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Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease

University of Nebraska · NCT04799470

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 19–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
10
US sites recruiting
1
Study start
May 10, 2021
Record last updated
July 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Novel DBS stimulation patterns

Conditions: Parkinson's Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Unversity of Nebraska Medical Center

    Omaha, NE 68118

    Site contact: Dulce Maroni, PhD · 402-215-3053 · dmaroni@unmc.edu

Study contacts (from the official record)

  • Dulce Maroni, PhD · 402-215-3053 · dmaroni@unmc.edu
  • Jonathan Nguyen · 402-836-9407 · jon.nguyen@unmc.edu
All neurology studies in Nebraska →
Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease (NCT04799470) | Bored Studies