Actively Recruiting
Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease
Led by University of Nebraska · Updated on 2025-08-15
10
Participants Needed
1
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with idiopathic Parkinson's Disease recommended for STN DBS using standard clinical criteria
- Previously implanted with bilateral STN DBS and Medtronic Percept PC device
- Optimized for clinical stimulation and medication for at least 3 months post-surgery
- Consent to participate in the study
- Presence of a robust beta peak (≥ 0.7 µV/rtHz) detected intra-operatively
- Good response to stimulation with at least 30% improvement on UPDRS III compared to baseline OFF, at least 3 months post-surgery
You will not qualify if you...
- Not currently implanted with the Medtronic Percept implantable neural stimulator
- Not willing to participate in the study
- Unstable stimulation requiring frequent reprogramming or adjustment
- Significant stimulation-induced side effects
- Need for unusual programming parameters such as very high (> 200 Hz) or low (< 100 Hz) frequencies
- Presence of an implanted cardiac device
- Medtronic Percept PC device indicates elective-replacement-indicated (ERI) at study start
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Unversity of Nebraska Medical Center
Omaha, Nebraska, United States, 68118
Actively Recruiting
Research Team
D
Dulce Maroni, PhD
CONTACT
J
Jonathan Nguyen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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