Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease - The DREAMS-PD Study
The Cleveland Clinic
Summary
This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention.
Description
Deep brain stimulation (DBS) stands as an established and robust treatment for various motor symptoms in patients with Parkinson's disease (PWP). While it has shown promise in ameliorating non-motor symptoms, the mechanisms underlying these improvements remain poorly understood. A significant forthcoming shift in the DBS landscape is the transition towards closed-loop or "adaptive DBS" (aDBS). This approach relies on expanding knowledge of basal ganglia electrophysiology and its correlation with motor symptoms. Augmented beta frequency oscillations (13-35 Hz) in local field potentials (LFP) fr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female \> 18 years of age * Diagnosed with idiopathic Parkinson Disease * Have bilateral implantation of Medtronic's PerceptTM PC (Medtronic Neurological Division, Minneapolis, MN, USA) Deep Brain Stimulation (DBS) system targeting the subthalamic nucleus (STN) and have had their stimulation settings optimized for a minimum of three months * Report a response score of one or greater on question 1.7 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I; * Demonstrate ability to ambulate independently; * Be capable of providin…
Interventions
- OtherNighttime Deep Brain Stimulation with Varying Amplitude Settings
Participants will undergo three different nighttime-only Deep Brain Stimulation (DBS) settings in a randomized crossover design: 0% amplitude (stimulation off), 50% amplitude of their optimal clinical DBS settings, and full clinical DBS settings (100%). Each setting is applied for two weeks during sleep, over a total six-week home monitoring period. The intervention is designed to assess how varying levels of subthalamic nucleus DBS influence sleep quality and neural oscillatory activity. Only nighttime DBS settings are modified; daytime settings remain unchanged.
Location
- Cleveland ClinicCleveland, Ohio