie, a direct current electrical 
stimulation device, to inhibit lower extremity spasticity levels and normalize muscle 
functional use during transfers and ambulation in individuals with multiple sclerosis. 
 
Dear “X”, 
 
Dr. Courtney Ellerbusch, a field staff physical therapist from Centura Health at Home, and Dr. 
Julie Siebert from Colorado Neurodiagnostics are formally contacting you to request your 
participation in a Pilot study for multiple sclerosis. There is no pressure to participate and 
whether or not you choose to be involved, no changes will occur to your healthcare or insurance 
standings. 
 

 
 
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The format of this study has undergone rigorous review for safety and compliance parameters 
with the CommonSpirit Health Research Institute Institutional Review Board (CSHRI IRB) for 
your safety.  
 
The study will require up to 10 weeks of various form of appointments, testing and active therapy 
participation. Specifically, you will need an initial appointment with Dr. Seibert to understand and 
sign our consent form as well as initial testing in EDSS, then you will be arranged in same office 
on same day to see Dr. Dan Koontz for H-reflex testing. Once these steps are complete, you will 
be referred by Dr. Seibert to Centura Health at Home to work with Dr. Courtney Ellerbusch for 
visits 3 times per week over a period of 6 weeks. She will come directly to your home for all 
portions of treatment and assessments.  Dr. Ellerbusch will perform testing and treatment using 
an FDA approved direct current electrical stimulation device and exercise, stretches and a form 
of manual therapy known as primary and secondary activations. Once the treatment portion of 
the study is complete you will need to have a follow-up appointment with Dr. Seibert and Dr. 
Koontz for re-testing. 
 
1. If you would like to consult further prior to making a decision please contact the primary 
investigator directly: 
a. Dr. Courtney Ellerbusch, PT, DPT 
303-905-8272 
courtneyellerbusch@centura.org 
 
2. If you are certain you would like to be a participant, please call Colorado Neurodiagnostics 
directly to arrange an initial appointment with Dr. Julie Seibert. Please mention your interest 
in the Pilot study participation when calling. 
a. Colorado Neurodiagnostics (coneurodiagnostics.com) 
i. 303-730-2883 
 
Thank you for your time and consideration. 
 
 
 
 
 
 
 
 
 
Sincerely, 
 
 
 
 
 
 
 
 
 
             Courtney Ellerbusch, PT, DPT 
 
 
 
 
 
 
Study Timelines 
• All participants will be referred through Dr. Seibert. We will plan 
to start with only one participant for the first case study to ensure 
all steps completed as planned. Then the second case study is to 
begin as soon as the first one is completed and on until up to 9 case 
studies are completed. Dr. Ellerbusch will start with one 
participant at a time, then once all steps completed will be open to 
treating to 2 study subjects at a time. 
• Depending on timeline for IRB approval and Centura approval we 
hope to begin this study in the Spring of 2021 and depending on 

 
 
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number of subjects and timeliness of finishing one case study and 
starting the next we’d hope to complete the study by Winter of 
2021. 
 
Study Endpoints 
 
 
The primary study endpoint of this pilot study to assess if decrease in spasticity 
for individuals with MS is possible during NeuBie direct current treatment and for 
any length of time after treatment to further learn if this correlates to improvement 
in functional gait and transfers. The listed subjective and objective data points are 
selected to capture this endpoint. 
 
Procedures Involved 
 
Study methods: 
1. Treatment portion of study: 
2. The physical therapist will implement manual activation techniques combined 
with NeuBie and PT exercise interventions 3 times per week for 6 weeks.  
i) Use of Treatment table with manual activations to underactive, spastic or 
limited in sensory muscles/regions (The PT will consider primary and 
secondary activations to strengthen neural pathways maximally) 
ii) NeuBie Mapping mode scanning process with electrode placed on 
thoracolumbar space and second sponge electrode scanning for: 
(1) Spots that stimulate movement they couldn’t do before per initial 
assessment 
(2) Spots that allow movement which is a greater range than available before 
per initial assessment 
(3) Spots that lead to decreased spasticity (turn up amplitude and have 
participant work through the threat response then repeat) 
(4) Diminished sensation areas – drive signal to increase sensory nerves and 
become metabolically active. Consider knee, hip and ankle joints as these 
are neurologically rich. 
iii) Train using physical therapy exercises with Neubie in training mode and Hz 
current adjusted for tolerance, ability to work through or decrease spasticity in 
(500 Hz) in the following areas (spasticity, contraction, dead or diminished 
spots and hot spots) as tolerated but remove if participant is displaying signs 
of fatigue 
(1) Spasticity areas – 500Hz – adjust amplitude to 7/10 discomfort and Pt 
works through spasticity with assist from PT as needed. The muscle that 
oppose the spasticity (agonist) will be considered for 40Hz current 
adjusted no higher than 7/10 discomfort with movement patterns out of the 
spasticity. 
(2) Contraction areas -500Hz – adjust amplitude to 7/10 intensity and 
participant works with contracting muscle without altered kinematics or 
co-contraction. The muscle that oppose the spasticity (agonist) will be 
considered for 40Hz current adjusted no higher than 7/10 discomfort with 
movement patterns out of the spasticity. 

