NCT04799470 · University of Nebraska
Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease
What this study is about
This is an where both patients and doctors know the treatment given, non-randomly assigned, 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.
View original scientific description
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.
Interventions
DEVICE
Novel DBS stimulation patterns
Stimulation patterns
Primary outcome measures
Safety and Tolerability of novel DBS stimulation patterns.
Time frame: Years 1-2
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Omaha, Nebraska
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 15, 2025 · Source of record for eligibility and locations