Recruiting

DBS Stimulation

Sponsor:

University of Nebraska

Code:

NCT04799470

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Interventions

Novel DBS stimulation patterns

Study Details

Brief 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.

Conditions

Parkinson's Disease

Study ID

NCT04799470

Start date

May 10, 2021

Status verified date

Jul, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients with idiopathic Parkinson's Disease who were recommended for STN DBS using standard clinical inclusion and exclusion criteria (e.g., presence of coagulopathy, dementia, untreated depression, pre-existing implanted stimulation system, prior intracranial surgery, history of alcohol or drug abuse)
  • Patients have been previously implanted with bilateral STN DBS and the Medtronic Percept PC implantable neural stimulator.
  • Patients are optimized for clinical stimulation and medication for at least 3 months post-surgery for the implantation of their DBS system.
  • Consent to study participation
  • Presence of a robust beta peak (detectable using the Percept BrainSense Survey feature; ≥ 0.7 µV/rtHz), intra-operatively (assessed via Lead Confirm technology from Alpha Omega)
  • Good response to stimulation (30% improvement on UPDRS III compared to baseline OFF), at least 3 months post-surgery.

Exclusion Criteria:

  • Not currently implanted with the Medtronic Percept INS
  • Not willing to participate in the study
  • Unstable stimulation with need for frequent reprogramming or further adjustment
  • Significant stimulation-induced side effects
  • Need for unusual programming parameters such as very high (> 200 Hz) or low (< 100) frequencies (due to cycle limitations)
  • The patient has an implanted cardiac device
  • The patients Medtronic Percept TM PC indicates elective-replacement-indicated (ERI) at the start of the study

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Novel DBS stimulation patterns

Stimulation patterns

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Dulce Maroni, PhD

402-215-3053dmaroni@unmc.edu

Jonathan Nguyen

402-836-9407jon.nguyen@unmc.edu

Locations

Unversity of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68118

Contacts

Dulce Maroni, PhD

402-215-3053dmaroni@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-07-22.