 
 
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(3) Dead/diminished areas – establish a baseline amplitude for sensation and 
leave signal on at this amplitude. Over time assess if the amplitude for 
sensation is decreased demo return of sensation. 
(4) Hot spots – assess if the same amplitude over these areas which creates 
high level of discomfort becomes less uncomfortable over time as a sign 
of increased neurological resiliency.  
iv) Continue with electrodes in place and apply with functional training in high 
kneeling, sitting, transfers, standing static, standing dynamic closed chain, 
standing dynamic open chain, gait and movements available in LE/core 
v) Progress participantin sitting balance unsupported, sit to stand, standing 
balance static and dynamic and in gait 
vi) If participanttolerates less amplitude signal next visit while working through 
spasticity or contraction, they are in neurological fatigue and consider master 
re-set, sensory inputs, stretches and more gentle approach for active recovery 
 
If participant was not receiving this intervention, they would receive traditional 
physical therapy in stretching, therapeutic exercise training open chain and closed 
chain, transfer training, gait training and balance training working within limits 
ofparticipant’s  spasticity levels. 
 
Participants in this study will participate in the listed interventions for 6 
weeks. Outcome measures objective and subjective will be collected at the 
beginning and end of the study. 
 
1. EDSS – Dr. Seibert performs (https://www.mstrust.org.uk/a-z/expanded-
disability-status-scale-edss) 
2. Hoffman’s Reflex – Dr. Dan Koontz performs (Dr. Koontz performs test only, 
then gives results to investigators.)  
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC522151/) 
3. 12 item MS walking scale –Dr. Ellerbusch performs  
https://www.sralab.org/sites/default/files/2017-07/msws-eng.pdf  
4. Manual Muscle test – Dr. Ellerbusch performs 
5. Modified Ashworth test – Dr. Ellerbusch performs 
https://www.sralab.org/sites/default/files/2017-
06/Modified%20Ashworth%20Scale%20Instructions.pdf  
6. 25 foot walk test – Dr. Ellerbusch performs 
https://www.nationalmssociety.org/For-Professionals/Researchers/Resources-for-
Researchers/Clinical-Study-Measures/Timed-25-Foot-Walk-(T25-FW)  
7. Timed up and Go –Dr. Ellerbusch performs 
https://www.cdc.gov/steadi/pdf/TUG_test-print.pdf  

 
 
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8. Multiple Sclerosis Impact Scale (MSIS-29) – Dr. Ellerbusch performs 
https://www.mstrust.org.uk/sites/default/files/MSIS-29.pdf  
 
 
Data and Specimen Banking 
No specimen collected. 
 
 
Data Analysis Plan 
 
The data in this small sample will be reported using descriptive statistics such as 
number and percent. Measures of central tendency such as mean, median and mode 
will be analyzed for trends or results. A third party, Dave Drachman, will provide 
statistical analysis based on psychometric data and objective date with minimally 
clinically significant changes for these measures. Dr. Julie Seibert will assess and 
analyze her own data measures. Dr. Dan Koontz will assess Hoffman’s reflex test 
and provide the results to Dr. Seibert and Dr. Ellerbusch. Dr. Koontz does not have 
a role in the study beyond making the Hoffman’s reflex test results available for use 
in this study. All study results will be made available to Dr. Ellerbusch, lead 
investigator. I will pass these results to Dave Drachman. All of the participants 18 
HIPAA identifiers will be protected using a numerical system per participant in all 
transmissions. 
 
