Parkinson's Disease Clinical Trial
Official title:
Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease: An Investigation of STN LFP Biomarkers in Sleep Dysregulation and Repair
This study is aimed at testing the hypothesis that adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Investigators will directly test the efficacy of an adaptive stimulation protocol. Study subjects are adults with Parkinson's disease who experience inadequate motor symptom relief, and who have been offered implantation of a deep brain stimulator system targeting STN for the treatment of motor symptoms (standard-of-care). Investigators will implant 20 (n = 10 per clinical site) Parkinson's Disease subjects with the Medtronic RC+S System, enabling the implementation of real-time adaptive stimulation during in-home sleep. Prior to surgery, study subjects will complete clinical sleep questionnaires in an outpatient setting and wear an actigraphy watch for 3 weeks to monitor sleep architecture and sleep fragmentation. Three months after subjects have completed their standard-of-care Deep Brain Stimulation surgery and are optimized in terms of Parkinson's medication and clinical DBS stimulation parameters, we will monitor sleep for an additional 3 weeks, using in-home monitoring. During each week of the in-home monitoring period, subjects will undergo, in a randomized and double-blind fashion, one of three nocturnal stimulation algorithms: Adaptive stimulation, Open-Loop stimulation (standard clinical stimulation therapy) and No stimulation (control). During the 3 weeks of in-home sleep monitoring, we will monitor sleep architecture and sleep fragmentation using an actigraphy watch and subjects will complete a sleep questionnaire. At the end of the 3-week period of sleep-time randomized, blinded stimulation delivery, subjects will return to their standard stimulation therapy.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility | Inclusion Criteria: - Ability to provide informed consent for this study. - Signed informed consent. - Diagnosis of Idiopathic Parkinsons disease with motor symptoms that have been present for a minimum of 4 years. - Motor symptoms (e.g., motor fluctuations, dyskinesia, tremor, bradykinesia, rigidity) that are severe enough, despite optimized medical therapy, to warrant surgical implantation of DBS, according to standard clinical criteria. - 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 are treatment-resistant and result in significant functional disability. - Appropriate trials of oral PD medications have resulted in inadequate relief of motor symptoms as determined by a movement disorders neurologist, and anti-PD medications have been at stable doses for 30 days prior to study enrollment. - Patient has requested DBS surgery, and has been approved by the site (UNMC or University of Pennsylvania) Multi-Disciplinary Movement Disorders Patient Care Conference for STN DBS - 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 18 to 80 years (19 years for Nebraska) - Ability to conduct follow up neurological care exclusively at the study site for the duration of the RC+S INS lifespan (9 years). Exclusion Criteria: - Coagulopathy, anticoagulant medications that cannot be discontinued safely for perioperative period, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia, or other medical conditions considered to place the patient at elevated risk for surgical complications. - Pregnancy: All women of child-bearing age will have a negative urine pregnancy test prior to undergoing surgical procedures. - Significant untreated depression (BDI-II score > 20 or GDS score > 8). - 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 Parkinsons 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. - Patients with Obstructive Sleep Apnea. - Inability to perform the recharge process necessary for use of the RC+S system. |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | University of Pennsylvania Health System | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep efficiency | Sleep fragmentation frequency and duration will be measured using FDA-approved wrist-based Actigraphy (ActiWatch Spectrum Pro). | Years 1-3 | |
Primary | Subjective Sleep Quality | Change in subjective sleep quality will be measured between the 3 stimulation conditions. The measure will be captured using the Pittsburgh Sleep Diary. | Years 1-3 | |
Secondary | Duration of REM sleep stage | Change in the duration of REM stage sleep will be measured between the 3 stimulation conditions. We will use the artificial neural network to identify sleep stage and assess whether the duration changes as a function of stimulation protocol. | Years 1-3 |
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