Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Parkinson's Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Device Feasibility

Participation Requirements

Age
Between 19 years and 80 years
Gender
Both males and females

Description

Parkinson's disease (PD) is a neurodegenerative disorder characterized by both motor and non-motor symptoms. Motor symptoms of PD include the clinical triad of tremor, rigidity, and bradykinesia, and typically lead to the initial diagnosis. While there is yet no cure for PD, medical and surgical the...

Parkinson's disease (PD) is a neurodegenerative disorder characterized by both motor and non-motor symptoms. Motor symptoms of PD include the clinical triad of tremor, rigidity, and bradykinesia, and typically lead to the initial diagnosis. While there is yet no cure for PD, medical and surgical therapies have been developed that effectively target the motor symptoms of PD. Patients with PD who demonstrate significant motor fluctuations and dyskinesia are considered for subthalamic nucleus (STN) deep brain stimulation (DBS) surgery. Therapeutic DBS leads to a reduction in pathological neuronal synchronization seen in PD. While continuous high-frequency stimulation is effective for ameliorating motor symptoms, the investigators hypothesize that different stimulation patterns which are designed to better target excessive synchrony in a patient-tailored manner, may result in more efficient and effective therapy with fewer side effects. This overarching hypothesis is supported by prior foundational preclinical and clinical research. Medtronic has developed proprietary technology that allows implantable neural stimulators (INS) to deliver both standard clinical electrical stimulation therapy and to record bioelectric data (i.e. local field potentials; LFPs) through DBS leads implanted in the brain. Medtronic's 3rd-generation sensing DBS INS, Percept PC, is FDA-approved for treating PD and can be used to explore unique biomarkers of brain state changes associated with activities of daily living and disease symptomatic states. This research will use Percept PC INS latent capabilities to deliver research stimulation. The proposed research stimulation pattern involves cycling stimulation On/Off across multiple electrode contacts. Importantly, all stimulation in this research project will be delivered using charge-balanced pulses, in compliance with all FDA safety guidelines including frequency (? 250 Hz) and charge density (30 µC/cm2/phase). At the conclusion of the research study, standard clinical stimulation will be re-activated.

Tracking Information

NCT #
NCT04799470
Collaborators
Not Provided
Investigators
Principal Investigator: Aviva Abosch, MD, PhD University of Nebraska