 
 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
Dave Drachman, upon collection of results the protocol will be updated to when 
each case study with an individual is complete. I will also review the collected data 
after each 6-week period of working with the subject. 
 
 
Withdrawal of Subjects 
All participants will participate on an at will basis and will be allowed to 
discontinue at any time. If a participant is participating and develops an 
exclusion criterion such as pregnancy they will be withdrawn from the 
study per the disclosure notice. Forty-eight hours in advance of discharge 
from home health physical therapy and termination of the study, 
participants will sign the Notice of Medicare Noncoverage form. If a 
participant participates in part but not all of the study, data will be 
collected and stored to be determined in collaboration with statistician at 
what level their data can be used for analysis. 
 
Risks to Subjects 
This study carries very low risk to subjects. Possible risks include fatigue 
from the NeuBie device and exercises used. Subjects with comorbidities that 
would make participation unsafe will not be included in the study.  

 
 
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Potential Benefits to Subjects 
 
Relaxation of muscle spasm 
 
Decrease in spasticity 
 
Prevention or retardation of disuse atrophy 
 
Increasing local blood circulation 
 
Neuromuscular re-education 
 
Maintaining or increasing range of motion  
 
Symptomatic relief and management of chronic pain 
 
 
Sharing of Results with Subjects 
Once the subject’s participation and all required testing is complete, he or 
she may have access to their objective and subjective before and after test 
measurements. These results will be printed and mailed to the participant’s 
home address upon request. 
 
 
Setting 
Participants in study will be selected based on inclusion and exclusion 
study criteria by Dr. Seibert from her patient list. Any direct referrals to 
Centura Health at Home who may be candidates based on diagnoses and 
appearance to match criteria who are willing will be referred to Dr. Seibert 
to ensure fitness to participate in study, understanding and signing of 
consent form and initial testing.   The 3 times per week 6-week study 
treatment visits will be performed at the participant’s home.  
• Other research procedures performed from Dr. Seibert’s office and 
participants’ home. 
 
Resources Available 
Courtney Ellerbusch, PT, DPT is a field staff physical therapist for 
Centura Health at Home with 8 years clinical experience post doctorate. 
Dr. Julie Seibert, MD is a neurologist for Colorado Neurodiagnostics 
specializing in Multiple Sclerosis. Garrett Salpeter is the NeuBie founder 
and director and not performing the study, but he and his team available 
for consultation during study formation and implementation.  
Describe other resources available to conduct the research: For example, 
as appropriate: 
• Dr. Seibert has a large base of patients with Multiple Sclerosis to 
draw from as potential participants. We hope to study up to 9 
participants and this is highly feasible with her list and Centura 
connections with other local neurologists if needed. 
• Courtney Ellerbusch will treat subjects as part of her weekly 
workload with added time during visits and after visits to ensure 

 
 
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data collection and management handled carefully and well 
tracked. 
• This study will be performed from each participant’s home which 
will vary based on many factors.  
• Home Health subjects do have access to social workers, nurses, 
occupational therapists, CNAs as needed to ensure their needs are 
met. However, additional therapy would complicate results and 
participantswill be encouraged to meet additional therapy needs at 
another time or choose to not participate.  
• Direct emails and phone calls to and from Dr. Seibert and Garrett 
Salpeter to ensure all aspects of protocol communicated clearly, 
agreed upon and understood. A record of the study design is saved 
and has been sent to these individuals. 
 
Prior Approvals 
No prior approvals. 
 
Confidentiality 
Describe the local procedures for maintenance of confidentiality. 
• Data collected will be stored in Dr. Seibert’s office and Dr. 
Ellerbusch’s office for 6 years in a file folder securely located.  
• Electronic records kept on Centura server. 
• Local access to data will be available to Dave Drachman for statistical 
analysis, Dr. Seibert and Dr. Ellerbusch. 
• Receipt and data transmission locally will be managed by Dr.  
Ellerbusch and Dr. Seibert 
• Dr. Ellerbusch will keep written and electronic records of data in her 
car for transport from field to secure home office. 
Data will be kept private and confidential on secure laptop managed by 
Centura.  
Provisions to Protect the Privacy Interests of Subjects 
Participants’ privacy interests will be protected through HIPAA law and 
regulation and researchers will not divulge any private information to 
anyone other than the subject at the end of the study. 
Participants will be given opportunity prior to committing to participate 
and throughout the study to understand the purpose of the study, possible 
risks and possible benefits along with their roles and responsibilities.  
The research team shall be granted access to subjects’ medical records, 
home address, phone number, insurance coverage and all of this will be 

 
 
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kept confidential and used only for the purpose of subject safety as well as 
fitness to participate in the study. 
 
