Burst-Type Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease: A Pilot Study of Tolerability and Efficacy
Phase: NA
Conditions: Parkinson Disease, Deep Brain Stimulation
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

 
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Study Title:   
Burst-Type Deep Brain Stimulation of the Subthalamic 
Nucleus in Parkinson’s Disease: A Pilot Study of 
Tolerability and Efficacy 
 
Sponsor:  
 
 
Boston Scientific Corporation 
25155 Rye Canyon Loop 
Valencia, CA 91355 
 
Device Information:   
Boston Scientific Neuromodulation 
Device Name:  
 
Versise Gevia™ or Genus™ DBS Systems 
Protocol Version: 
 
Protocol Version 4: 19 Feb 2024 
Principal Investigator:  
Nestor D. Tomycz, MD, FAANS 
Department of Neurosurgery 
AHN Allegheny General Hospital 
420 E North Avenue, Suite 302 
Pittsburgh, PA 15212 
Nestor.tomycz@ahn.org 
Phone: 412-359-6200 (24 Hours) 
 
Site Co-Investigator:  
Donald Whiting, M.D., M.S., F.A.C.S. 
Department of Neurosurgery 
AHN Allegheny General Hospital 
420 E North Avenue, Suite 302 
Pittsburgh, PA 15212 
Donald.Whiting@ahn.org 
 
 
 
 
Phone: Phone: 412-359-6200 (24 Hours) 
 
 
 

 
 
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Table of Contents 
Protocol Synopsis ............................................................................................................................. 5 
Abstract 
5 
Primary Objective 5 
Study Design: 
5 
Study Site: 5 
Study Population ............................................................................................................................. 6 
Recruitment Strategy 
6 
Subject Replacement 
6 
Inclusion Criteria 6 
Exclusion Criteria 6 
Subject Completion/Withdrawal 
7 
Description of Devices and Assessments .................................................................................... 7 
DBS System 
7 
UPRDS (United Parkinson’s Disease Rating Scale) 7 
Summary of Study Visits ............................................................................................................... 8 
Screening 8 
Visit One- Baseline (≤ 30 Days after Screening) 
8 
Figure 1. Visit 1 Assessment Schema 
9 
Randomization Procedure 10 
Visit Two (6 months +/- 30 Days) 10 
Visit Three (12 months +/- 30 days) 
10 
DBS Programming Procedure 
11 
Outcomes Being Measured .......................................................................................................... 12 
Adverse Events and Serious Adverse Events 
12 
Secondary Endpoints 
12 
Statistical Methods 12 
Regulatory and Ethical Considerations ................................................................................... 13 
Compliance Statement 
13 
Risk Assessment 13 
Potential Benefits of Participation 13 
Confidentiality 
13 
Data Safety Monitoring 
14 
Payment to Subjects 
14 

 
 
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Publication ...................................................................................................................................... 14 
References ....................................................................................................................................... 14 
Appendix A ..................................................................................................................................... 16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Abbreviations and Definitions of Terms 
 
ADE  
Adverse Device Effect 
AE 
 
Adverse Event 
DBS  
Deep Brain Stimulation 
IPG 
 
Implantable Pulse Generator 
SAE 
 
Serious Adverse Event 
UPDRS 
United Parkinson’s Disease Rating Scale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Burst-Type Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson’s Disease: A Pilot Study of Tolerability and Efficacy  
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Protocol Synopsis 
 
Abstract 
Deep brain stimulation (DBS) has become an evidence-based treatment for movement 
disorders such as Parkinson’s disease.  Recent animal studies of DBS suggest that neuronal 
subpopulations may be specifically activated by burst-type DBS and that this type of 
electrical stimulation programming may improve the efficacy and durability of DBS.  Burst-
type DBS is defined as a novel stimulation protocol in which intermittent bursts of 
traditional high-frequency rectangular wave stimulation are delivered.  Implanted pulse 
generators (IPGs) have the capability to deliver such stimulation by setting specific “on” and 
“off” times, however there is no published human data on the results of such programming 
in patients undergoing DBS for movement disorders such as PD.  
 
