Adaptive Deep Brain Stimulation (aDBS) Study (Early Adapter) Part II

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

Inclusion criteria

• Subject has Parkinson's disease with motor impairments.
• Subject is implanted with Percept PC and Medtronic DBS leads and extensions bilaterally in the same target (physician confirmed), STN or GPi.
• Subject has completed Early Adapter 1 study OR if the subject has not completed Early Adapter 1, she/he has documented evidence that aDBS is well tolerated in at least one mode (single or dual threshold) (Note: Tolerance means that the investigator has determined that aDBS is suitable for PD treatment). For subject who only tolerated dual threshold mode, aDBS must be set up in both hemispheres.
• Subject has Beta band (8-30 Hz) amplitude ≥ 1.2 μVp detected on either left and/or right DBS leads on sensing channels 0-2, 0-3, or 1-3; 8-10, 8-11, or 9-11; As assessed in screening from Early Adapter I study. For subjects who have not completed Early Adapter Part I, it can be assessed using the record of standard test of eligibility for aDBS at the site.
• The subject responds to DBS Therapy.
• The subject's cDBS parameters and PD medications are stable and expected to remain stable from enrollment through the end of the aDBS treatment phase. (Note: Stability is defined as no major changes in cDBS parameter and medication for the last 30 days prior to aDBS setup or as defined by the physician.)
• Subject is configured to monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side
• Subject is willing and able to attend all study-required visits and complete the study procedures.
• Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted.
• Subject is a male or non-pregnant female. If female of childbearing potential, and if sexually active, must be using, or agree to use, a medically acceptable method of birth control as confirmed by the investigator.

Exclusion criteria

• Subject and/or caregiver is unable to utilize the patient programmer.
• Subject has more than one lead in each hemisphere of the brain.
• Subject has cortical leads or additional unapproved hardware implanted in the brain.
• Subject has more than one INS.
• No tested mode of aDBS (single or dual threshold) is tolerated. (Note: Tolerance is defined that investigator has determined that aDBS is suitable for PD treatment.).
• At enrollment, the subject's INS has a predicted battery life of <1 year.
• Subject has untreated severe depression which may preclude them from study participation.
• Subject requires diathermy, transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or Magnetic resonance-guided focused ultrasound (MRgFUS).
• Subject has a metallic implant in the head, (e.g., aneurysm clip, cochlear implant).
• Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemaker, defibrillator, spinal cord stimulator).
• Subject has, or plans to obtain, an implanted medication pump for the treatment of Parkinson's disease (e.g., CADD-Legacy1400 pump) and/or portable infusion pump.
• The subject has an abnormal neurological examination that would preclude him from study participation.
• Subject is breast feeding.
• Subject is under the age of 20 years.
• 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.
• Subjects with signal artifact on all 6 aDBS sense pathways (3 on each of both DBS leads) which preclude the clinician from setting thresholds* *As assessed in aDBS setup from Early Adapter Part I and aDBS data