RecruitingNot ApplicableNCT05070013

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

Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease: An Investigation of STN LFP Biomarkers in Sleep Dysregulation and Repair


Sponsor

University of Nebraska

Enrollment

20 participants

Start Date

Nov 18, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a smart brain stimulation device (deep brain stimulation, or DBS) can be programmed to improve sleep in people with Parkinson's disease by responding in real time to brain signals during the night. **You may be eligible if...** - You are 18–80 years old and have had Parkinson's disease with motor symptoms for at least 4 years - Your motor symptoms (tremor, stiffness, slow movement) are severe despite medication - Your medical team has already recommended deep brain stimulation surgery - You have no major cognitive problems or severe depression - You are able to receive ongoing neurological care at the study site **You may NOT be eligible if...** - You have a pacemaker, cochlear implant, or other implanted electrical device - You have had prior brain surgery - You are pregnant - You have a history of significant alcohol or drug abuse - You have untreated or severe depression Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDeep 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.


Locations(2)

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

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NCT05070013


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