Primary Objective 
The primary objective is to determine change in the UPDRS-III motor score in the 
medication OFF state with burst-type DBS programming in the acute setting (after 30 
minutes) and then after 6 months and 12 months for patients with bilateral subthalamic 
nucleus DBS for Parkinson’s disease.   
 
Study Design:  
Randomized, double-blind cross-over study with N= 5 patients implanted with bilateral 
subthalamic nucleus DBS. 
 
Study Site: 
Allegheny General Hospital 
Neuroscience Institute 
420 E. North Avenue 
Pittsburgh, PA 15212 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Study Population 
 
Patients for this study (N= 5) should have bilateral STN-DBS (with Boston scientific Gevia 
or Genus technology) implanted for Parkinson’s disease.  The patients should be on stable 
DBS programming settings and stable medication regimens defined as no DBS 
programming changes or Parkinson’s disease medication changes over past 2 weeks.  The 
DBS implantation should have been performed by either Dr. Nestor D. Tomycz, MD or Dr. 
Donald M. Whiting, MD at Allegheny General Hospital and implantation surgery must have 
occurred a minimum of 6 months prior to the day of enrollment.   
 
Recruitment Strategy 
Subjects will be recruited from the DBS practice of investigator neurosurgeons Dr. Nestor 
D. Tomycz MD and Dr. Donald M. Whiting MD.  Patients will be identified by the 
neurosurgeons as well as by DBS nurse Cindy Angle RN and physician assistant Amanda 
Webb PA-C. 
Recruitment will stop when approximately 5 subjects are enrolled.  It is expected that 
approximately 15 subjects will be enrolled to produce 5 evaluable subjects.  
Subject Replacement 
In the event that consented subjects are unable to complete study procedures for any reason 
(e.g. unable to attend visits, adverse reaction to burst programming, or other concerns 
determined by primary investigator), subjects will be withdrawn from the study and primary 
investigator may screen and enroll replacement subjects(s) to ensure the number of 
completed subjects equals 5.    
 
Inclusion Criteria 
1. Adult patients (male and female) ages 18-85 
2. Bilateral DBS-STN (subthalamic nucleus) target for idiopathic Parkinson’s 
disease implanted minimum 6 months prior to the day of study enrollment 
3. Stable DBS programming settings and Parkinson’s disease medications defined 
as no changes to either within past 2 weeks 
4. Comfortable using DBS controller to turn off device prior to study visits 
5. Able to provide informed consent and complete follow-up visits 
 
Exclusion Criteria 
1. DBS technology other than Boston scientific Genus/Gevia 
2. Unable to complete follow-up visits 
3. DBS brain targets other than STN (subthalamic nucleus) 
4. Signs of progressive cognitive decline 
 

 
 
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Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care.  They 
may also be discontinued from the study at the discretion of the Investigator for lack of 
adherence to study treatment or visit schedules, AEs, or due to medical illness which 
complicates follow-up.  The Investigator or the Sponsor (if applicable) may also withdraw 
subjects who violate the study plan, or to protect the subject for reasons of safety or for 
administrative reasons.  It will be documented whether or not each subject completes the 
clinical study. If the Investigator becomes aware of any serious, related adverse events after 
the subject completes or withdraws from the study, they will be recorded in the source 
documents and on the CRF. 
The study duration per subject will be up to 365 days. 
Description of Devices and Assessments 
DBS System  
Boston Scientific Neuromodulation (BSN) Vercise™ System: A neurostimulation device 
consisting of an implantable pulse generator (IPG), integrated rechargeable battery, two 
DBS leads, two DBS extensions, Burr Hole Cover, surgical tools, GUIDE XT Software and 
external devices (programming system, remote control, and charging system).  The 
implanted pulse generator (IPG) for this study will be either the Gevia or Genus model. 
 
UPRDS (United Parkinson’s Disease Rating Scale) 
The UPDRS is an assessment that can be utilized to follow the progression of PD and is 
completed by interviewing the patient. The UPDRS was developed in 1987 by neurologists 
as a gold standard to determine response to medications and has been heavily utilized to 
standardize the response to DBS.  There are 4 sections of the test (I-IV), as follows: 
 
(I) Mentation, Behavior, and Mood; 
(II) Activities of Daily Living (ADL); 
(III) Motor Examination; 
(IV) Complications of Therapy. 
 
