--- title: Sensing brain stimulation lengthens sleep nct_id: NCT05070013 phase: NA status: RECRUITING sponsor: University of Nebraska study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT05070013" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05070013" last_fetched: "2026-05-10T14:04:47.945Z" source: "Parkinson's Pathways (curated)" --- # Sensing brain stimulation lengthens sleep **Goal (in five words):** Sensing brain stimulation lengthens sleep **Official Title:** Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease: An Investigation of STN LFP Biomarkers in Sleep Dysregulation and Repair **Trial ID:** [NCT05070013](https://clinicaltrials.gov/study/NCT05070013) ## Key Facts - **Phase:** NA - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** University of Nebraska - **Target Enrollment:** 20 participants - **Start Date:** 2021-11-18 - **Completion Date:** 2026-06-30 - **Conditions:** Parkinson's Disease, Sleep Fragmentation - **Interventions:** Deep Brain Stimulation - **Intervention Types:** DEVICE ## Summary For Families The goal is to reduce sleep fragmentation in Parkinson's, helping people get longer, more restorative stretches of sleep and repair disrupted sleep architecture that can worsen daytime function. The approach implants a sensing deep brain stimulator in the subthalamic nucleus that records local field potentials, uses those brain rhythms as biomarkers to trigger or adjust electrical stimulation during sleep, and thereby aims to consolidate sleep while working alongside stable levodopa and other anti-PD medications rather than replacing them. The study seeks adults 18 to 80 with idiopathic Parkinson's for at least 4 years who have significant motor problems despite optimized meds and who are approved for STN DBS, and excludes people with major cognitive impairment, severe untreated depression, obstructive sleep apnea, or restless legs. Participants must be able to get long-term follow up at the study site and manage the device recharge process. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 80 Years - **Sex:** ALL ### Full Criteria ``` Inclusion Criteria: * Signed informed consent * Diagnosis of Idiopathic Parkinson's disease (PD) with motor symptoms present for a minimum of 4 years * Severe motor symptoms (e.g., motor fluctuations, dyskinesia, tremor, bradykinesia, rigidity) despite optimized medical therapy, that warrant surgical implantation of deep 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, or 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 resulting in inadequate relief of motor symptoms as determined by a movement disorders neurologist, and stable dose of anti-PD medications for 30 days prior to study enrollment * Requested and approved for subthalamic nucleus deep brain stimulation surgery (STN DBS) by study site Multi-Disciplinary Movement Disorders Patient Care Conference * Absence of abnormalities on brain magnetic resonance imaging (MRI) scan suggestive of an alternate diagnosis or serving as a contraindication to surgery * Absence of significant cognitive deficits or significant depression (Beck Depression Inventory-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 duration of the RC+S INS neurostimulator device lifespan (9 years) Exclusion Criteria: * Any medical condition considered to elevate risk for surgical complications, such as coagulopathy,, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia, or anticoagulant medications that cannot be safely discontinued for perioperative period * Pregnancy (women of child-bearing potential must have a negative urine pregnancy test prior to surgical procedures) * Significant untreated depression (Beck Depression Inventory-II, BDI-II \> 20 or Geriatric Depression Scale, GDS, score \> 8) * Personality or mood disorder symptoms that investigators believe will interfere with study requirements * Required ongoing treatment with electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (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 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 tests from 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 brain stimulation system ``` ## Locations (2) - University of Nebraska Medical Center, Omaha, Nebraska, United States _(41.2563, -95.9404)_ - Dulce Maroni, PhD — (CONTACT) — 402-836-9751 — dmaroni@unmc.edu - Andrew Schnaubelt, PhD — (CONTACT) — 402-559-4846 — andy.schnaubelt@unmc.edu - Aviva Abosch, MD, PhD — (PRINCIPAL_INVESTIGATOR) - University of Pennsylvania Health System, Philadelphia, Pennsylvania, United States _(39.9524, -75.1636)_ - NIda Firdous, MD — (CONTACT) — 215-829-6720 — nida.firdous@pennmedicine.upenn.edu - Marie Kerr, CCRP — (CONTACT) — 215-829-6720 — marie.kerr@pennmedicine.upenn.edu - Casey Halpern, MD — (PRINCIPAL_INVESTIGATOR) ## Central Contacts - Dulce Maroni, PhD — (CONTACT) — 402-836-9751 — dmaroni@unmc.edu --- *Canonical: https://parkinsonspathways.com/trial/NCT05070013* *HTML version: https://parkinsonspathways.com/trial/NCT05070013* *Source data: https://clinicaltrials.gov/study/NCT05070013*