Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease

Trial ID or NCT#



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Parkinson's disease (PD) is a neurodegenerative disorder that leads to both motor and non-motor symptoms. Therapies have been developed that effectively target the motor symptoms. Non-motor symptoms are far more disabling for patients, precede the onset of motor symptoms by a decade, are more insidious in onset, have been less apparent to clinicians, and are less effectively treated. Sleep dysfunction is oftentimes the most burdensome of the non-motor symptoms. There are limited options for treating sleep dysfunction in PD, and the mainstay of therapy is the use of sedative-hypnotic drugs without addressing the underlying mechanisms. Patients with PD who demonstrate significant motor fluctuations and dyskinesia are considered for subthalamic nucleus (STN) deep brain stimulation (DBS) surgery. Several studies have reported that STN-DBS also provides benefit for sleep dysregulation. Additionally, local field potentials recorded from STN DBS electrodes implanted for the treatment of PD, have led to the identification of unique patterns in STN oscillatory activity that correlate with distinct sleep cycles, offering insight into sleep dysregulation. This proposal will leverage novel investigational DBS battery technology (RC+S Summit System; Medtronic) that allows the exploration of sleep biomarkers and prototyping of closed-loop stimulation algorithms, to test the hypothesis that STN contributes to the regulation and disruption of human sleep behavior and can be manipulated for therapeutic advantage. Specifically, in PD patients undergoing STN-DBS, the investigators will determine whether STN oscillations correlate with sleep stage transitions, then construct and evaluate sensing and adaptive stimulation paradigms that allow ongoing sleep-stage identification, and induce through adaptive stimulation an increase in duration of sleep stages associated with restorative sleep.

Official Title

Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease: An Investigation of STN LFP Biomarkers in Sleep Dysregulation and Repair

Eligibility Criteria

Ages Eligible for Study: 21 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Ability to provide informed consent for this study - Diagnosis of Idiopathic Parkinson's disease with motor symptoms that have been present for a minimum of 4 years - Motor symptoms are severe enough, despite optimized medical therapy, to warrant surgical implantation of DBS - UPDRS-III score off medication between 20 and 80, and an improvement in UPDRS-III score on medications of at least 30%, or patients with tremor-dominant PD (score >/= 2 on UPDRS-III tremor sub-score)-or tremor in addition to other motor symptoms-that is treatment-resistant and results in significant functional disability - Appropriate trials of oral PD medications have resulted in inadequate relief of motor symptoms - Absence of abnormalities on brain MRI suggestive of an alternate diagnosis or serving as a contraindication to surgery - Absence of significant cognitive deficits or significant depression (BDI-II score > 20) on formal Neuropsychological Testing - Age 21 - 80 years
Exclusion Criteria:
  1. - Coagulopathy, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia - Pregnancy - Significant untreated depression (BDI-II score > 20) - Personality or mood disorder symptoms that Study Personnel believe will interfere with study requirements - Patients requiring ongoing treatment with ECT, rTMS, or diathermy - Pre-existing implanted stimulation system (e.g., cochlear implant, cardiac pacemaker, defibrillator, neuro-stimulator for indication other than Parkinson's disease) or ferromagnetic metallic implant - Prior intracranial surgery - History of, or active, drug or alcohol abuse - Meets criteria for PD with Mild Cognitive Impairment (PD-MCI), as defined by Performance > 2 standard deviations below appropriate norms on tests from 2 or more of the following cognitive domains: Attention, Executive Function, Language, Memory, and Visuospatial Ability - Patients with Restless Leg Syndrome


Clete A. Kushida, MD, PhD
Clete A. Kushida, MD, PhD
Sleep specialist, Neurologist
Professor of Psychiatry and Behavioral Sciences (Sleep Medicine)