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โ† Trials
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Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease (Aim 2)

RecruitingNAAges 18 Years - 80 YearsAllUniversity of Nebraska
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In plain words

What the trial is, and whether it could suit you

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 elect

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Deep Brain Stimulation
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Where

2 sites
University of Nebraska Medical Center
Omaha, United States
University of Pennsylvania Health System
Philadelphia, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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