Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease (Aim 2)

Inclusion Criteria:

• Signed informed consent

• Diagnosis of Idiopathic Parkinson's disease (PD) with motor symptoms present for aminimum of 4 years

• Severe motor symptoms (e.g., motor fluctuations, dyskinesia, tremor, bradykinesia,rigidity) despite optimized medical therapy, that warrant surgical implantation ofdeep brain stimulation (DBS), according to standard clinical criteria

• Unified Parkinson's Disease Rating Scale (UPDRS-III) score off medication 20 to 80,and improvement of at least 30% in UPDRS-III score on medications, ortremor-dominant PD (score >/= 2 on UPDRS-III tremor sub-score) or tremor in additionto other motor symptoms that are treatment-resistant and result in significantfunctional disability

• Appropriate trials of oral PD medications resulting in inadequate relief of motorsymptoms as determined by a movement disorders neurologist, and stable dose ofanti-PD medications for 30 days prior to study enrollment

• Requested and approved for subthalamic nucleus deep brain stimulation surgery (STNDBS) by study site Multi-Disciplinary Movement Disorders Patient Care Conference

• Absence of abnormalities on brain magnetic resonance imaging (MRI) scan suggestiveof an alternate diagnosis or serving as a contraindication to surgery

• Absence of significant cognitive deficits or significant depression (Beck DepressionInventory-II, BDI-II, score > 20) on formal Neuropsychological Testing

• Age 18 to 80 years (19 to 80 years in Nebraska)

• Able to conduct follow up neurological care exclusively at study site for durationof the RC+S INS neurostimulator device lifespan (9 years)

Exclusion Criteria:

• Any medical condition considered to elevate risk for surgical complications, such ascoagulopathy,, uncontrolled hypertension, history of seizures, heart disease,inability to undergo general anesthesia, or anticoagulant medications that cannot besafely discontinued for perioperative period

• Pregnancy (women of child-bearing potential must have a negative urine pregnancytest prior to surgical procedures)

• Significant untreated depression (Beck Depression Inventory-II, BDI-II > 20 orGeriatric Depression Scale, GDS, score > 8)

• Personality or mood disorder symptoms that investigators believe will interfere withstudy requirements

• Required ongoing treatment with electroconvulsive therapy (ECT), repetitivetranscranial magnetic stimulation (rTMS), or diathermy

• Pre-existing implanted stimulation system (e.g., cochlear implant, cardiacpacemaker, defibrillator, neuro-stimulator for indication other than Parkinson'sdisease), or ferromagnetic metallic implant

• Prior intracranial surgery

• History or active, drug or alcohol abuse

• Meets criteria for Parkinson's disease (PD) with Mild Cognitive Impairment (PD-MCI),as defined by Performance > 2 standard deviations below appropriate norms on testsfrom 2 or more of the following cognitive domains: Attention, Executive Function,Language, Memory, and Visuospatial Ability

• Restless Leg Syndrome

• Obstructive Sleep Apnea

• Inability to perform the recharge process necessary to use the RC+S brainstimulation system