This study will utilize only the Motor Examination (Section III) for study visits. Section III 
contains 14 items to evaluate overall motor disability, including the classic symptoms of PD. 
The questions in this section assess speech, facial expression, tremor at rest (for face, hands, 
and feet), action or postural tremor of hands, rigidity, finger taps, hand movements, rapid 
alternating movements of hands, leg agility, arising from chair, posture, gait, postural 
stability, and body bradykinesia and hypokinesia. Each item is scored on a scale from 0 
(normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, 
including separate questions regarding symptoms present axially and in appendages, 
ranging from 0 to 108. 

 
 
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Summary of Study Visits 
 
Screening 
Patients will be approached for possible study participation during a routine, standard of 
care visit.   All interested patients will undergo screening to determine eligibility into the 
study. Screening will including the following: 
 
 
• Review and signing of informed consent document.  
• Demographics: Date of birth, Gender, Ethnicity, Handedness 
• Medical history: Surgical/Interventional Procedure History, Parkinson’s Disease 
History (presence of symptoms required for eligibility will be documented), presence 
and in some cases severity of selected symptoms of either PD or PD medications that 
can also occur as a side effect of STN DBS dopamine dysregulation syndrome 
(DDS);  
• Review of current Parkinson’s disease medications: Dosage/frequency (Start Date, 
Stop Date) 
• Review of concomitant medications 
 
 
Visit One- Baseline (≤ 30 Days after Screening) 
• Parkinson’s disease dopaminergic medications will be withdrawn overnight to 
establish medication-OFF state and DBS will be turned OFF overnight for 
establishing DBS-OFF state.  Examiner will establish a UPDRS-III baseline with 
medication-OFF, DBS-OFF state. 
• Unblinded examiner will then turn the DBS ON to the patient’s baseline DBS 
settings continuously ON or to burst DBS mode (baseline DBS settings for the 
patient with DBS set to 1 sec ON, 4 sec OFF), based on results of randomization.  
The patient will be blinded to this programming change and will be kept at this initial 
setting for 30 minutes. 
• Next, a blinded examiner who did not perform the programming change will perform 
a UPDRS-III evaluation.  Next, the DBS will be turned off for 15 minutes to permit 
for a washout period.   
• Next, the DBS will be turned on by the unblinded examiner to the alternate setting 
(burst DBS in case that the patient first was turned on with their baseline DBS setting 
or baseline DBS setting in case that the patient was first turned on with burst DBS 
setting) and kept on this setting for 30 minutes.   
• After 30 minutes, the blinded examiner will perform another UPDRS-III evaluation.  
Patients, who are blinded to the stimulation setting, will be asked if they preferred 
one stimulation mode over the other.  
• If any adverse events occur with burst DBS mode, the unblinded examiner will 
decrease the amplitude of the DBS by 0.5mA increments until the adverse events 
abate.  If there are not persistent adverse events with 30 minutes of burst DBS mode, 
the patient will be kept in burst DBS mode at the end of first visit and will be 
allowed to take their Parkinson’s disease medications. 

 
 
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Figure 1. Visit 1 Assessment Schema 
 
 
 
UPDRS III
(Meds OFF/DBS 
OFF)
Patient randomized 
to BURST or 
BASELINE DBS 
settings
Patient 
programmed to 
BURST setting. Wait 
30 minutes
UPDRS III
(Meds OFF/DBS 
ON)
DBS turned off for 
15 minute washout
Patient 
programmed to 
BASELINE setting. 
Wait 30 minutes
UPDRS III
(Meds OFF / DBS 
ON)
Patient 
programmed to 
BASELINE setting. 
Wait 30 minutes
UPDRS III
(Meds OFF/DBS 
ON)
DBS turned off for 
15 minute washout
Patient 
programmed to 
BURST setting. Wait 
30 minutes
UPDRS III
(Meds OFF / DBS 
ON)

 
 
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Randomization Procedure 
Subjects will be randomized to determine which DBS setting is initially programmed during 
visit one. All subjects will be programmed to both settings over the course of the visit, but 
the order is randomized to ensure appropriate blinding of the UPDRS assessor. Subjects 
have a 50% chance of being randomized to the “burst” mode, and a 50% chance of being 
randomized to the “baseline” mode. Following the initial UPDRS assessment (Meds 
OFF/DBS OFF), the study coordinator or unblinded assessor will used a computerized 
randomization system to determine which DBS setting the subject receives first.  
 
