MEDTRONIC BRAINSENSE™ TECHNOLOGY:*

CLINICIAN CASE STUDY ON UNCOVERING

SUBOPTIMAL PROGRAMMING
Data presented represents the experience, results, and recommendations of one clinician’s use
with the Percept™ PC device. Results in other case studies may vary.

“The LFP data retrieved from BrainSense™ helped me quickly uncover that the patient was overstimulated on the right hemisphere.
I used Event LFP Captures and Live Streaming to inform my therapy decisions. These features of BrainSense™ technology allowed
me to achieve optimal programming for the patient in just 3 visits. As a result, the therapy is improving the patient’s symptoms
more efficiently and offers treatment optimization for a better quality of life.”
– Dr. Okeanis Vaou

Patient Background Snapshot

 A 66-year-old man diagnosed with Parkinson’s disease due for a neurostimulator replacement.
 Patient had limited mobility due to Parkinson’s disease and was sub-optimally controlled at his prior DBS Therapy settings.
The patient was wheelchair-bound and suffered from rigidity, dyskinesia, and severe motor fluctuations throughout the day.
 The patient and family decided to move forward with the decision to replace with Percept PC, with BrainSense™ technology.

Clinician and Patient Goals Left Hemisphere Right Hemisphere

 Gain objective data and insights about the patient’s disease state and
current fluctuations.
 Optimize therapy by helping to reduce rigidity, dyskinesia, and severe
motor fluctuations throughout the day.
 Figure 1 shows initial patient therapy configurations after replacement,
with interleaving on right hemisphere.
Figure 1
Initial BrainSense™ SetUp
In the PACU, post implant. BrainSense™ Survey & New Therapy Group Set up.
Observations:
 BrainSense™ Survey was conducted to identify peaks. A peak of 0.54uVp at 36.13 Hz was identified and confirmed in
BrainSense™ Set UP for chronic sensing (Figure 2). BrainSense™ Survey helped to identify local field potential (LFP) peaks that
may be good signals of interest for tracking in BrainSense™ Streaming when adjusting medication or stimulation therapy.
 BrainSense™ Survey identified a clear Gamma Peak 0.59uVp at 68.36 Hz which correlates the underlying disease state
symptoms of dyskinesia (Figure 2).

Figure 2
*The sensing feature of the Percept™ PC system is intended for use in patients receiving DBS where chronically-
recorded bioelectric data may provide useful, objective information regarding patient clinical status. Signal may
not be present or measurable in all patients. Clinical benefits of brain sensing have not been established.
All data for this case study was provided by Dr. Okeanis Vaou under a Data Access Agreement. The information
presented is from a single patient.
UC202204923aEN
Actions taken: Left Hemisphere Right Hemisphere

 Created Group B (labeled: BrainSense group) where

™

interleaving was removed so that left and right

hemispheres would be conducive to sensing. Group A was
still accessible to patient if they needed to revert to their
original therapy (Figure 3).
 BrainSense™ Events (LFP Snapshots) were set up for
“Dyskinesia” and “OFF Time” and the caregivers could
record the future events.

First Programming Session

2 weeks after initial BrainSense™ SetUp.
BrainSense™ Timeline and BrainSense™ Events used to
observe symptoms and modify therapy. Figure 3: Group A with original therapy settings and
Group B with BrainSense™ compatible settings and
Patient input: interleaving removed.
 Patient complained of rigidity & severe dyskinesia and was
utilizing the programmer to track these most bothersome
symptoms.
 Tried multiple times to go back to Group A (original therapy
settings) but felt increased dyskinesia and rigidity on this
setting.
 Attempt to change in Groups on 7/15 and 7/16 is noted in
green on Timeline (Figure 4).
Clinician observations and Actions:
 The BrainSense™ Timeline view showed high frequency
band fluctuations in the left and right STN (Figure 4).
 Stimulation adjustments were made to the right STN by
changing original settings of 3.9 mA and 60 us to 3.0 mA
and 30 us Left STN also had a decrease in pulse width from
60 us to 30 us (Figure 5).
 New BrainSense™ Event of “Medication” was added to Figure 4
existing Events, “Dyskinesia” and “OFF Time”, to look for
any correlations between medication, frequency band
levels, and symptomatic state.

