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Adaptive Neurostimulation for Sleep in Parkinson's Disease

This study is testing a new way to improve sleep for people with Parkinson's Disease (PD) who also experience sleep problems like sleep fragmentation. It uses Deep Brain Stimulation (DBS), a device already used for PD motor symptoms. All 20 participants will receive three different types of stimulation during sleep over three weeks: adaptive stimulation, open-loop stimulation, and no stimulation. Researchers will measure how well you sleep (sleep efficiency), how long you sleep, and your personal rating of sleep quality. To join, you need to be 18-80 years old, have had PD for at least 4 years, and have severe motor symptoms that would make you eligible for DBS surgery. The study status is currently unclear.

Study design
This interventional study plans to enroll 20 participants. It compares adaptive stimulation, open-loop stimulation, and no stimulation during nighttime sleep.
What's involved
You would undergo three 1-week interventions of stimulation during nighttime sleep over three consecutive weeks. This would happen in your home after DBS implantation.
Compensation
Not stated in the trial record.
Follow-up
Sleep efficiency and subjective sleep quality will be measured at baseline (before surgery) and during the intervention period (approximately 144-172 days after surgery).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05070013

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

Recruiting
NAAges 18–80InterventionalTreatment
University of Nebraska
~20 participants
Updated 2025-07-22 on ClinicalTrials.gov
What's tested:Deep Brain Stimulation

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sleep Efficiency - Frequency
Measured over Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)
+2 more outcomes measured

Conditions

Parkinson's Disease
Sleep Fragmentation

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Parkinson Disease

NCT05070013

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Nebraska Medical Center

    Omaha, Nebraskastudy coordinator listed

    Recruiting

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Aviva Abosch, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Nebraska

Who to contact

Dulce Maroni, PhD
[email protected]
402-836-9751
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Sleep Efficiency - FrequencyBaseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)

    Sleep fragmentation frequency will be measured using FDA-approved wrist-based Actigraphy (ActiWatch Spectrum Pro). Comparisons will be made between baseline and each of the interventions.

  • Sleep Efficiency - DurationBaseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)

    Sleep fragmentation duration will be measured using FDA-approved wrist-based Actigraphy (ActiWatch Spectrum Pro). Comparisons will be made between baseline and each of the interventions.

  • Subjective Sleep QualityBaseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172)

    Subjective sleep quality will be assessed using the Pittsburgh Sleep Diary. Comparisons will be made between baseline and each of the interventions.