Recruiting

Neurostimulation

Sponsor:

University of Nebraska

Code:

NCT05070013

Conditions

Parkinson's Disease

Sleep Fragmentation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation

Study Details

Brief summary:

Parkinson's Disease (PD) is the second most common of the age-related neurodegenerative disorders, affecting over 1,900 adults per 100,000 over the age of 80 in the US. The prevalence of sleep dysfunction in PD is estimated at nearly 80-90% which includes sleep fragmentation, insomnia, rapid eye movement (REM or dream sleep) Sleep Behavior Disorder (RBD), Restless legs syndrome (RLS), periodic limb movement, excessive daytime sleepiness, and sleep apnea. Sleep is vital to homeostasis, cognition, and nervous system repair. The dysfunctional sleep accompanying PD adversely affects both motor and non-motor symptoms, resulting in diminished quality of life for both patients and caregivers, including impairments in mood and behavior, and increased morbidity and mortality. Knowledge of sleep phenomenology and pathology in humans has largely been informed by analysis of non-invasive scalp electroencephalogram (EEG), and despite the profound importance of sleep, the underlying neural circuits important for controlling sleep and wakefulness in humans remain poorly understood.

This study assesses whether adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Participants are adults with PD 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). Prior to surgery, participant sleep patterns will be assessed with questionnaires and monitored with a non-invasive watch-like device. Approximately four months after implantation surgery, participants will each receive 2 1-week deep brain stimulation (DBS) treatments and 1 1-week control session with no DBS in random order. Sleep patterns will again be monitored during the treatments and compared to the patterns before surgery.

Conditions

Parkinson's Disease

Sleep Fragmentation

Study ID

NCT05070013

Start date

Nov 18, 2021

Status verified date

May, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adaptive Deep Brain Stimulation

Participants will be given adaptive deep brain stimulation (DBS) during one week of at-home night sleep.

active comparator: Open-loop Deep Brain Stimulation

Participants will be given open-loop deep brain stimulation (DBS) (standard clinical stimulation therapy based on (DBS) programming for the treatment of motor symptoms) during one week of at-home night sleep.

no intervention: No Deep Brain Stimulation

Deep brain stimulation (DBS) is turned off (control) during one week of at-home night sleep.

Interventions

Deep Brain Stimulation

All participants will undergo three 1-week interventions of stimulation during nighttime sleep over the course of three consecutive weeks of in-home sleep: adaptive stimulation, open-loop stimulation and no stimulation.

Primary outcome measure

  • Sleep Efficiency - Frequency [ Time Frame: Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172) ]
  • Sleep Efficiency - Duration [ Time Frame: Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172) ]
  • Subjective Sleep Quality [ Time Frame: Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172) ]

Central Contacts and Locations

Central contacts

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Principal Investigator:

Aviva Abosch, MD, PhD

University of Pennsylvania Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19106

Contacts

Principal Investigator:

Casey Halpern, MD

More Information

Sponsor

University of Nebraska

Last update posted

Jul 22, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Nebraska on 2025-07-22.