Second Programming Session

2 weeks post first programming session.
Streaming revealed key information.
Patient input:
The patient and caregivers noted an improvement in Figure 5
overall mobility with decreased severity and frequency of
dyskinesias since adjustments made at previous visit. The
patient’s main complaint was still experiencing some rigidity,
especially in right side of the body.
Observations and Actions:
When looking at Event Snapshots, some of the programming
changes made at first visit seemed to decrease peak power
during “Medications,” “OFF time,” and “Dyskinesias”;
therefore, therapy programming was in a better direction, but
still could be further optimized.
A decision was made to live-stream using BrainSense™
Streaming, with the beta frequency of interest at 10.74 Hz
to assess stimulation relationship to peak power correlating
Figure 6
with symptoms of rigidity (Figure 6).
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All data for this case study was provided by Dr. Okeanis Vaou under a Data Access Agreement. The information presented is from a single patient.
 While live-streaming and decreasing stimulation amplitude, clinician observed a decrease in bradykinesia as the patient
performed the task of hand open-close and an increase in shoulder rigidity /tightness. In addition, secondary observations of
improvement were made in the patient’s dysarthria and dyskinesia.
 The patient’s improvement in symptoms was noted while live streaming, showing suppression in the tracked frequency of
10.74 Hz, corresponding to the patient’s main complaint of rigidity.
Key Finding:
Review of BrainSense™ Streaming provided objective data which helped the clinician conclude that the patient was experiencing
stimulation-induced corticospinal effects due to over-stimulation. The patient had been interpreting these as symptoms of PD,
and had been increasing stimulation within physician prescribed limits to try to manage the symptoms with no improvement.

Third Programming Session

1 week after second programming session.
Key observations after programming to a lower amplitude.
Physician Observations:
The patient had noticeable improvement in mobility as he was no longer wheelchair-bound and able to walk unassisted. The
patient shared that he was able to walk a mile a day, and was able to return to an engaged lifestyle. The patient experienced
decreased bradykinesia, and improved dyskinesias.
Medtronic’s DBS therapy safely and effectively manages tremor, rigidity, and bradykinesia associated with Parkinson’s disease.
DBS improves quality of life and activities of daily living for Parkinson’s patients. It may be a therapeutic option for patients with
recent or longer-standing motor complications.
Decrease in beta and gamma peak power in LFP Captured Events (Figures 7 and 8):
Reduction in µVp peak amplitude during events
Off Time Events Dyskinesia Events Medication Events
Left STN No reduction 69% 33%
Right STN 44% 71% 45%
Figure 7 illustrates how using BrainSense can confirm the presence of gamma activity with the dyskinesias. It further supports the improvement with the
programming changes.
Baseline Event LFP Capture Dyskinesia 7.14.20 Event LFP Capture Dyskinesia 8.10.20 Visit

69% reduction in uVp

71% reduction in uVp

Figure 8
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All data for this case study was provided by Dr. Okeanis Vaou under a Data Access Agreement. The information presented is from a single patient.
 Summary of purpose and use of each BrainSense™ feature

BRAINSENSE™ SETUP
In order to use all features of BrainSense™ technology (with the exception of BrainSense™ Survey), the user must first setup LFP sensing
using BrainSense™ Setup, and select a frequency band of interest (approximately 5Hz wide) to track while the patient is out of office.
Use: In-clinic, with approximately 90 seconds measurement for setup.

BRAINSENSE™ SURVEY
Broad spatial overview of LFP signals measurable from both hemispheres of the patient with stimulation off.
Use: In-clinic, with approximately 90 second measurement duration.

BRAINSENSE™ TIMELINE
Once BrainSense™ Setup has been completed, the Timeline can be used to analyze the out of-office data when the patient returns to the
clinic. This is used to assess the data for changes in LFP activity that may occur over the course of a day(s).
Use: Outside-clinic

BRAINSENSE™ EVENTS
Once BrainSense™ Setup has been completed, BrainSense™ Events, a.k.a LFP Snapshots, can be recorded at a moment in time, showing the
magnitude of the LFP signal over a range of frequencies. The LFP Snapshot is recorded when the patient records an event (eg, ‘symptom’ or
‘medication intake’) as configured by the clinician. This is used to assess the occurrence of clinician-defined events, and associated LFP activity
with those events.
Use: Outside-clinic, the snapshot is representative of a period of approximately 30 sec after patient marking an event.

BRAINSENSE™ STREAMING
Once BrainSense™ Setup has been completed, the user can view the LFP power in a selected frequency band in real-time, by streaming
the data to the clinician tablet. This is used to observe changes in the LFP during active stimulation programming or while instructing
and observing the patient performing activities. Moreover, Streaming can be used to collect time domain data from the selected
channel(s) for offline analysis and signal processing.
Use: In-clinic, with no limit on streaming measurement duration, with or without stimulation.

Brief Statement: Medtronic DBS Therapy for Parkinson’s Disease and Tremor

Medtronic DBS Therapy for Parkinson’s Disease and Tremor: Product labeling must be reviewed prior to use for detailed
disclosure of risks.

INDICATIONS:
Medtronic DBS Therapy for Parkinson’s Disease: Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic
nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of
the symptoms in individuals with levodopa-responsive Parkinson's disease of at least 4 years’ duration that are not adequately
controlled with medication, including motor complications of recent onset (from 4 months to 3 years) or motor complications
of longer-standing duration.

