Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT04799470
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Novel DBS stimulation patterns — DEVICE
    Stimulation patterns

Study Details

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.

Key Dates

Start date
May 10, 2021
Status verified
Aug 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PD with DBS
    Patients with Parkinson's Disease who were implanted with Medtronic Percept PC for DBS and consent to participate in the study.

Primary Outcome Measure

Safety and Tolerability of novel DBS stimulation patterns. [ Time Frame: Years 1-2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Unversity of Nebraska Medical CenterOmahaNebraska68118
Dulce Maroni, PhD
[email protected]
402-215-3053

Find similar trials in Omaha, NE

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Unversity of Nebraska Medical Center· Omaha, NE

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