Adaptive Neurostimulation for Parkinson's Disease Sleep Issues
Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease (Aim 2)
Recruiting
N/AInterventional Study
Parkinson's DiseaseSleep Fragmentation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
University of Nebraska · Other
Who this trial is looking for
This trial is looking for adults with Parkinson's Disease who have problems with sleep. Participants will receive a treatment to improve their sleep quality while also addressing motor symptoms associated with their condition.
Are You a Good Fit for This Trial?
Rules you outRestless Leg SyndromeObstructive Sleep Apnea
You may be able to join if
I have been diagnosed with Parkinson's disease for at least 4 years.
I have severe motor symptoms despite taking Parkinson's medications.
I have a UPDRS-III score between 20 and 80 when off medication.
I have not responded well to oral Parkinson's medications.
I am approved for deep brain stimulation surgery.
I am between 18 and 80 years old.
I can participate in follow-up care for up to 9 years.
You may not be able to join if
I have a medical condition that raises surgical risks.
I am currently pregnant.
I have significant untreated depression.
I have personality or mood disorders that may disrupt the study.
I am undergoing treatment with electroconvulsive therapy or similar.
I have a previously implanted stimulation system.
I have a history of drug or alcohol abuse.
I have conditions affecting my cognitive ability.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 lim…
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.
Trial Locations
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Eligibility 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 surgic…
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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