Using neurostimulation to improve sleep in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of an adaptive neurostimulation algorithm designed to enhance sleep quality in patients with Parkinson's disease (PD) who experience severe sleep fragmentation. By utilizing local field potentials recorded from deep brain stimulation electrodes in the subthalamic nucleus, researchers aim to identify and modulate sleep-related neural activity. Participants will undergo a series of assessments, including actigraphy and polysomnography, before and after the surgical implantation of deep brain stimulation devices. The study will compare the effects of chronic open-loop stimulation, adaptive stimulation, and a no-stimulation control group in a randomized, blinded manner.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting
• University of Pennsylvania Health System
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Aviva Abosch, MD, PhD — University of Nebraska
• Study coordinator: Dulce Maroni, PhD
• Email: dmaroni@unmc.edu
• Phone: 402-836-9751

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.