Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedStudy Start
First participant enrolled
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedAugust 15, 2025
August 1, 2025
4.9 years
March 12, 2021
August 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability of novel DBS stimulation patterns.
To assess if the novel stimulation patterns provide similar side effect profile, when compared to standard clinical stimulation, tolerability will be assessed by: 1. Number of study participants experiencing stimulation-related side effects. Side effects will be measured as patient-reported severity and type of side effect. 2. Number of study participants experiencing stimulation-related Adverse Events.
Years 1-2
Secondary Outcomes (1)
Response to novel DBS stimulation patterns.
Years 1-2
Study Arms (1)
PD with DBS
EXPERIMENTALPatients with Parkinson's Disease who were implanted with Medtronic Percept PC for DBS and consent to participate in the study.
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68118, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aviva Abosch, MD, PhD
University of Nebraska
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2021
First Posted
March 16, 2021
Study Start
May 10, 2021
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
August 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share