 
Visit Two (6 months +/- 30 Days) 
• Parkinson’s disease dopaminergic medications will be withdrawn overnight to 
establish medication-OFF state and DBS will be turned OFF overnight for 
establishing DBS-OFF state.   
• Examiner will establish a UPDRS-III baseline with medication-OFF, DBS-OFF 
state.  Examiner will then turn the DBS ON to the burst DBS state and keep ON for 
30 minutes. After 30 minutes the examiner will perform another UPDRS-III 
evaluation and will ask about any adverse effects.  Patients will then be allowed to 
take their Parkinson’s disease medications and will be kept on the burst mode DBS 
state.   
• Patients will be asked if they prefer the burst mode DBS state to their baseline 
settings before the study. 
 
Visit Three (12 months +/- 30 days) 
• Parkinson’s disease dopaminergic medications will be withdrawn overnight to 
establish medication-OFF state and DBS will be turned OFF overnight for 
establishing DBS-OFF state.   
• Examiner will establish a UPDRS-III baseline with medication-OFF, DBS-OFF 
state.  Examiner will then turn the DBS ON to the burst DBS state and keep ON for 
30 minutes. After 30 minutes the examiner will perform another UPDRS-III 
evaluation and will ask about any adverse effects.  Patients will then be allowed to 
take their Parkinson’s disease medications and will be kept on the burst mode DBS 
state.   
• Patients will be asked if they prefer the burst mode DBS state to their baseline 
settings before the study. At the conclusion of the study, patients will be asked if 
they want to continue to use burst DBS state or if would prefer to be programmed 
back to their pre-study baseline DBS settings. 
 
 
Phone Follow-Up Visits 
 
Phone follow up calls will be completed by study personnel to determine subject’s 
programming preference at 1 week, 1, 3 and 9 months post programming changes. 
 

 
 
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Table 1. Schedule of Study Events 
 
Activities 
Screening/ 
Enrollment 
Visit 1 
(Baseline) 
Visit 2 
Month 6 
+/- 30 days 
Visit 3 
Month 12 
+/- 30 days 
Phone 
Follow-up4 
Informed Consent  
x 
  
  
  
 
Demographics 
x 
 
 
 
 
Medical History 
x 
 
 
 
 
Parkinson's 
Medications 
x 
x 
x 
x 
x 
Concomitant 
medications 
x 
x 
x 
x 
x 
Adverse Events 
 
x 
x 
x 
x 
Serious Adverse 
Events 
 
x 
x 
x 
x 
Adverse Device 
Effects 
 
x 
x 
x 
 
UPDRS III (Meds 
OFF1/DBS OFF2) 
 
x 
x 
x 
 
UPDRS III (Meds 
OFF1/DBS ON- 
Burst) 
 
x 
x 
x 
 
UPDRS III (Meds 
OFF1/DBS ON- 
Baseline3) 
 
x 
 
 
 
 
1 Parkinson’s disease dopaminergic medications should be withdrawn overnight to establish 
medication-OFF state                                                                                                                                           
2 DBS should be turned off overnight to establish DBS-OFF state                                                                     
3 DBS should be programmed to the baseline settings patient had before study entry 
4 Phone follow up calls to determine subject’s programming preference will be completed by 
study personnel at 1 week, 1, 3 and 9 months post programming changes.     
                                                                                                  
 
DBS Programming Procedure 
Each time that programming is performed it will be conducted in the same manner as is 
done for DBS in movement disorders: each electrode will be systematically checked for 
impedance. The optimal electrodes will be used in either monopolar or bipolar mode to 
maximize the clinical benefit. At no time will charge densities above 30 microCouloumbs/ 
cm2 /phase be applied.  
 

