NCT04799470Recruiting
Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease
Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease - UNMC/Medtronic Collaborative Acute Feasibility Pilot
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 12 Mar 2021
- Start date
- 10 May 2021
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- University of Nebraska
- Diseases
- Parkinson disease
- NCT number
- NCT04799470
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 10 May 2021 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- The patient has an implanted cardiac device
Other
- 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 patients Medtronic Percept TM PC indicates elective-replacement-indicated (ERI) at the start of the study
Who the study is looking for
- 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.
Age in the registry: 19 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unversity of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.