Medtronic DBS Therapy for Tremor: Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic
DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for use in
patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where
the tremor constitutes a significant functional disability.

CONTRAINDICATIONS: Medtronic DBS Therapy is contraindicated (not allowed) for patients who are unable to properly
operate the neurostimulator and patients for whom test stimulation is unsuccessful. The following procedures are
contraindicated for patients with DBS systems: diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic
ultrasound diathermy), which can cause neurostimulation system or tissue damage and can result in severe injury or death;
Transcranial Magnetic Stimulation (TMS); and certain MRI procedures using a full body transmit radio-frequency (RF) coil, a
receive-only head coil, or a head transmit coil that extends over the chest area if the patient has an implanted Soletra™ Model
7426 Neurostimulator, Kinetra™ Model 7428 Neurostimulator, Activa™ SC Model 37602 Neurostimulator, or Model 64001 or
64002 pocket adaptor.

WARNINGS: There is a potential risk of brain tissue damage using stimulation parameter settings of high amplitudes and
wide pulse widths and a potential risk to drive tremor (cause tremor to occur at the same frequency as the programmed
frequency) using low frequency settings. Extreme care should be used with lead implantation in patients with an increased
risk of intracranial hemorrhage. Sources of electromagnetic interference (EMI) may cause device damage or patient injury.
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All data for this case study was provided by Dr. Okeanis Vaou under a Data Access Agreement. The information presented is from a single patient.
Theft detectors and security screening devices may cause stimulation to switch ON or OFF and may cause some patients to
experience a momentary increase in perceived stimulation. The DBS System may be affected by or adversely affect medical
equipment such as cardiac pacemakers or therapies, cardioverter/ defibrillators, external defibrillators, ultrasonic equipment,
electrocautery, or radiation therapy. MRI conditions that may cause excessive heating at the lead electrodes which can result in
serious and permanent injury including coma, paralysis, or death, or that may cause device damage, include: neurostimulator
implant location other than pectoral and abdominal regions; unapproved MRI parameters; partial system explants (“abandoned
systems”); misidentification of neurostimulator model numbers; and broken conductor wires (in the lead, extension or pocket
adaptor). The safety of electroconvulsive therapy (ECT) in patients receiving DBS Therapy has not been established. Abrupt
cessation of stimulation should be avoided as it may cause a return of disease symptoms, in some cases with intensity greater
than was experienced prior to system implant (“rebound” effect). New onset or worsening depression, suicidal ideations,
suicide attempts, and suicide have been reported.

Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system.
Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or
dislodgement that may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional
surgery to replace or reposition the component. Patients should avoid manipulating the implanted system components or burr
hole site as this can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Patients
should not dive below 10 meters (33 feet) of water or enter hyperbaric chambers above 2.0 atmospheres absolute (ATA) as this
could damage the neurostimulation system, before diving or using a hyperbaric chamber, patients should discuss the effects of
high pressure with their clinician. Patients using a rechargeable neurostimulator must not place the recharger over a medical
device with which it is not compatible (eg, other neurostimulators, pacemaker, defibrillator, insulin pump). The recharger could
accidentally change the operation of the medical device, which could result in a medical emergency. Patients should not use the
recharger on an unhealed wound as the recharger system is not sterile and contact with the wound may cause an infection.

PRECAUTIONS: Loss of coordination in activities such as swimming may occur. Patients using a rechargeable neurostimulator
for Parkinson’s disease or essential tremor should check for skin irritation or redness near the neurostimulator during or after
recharging, and contact their physician if symptoms persist.

ADVERSE EVENTS: Adverse events related to the therapy, device, or procedure can include intracranial hemorrhage,
cerebral infarction, CSF leak, pneumocephalus, seizures, surgical site complications (including pain, infection, dehiscence,
erosion, seroma, and hematoma), meningitis, encephalitis, brain abscess, cerebral edema, aseptic cyst formation, device
complications (including lead fracture and device migration) that may require revision or explant, extension fibrosis (tightening
or bowstringing), new or exacerbation of neurological symptoms (including vision disorders, speech and swallowing disorders,
motor coordination and balance disorders, sensory disturbances, cognitive impairment, and sleep disorders), psychiatric and
behavioral disorders (including psychosis and abnormal thinking), cough, shocking or jolting sensation, ineffective therapy and
weight gain or loss.

Safety and effectiveness has not been established for patients with neurological disease other than idiopathic Parkinson’s
disease or Essential Tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe
depression, patients who are pregnant, or patients under 18 years. Safety and effectiveness of Medtronic DBS Therapy for
Tremor has not been established for bilateral stimulation or for patients over 80 years of age.

USA Rx only Rev 03/20

All data for this case study was provided by Dr. Okeanis Vaou under a Data Access Agreement. The information presented is from a single patient.

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