Economic Burden to Subjects 
Participants will be responsible for any co-pay insurance cost for visits 
with Dr. Seibert and home health agency visits at a frequency of 3 times 
per week for 6 weeks.  
 
Consent Process 
All subjects will be given a consent form with explanation and review to 
sign. 
• Consent to participate form will be signed from Dr. Seibert’s office 
during initial screening. Informed consent will be obtained prior to any 
research related screening procedures. 
• Subjects will be informed of their right to discontinue participation at 
any time. 
Non-English Speaking Subjects 
• Spanish speaking participants are welcome and the primary researcher 
speaks clinical Spanish.  
• If a Spanish speaking subject wishes to participate, oral and written 
information in their language will be provided. The CryaCom 
interpreter language line is available for use to ensure communication 
is understood.  
 
Process to Document Consent in Writing 
Signed consent forms for Centura Health at Home will be sent via secure 
Tiger Text to Judy Deherrera of CHAH operations for their record and 
kept in secure electronic records. This is the standard of practice for 
Centura Health at Home. Research consent forms will not be sent via 
Tiger Text. The research consent form will be kept securely in a lock box 
within the office of Courtney Ellerbusch, PT, DPT. 
 
Drugs or Devices 
The NeuBie electronic stimulation device will be stored in the office of 
Courtney Ellerbusch outside of visits, transported in her car to visits and 
electrodes used by participantwill be kept in the participant’s home. All 
aspects of the device that may come into contact with the subject or home 
will be sanitized between visits. 
 
 

 
 
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References: 
 
 
1. Brashear A, Elovic E. Spasticity: Diagnosis and Management. In: Shah A, Maitin I ed. 
Spasticity Due to Multiple Sclerosis: Epidemiology, Pathophysiology and Treatment. 
New York, NY: Demos Medical Publishing; 2011: 341-352. 
2. Backus et al. Outcomes After Functional Electrical Stimulation Cycle Training in 
Individuals with Multiple Sclerosis Who Are Nonambulatory: A Pilot Study. 
International Journal of MS Care. 2017. 
3. Etoom et al. Effectiveness of Physiotherapy Interventions on Spasticity in People with 
Multiple Sclerosis: A Systematic Review. American Journal of Physical Medical 
Rehabilitation. 2018. 
4. Wahls, T., Reese, D., Kaplan, D., Darling, W. Rehabilitation with Neuromuscular 
Electrical Stimulation Leads to Functional Gains in Ambulation in Patients with 
Secondary Progressive and Primary Progressive Multiple Sclerosis: A Case Series 
Report. The Journal of Alternative and Complementary Medicine. 2010.  
5. Szecsi et al. Functional Electrical Stimulation-Assisted Cycling of Patients with 
Multiple Sclerosis: Biomechanical and Functional Outcome: A Pilot Study. Journal of 
Rehabilitative Medicine. 2009. 
6. Mills, P., Dossa, F. Transcutaneous Electrical Nerve Stimulation for Management of 
Limb Spasticity: A Systematic Review. American Journal of Physical Medicine and 
Rehabilitation. 2016. 
7. Meseguer-Henarejos AB, Sanchez-Meca J, Lopez-Pina JA, Carles-Hernandez R. Inter-
and intra-rater reliability of the Modified Ashworth Scale: a systematic review and meta-
analysis. European journal of physical and rehabilitation medicine. 2018 Aug;54(4):576-90. 
8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6278623/  
 
 
The quantitative evaluation method of spasticity (Table 1) are significant both for 
the treatment plan and for the measurement of response to treatment.  
9. Neubie: A New Paradigm in Electrical Stimulation. 
(https://files.constantcontact.com/24512df0601/0849a8cb-57ba-46ff-a620-
8d25d3873042.pdf) Garrett Salpeter. 
10. Robinson A, Snyder-Mackler L. Clinical Electorphysiologiy: Electrotherapy 
and Electrophysiologic Testing: Third Edition. In: Stackhouse, S. Electrical 
Stimulation of Muscle for Control of Movement and Posture. Philadelphia, PA: 
Wolters Kluwer and Lippincott Williams and Wilkins; 2008: 260-262.