Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD)

The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.

Prospective single-blind, randomized crossover, multi-center study of aDBS in subjects with Parkinson's disease.

Inclusion Criteria:

General

1. Subject has idiopathic Parkinson's disease
2. Subject is implanted with Percept PC (Model B35200) and Medtronic Deep Brain Stimulation (DBS) leads (Model 3387, 3389, B33005 or B33015) and extensions (Model 37085, 37086, or B34000) bilaterally in the same target (physician confirmed), subthalamic nucleus (STN) or Globus Pallidus (GPi)
3. In the opinion of the investigator, the subject responds to DBS Therapy.
4. Based on the opinion of the investigator, the subject's cDBS parameters and PD medications are stable and expected to remain stable from enrollment through the end of the aDBS Evaluation phase
5. (Primary Cohort) Subject is configured to ring mode monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side.

5. (Directional Stimulation Cohort) Subject is configured to directional monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) 6. Subject is willing and able to attend all study-required visits and complete the study procedures (e.g. 1-month recall questionnaires, MDS-UPDRS III) 7. Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted 8. 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 9. For subjects with the SenSight system: Subject is configured to the following stimulation rates: 55, 85, 110, 125, 145, 164 or 180 Hz (as required for sensing/aDBS)

Local Field Potential (LFP) Screening Inclusion Criteria

1. Subject has required Alpha-Beta band (8-30 Hz) amplitude ≥ 1.2 µVp detected on either left and/or right DBS leads

Exclusion Criteria:

1. Subject and/or caregiver is unable to utilize the patient programmer
2. Subject has more than one lead in each hemisphere of the brain
3. Subject has cortical leads or additional unapproved hardware implanted in the brain
4. Subject has more than one INS
5. At enrollment, the subject's INS has a predicted battery life of <1 year
6. Subject has Beck Depression Inventory II (BDI-II) > 25
7. Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
8. Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)
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 for the treatment of Parkinson's disease (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 is under the age of 18 years
14. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by the Medtronic study team
15. Subject is unable to use or tolerate wearable
16. Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both DBS leads) which preclude the clinician from setting thresholds