 
 
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The parameters that may be are, the polarity of stimulation (off, negative, or positive), 
bipolar or monopolar stimulation, the amplitude (0-0.1 mA), the pulse width (10-450 msec), 
and the frequency of stimulation (2-225 Hz). Each programming session will be performed 
in the same manner: Beginning on the right side of the body, interrogate the stimulator with 
the Access Review device. Determine if the device has been on continuously since the last 
visit, and if there were any activations. The impedance of that device will then be measured 
(normal impedance 250–2,000 OHMs). In this protocol, subjects will be blinded to which 
electrodes will be active during each test period of stimulation. 
Outcomes Being Measured 
Adverse Events and Serious Adverse Events 
An adverse event (AE) is any undesirable experience (sign, symptom, illness, or other 
medical event) occurring in the patient, regardless if it is associated with the investigational 
procedure that appears or worsens during the clinical study. 
 
A serious adverse event (SAE) is one that:  
- Results in death  
- Is life-threatening  
- Requires inpatient hospitalization or prolongs hospitalization  
- Result in disability or permanent damage to the body’s function or structure  
- Results in a congenital anomaly or birth defect  
- Required intervention to prevent permanent impairment or damage  
- Or, is an important medical event - when the event does not fit the other outcomes, 
but may jeopardize the patient and may require medical or surgical intervention 
(treatment) to prevent one of the other outcomes.  
 
Adverse event information will be collected throughout the study, beginning once the patient 
is enrolled in the study and monitored until each event is adequately resolved or explained. 
An AE or SAE description (including the nature of the event, date and time of onset, 
determination of non-serious versus serious, intensity, duration, causality, and outcome of 
the event) will be recorded on the case report forms by the investigator or research 
coordinator. A summary report of all serious adverse events will be provided to the 
reviewing IRB annually. Serious adverse events will be reported within 5 days of the 
investigator learning of the event to the reviewing IRB. 
 
Secondary Endpoints 
Burst DBS may require less energy and therefore a secondary endpoint we will include is a 
calculation of IPG (implanted pulse generator) or battery longevity.  Secondary endpoints 
will also patient preference for stimulation mode.   
Statistical Methods 
Statistics will be performed using Mann-Whitney-U test and p-value < 0.05 will be required 
for statistical significance. 

 
 
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Regulatory and Ethical Considerations 
Compliance Statement 
This study will be conducted in full accordance all applicable Allegheny Health Network 
Research Policies and Procedures and all applicable Federal and state laws and regulations 
including 45 CFR 46, 21 CFR Parts 50, 54, 56, 312, 314 and 812 and the Good Clinical 
Practice: Consolidated Guideline approved by the International Conference on 
Harmonisation (ICH). All episodes of noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with the AHN IRB Policies IRB Policies and Procedures and all federal 
requirements. Collection, recording, and reporting of data will be accurate and will ensure 
the privacy, health, and welfare of research subjects during and after the study.  
Risk Assessment 
Risks of the study are minimal.  Patients may experience a temporary worsening of motor 
symptoms when they stop medications the night before patient visits and may also 
experience a temporary worsening of motor symptoms when programmed into burst-type 
DBS.  These motor symptom changes, if they do occur, would be reversible, and no patient 
will be required to continue using burst-type DBS after the first visit if they do not want to 
or if they find the motor symptom changes worse or bothersome.  Patients may contact a 
member of the study team if they wish to exit the study or stop using burst-type DBS 
programming at any time.   
Potential Benefits of Participation 
The potential benefits of burst-type DBS include the potential of better motor symptom 
control including improved tremor, improved rigidity, and improved dyskinesias.  An 
additional benefit may be that burst-type DBS may require lower energy for treatment and 
could therefore prolong DBS implanted pulse generator (IPG) life.   
Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy and that the Investigator and other site 
personnel will not use such data and records for any purpose other than conducting the 
study. All patient data will be de-identified and kept on a secure computer within the 
Neuroscience Research Department at Allegheny General Hospital.  
 
