LFP Beta aDBS Feasibility Study

Inclusion Criteria:

Preoperative:

1. Subject has the ability to understand and provide written informed consent for
participation in the study prior to the study-related procedures being conducted

2. Subject with levodopa-responsive PD of at least 4 years' duration, with symptoms not
adequately controlled with medication, including individuals with motor complications
of recent onset (from 4 months to 3 years) or with motor complications of
longer-standing duration, and who are eligible for bilateral STN DBS surgery

3. Subject is ≥ 22 years of age at time of informed consent

4. Subject is a male or non-pregnant female. If female of child-bearing potential, and if
sexually active, must be using, or agree to use, a medically-acceptable method of
birth control as confirmed by the investigator

5. Subject has documented improvement in motor signs ON versus OFF dopaminergic
medication, with a change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III
score of > 30% OFF to ON medication

6. Based on the opinion of the Neurosurgeon, the subject is an acceptable candidate for
implant of a DBS System that includes: bilateral DBS leads targeted to the STN,
extensions, and neurostimulator

7. Subject can read and understand English

8. Subject is willing and able to attend all study-required visits and complete the study
procedures

9. Subject is willing and able to be awake during left and right DBS lead implant surgery
and for intraoperative LFP recordings

Intraoperative:

10. Required beta band (13 - 30 Hz) signal detected on left and right DBS leads

Exclusion Criteria

1. Subject has tremor dominant PD ≥ 2 at rest in head, upper, or lower extremities as
measured on the UPDRS Part III Question 20

2. Subject requires diathermy, transcranial magnetic stimulation (TMS), or
electroconvulsive therapy (ECT)

3. Subject has a history of prior intracranial surgery (eg, DBS, lesioning, previous
surgical ablation)

4. Subject is unable to undergo Magnetic Resonance Imaging (MRI) of the head for planning
the surgical DBS lead implants

5. Based on the opinion of the Neurosurgeon, the subject has a clinically significant
structural abnormality(ies) of the brain that would jeopardize subject safety during
the DBS lead implant, conduct of the study, or confound the subject's assessments

6. Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)

7. Subject has a major comorbidity increasing the risk of surgery (eg, prior stroke,
severe diabetes, severe hypertension, immunocompromised, seizure disorder, active
infection, need for chronic anticoagulation other than aspirin)

8. Subject has a neurocognitive impairment which exceeds the criteria for PD mild
cognitive impairment (PD-MCI) as determined from the center's clinical
neuropsychological evaluation prior to DBS for PD

9. Subject has, or plans to obtain, an implanted electrical stimulation medical device
anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator)

10. Subject has, or plans to obtain, an implanted medication pump (eg, DUOPATM infusion
pump) and/or portable infusion pump

11. Based on the opinion of the investigator, the subject has an abnormal neurological
examination that would preclude them from study participation

12. Subject is breast feeding

13. Subject has Mattis Dementia Rating Scale-2 (DRS-2) score ≤ 130

14. Subject has Beck Depression Inventory II (BDI-II) > 25

15. Subject is currently participating, or plans to participate, in another
investigational study unless written approval is provided by the Medtronic study team