LFP Beta aDBS Feasibility Study

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