RecruitingNot ApplicableNCT04799470

Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease

Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease - UNMC/Medtronic Collaborative Acute Feasibility Pilot


Sponsor

University of Nebraska

Enrollment

10 participants

Start Date

May 10, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, non-randomized, proof-of-concept comparison of clinical vs. research stimulation patterns in patients with Parkinson's disease (PD) being treated with Deep Brain Stimulation (DBS) through the Medtronic Percept PC DBS device. The investigators hypothesize that stimulation patterns designed to better target excessive synchrony in a patient-tailored manner may result in more efficient and effective therapy with fewer side effects. Medtronic 3rd-generation sensing implantable neural stimulator, Percept PC, is FDA-approved for treating PD. The Percept PC device features BrainSense, the first and only available sensing technology for deep brain stimulation. BrainSense technology allows the device to capture and record brain signals (local field potentials, or LFP) using the brain-implanted DBS lead, while simultaneously delivering therapeutic stimulation. Investigators plan to enroll and complete investigations in 15 study subjects total, who have been previously implanted with the Medtronic Percept PC for the treatment of PD, and who are optimized for clinical stimulation and anti-Parkinsons medication. Investigations will be performed in UNMC Movement Disorders Clinic, UNMC Neurosurgery Lab, and UNO Biomechanics Research Building, Gait Lab. Subjects will receive research stimulation patterns and the effect on PD motor symptoms will be assessed via Unified Parkinsons Disease Rating Scale (UPDRS)-part III and gait measures. Videotaping of patient UPDRS-III testing and gait will be obtained.


Eligibility

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new patterns of electrical brain stimulation (deep brain stimulation, or DBS) in people with Parkinson's disease to see if these new patterns work better than the standard approach at reducing tremors and movement problems while potentially having fewer side effects. **You may be eligible if...** - You have been diagnosed with Parkinson's disease - You have already been recommended for deep brain stimulation surgery based on standard clinical criteria - You are willing to try different stimulation settings during the study **You may NOT be eligible if...** - You have a blood clotting disorder - You have dementia or untreated depression - You have a pre-existing implanted brain or nerve stimulation device - You have had prior brain surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENovel DBS stimulation patterns

Stimulation patterns


Locations(1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

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NCT04799470


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