No identifiable data will be used for future study without first obtaining IRB approval. The 
investigator will obtain a data use agreement between the provider (the PI) of the data and 

 
 
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any recipient researchers (including others at AHN) before sharing a limited dataset (PHI 
limited to dates and zip codes).  
 
Data Safety Monitoring 
The research team, including the PI, will meet a minimum of every 12 months to review 
accruals, adverse events, potential breaches in confidentiality and any unanticipated 
problems related to this research.  Any identified reportable events or breaches in 
confidentiality will be reported immediately to AHNRI IRB and AHN Privacy Department. 
Any events or changes in the risk/benefit ratio affecting decisions about study continuation 
will be submitted to the IRB immediately via a prompt report form. 
Payment to Subjects 
Study subjects will receive $50.00 US dollars stipend for their time/inconvenience for each 
completed visit for a possible total of $150.00 US dollars if all 3 visits are completed. 
Subjects will be provided with a debit card which will be used to deposit each stipend 
amount at the end of each visit.  
 
Publication 
Data analysis will occur for 3 months after study completion with a plan to publish the data 
in a peer-reviewed neurological journal.   
 
References 
Brocker, D.T., Swan, B.D., Turner, D.A., Gross, R.E., Tatter, S.B., Miller Koop, M., 
Bronte-Stewart, H., Grill, W.M., Koop, M.M., Bronte-Stewart, H., et al. (2013). 
Improved efficacy of temporally non-regular deep brain stimulation in Parkinson’s 
disease. Exp. Neurol. 239, 60-67 
Eisinger, Robert S., et al. “A review of basal ganglis circuits and physiology: application to 
deep brain stimulation.”   Parkinsonism & related disorders 59 (2019): 9-20. 
Grill, W.M. (2018). Temporal Pattern of Electrical Stimulation is a New Dimension of 
Therapeutic Innovation. Curr. Opin. Biomed. Eng. 8, 1–6. 
Mastro, K.J., Zitelli, K.T., Willard, A.M., Leblanc, K.H., Kravitz, A. V., and Gittis, A.H. 
(2017). Cell-specific pallidal intervention induces long-lasting motor recovery in 
dopamine-depleted mice. Nat. Neurosci. 20, 815–823. 
Spix, T. A., Nanivadekar, S., Toong, N., Kaplow, I. M., Isett, B. R., Goksen, Y., ... & Gittis, 
A. H. (2021). Population-specific neuromodulation prolongs therapeutic benefits of 
deep brain stimulation. Science, 374(6564), 201-206. 
 
 

 
 
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Appendix A 
 
Visit 1 Case Report Form 
 
 
Subject # __________________ 
 
 
 
 
Date ________ / ________ / ________ 
              dd            mmm           yyyy  
 
 
Last dose of Parkinson’s medications: ___________ am / pm  
 
Time DBS device turned off: __________ am / pm 
 
 
To be completed by unblinded examiner 
 
 
Subject randomization for initial DBS setting (Circle):      Burst       /       Baseline 
 
 
 
   Left                      Right 
 
Active Contacts 
_______ 
_______ 
 
Amplitude 
_______ 
_______ 
 
Pulse Width 
_______ 
_______ 
 
Frequency 
_______ 
_______ 
 
 
 
Subject Programming Preference (Circle):      Burst       /      Baseline      /      No preference  
 
    
Comments: 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________ 
 

 
 
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Appendix A 
 
Visit 2 and 3 Case Report Form 
 
 
Subject # __________________ 
 
 
 
 
Date ________ / ________ / ________ 
              dd            mmm           yyyy  
 
 
Last dose of Parkinson’s medications: ___________ am / pm  
 
Time DBS device turned off: __________ am / pm 
 
 
 
 
 
   Left                      Right 
 
Active Contacts 
_______ 
_______ 
 
Amplitude 
_______ 
_______ 
 
Pulse Width 
_______ 
_______ 
 
Frequency 
_______ 
_______ 
 
 
 
 
 
    
Comments: 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________