No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
University of Nebraska · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease who have a Medtronic Percept PC device already implanted. Participants will receive different stimulation patterns to see how they affect their symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with idiopathic Parkinson's Disease.
I have a Medtronic Percept PC implanted.
I am optimized for clinical stimulation and medication for at least 3 months after my DBS surgery.
I consent to participate in the study.
I have a robust beta peak as detected by the device.
I have a good response to stimulation, improving my UPDRS III score by at least 30%.
You may not be able to join if
I am not currently implanted with the Medtronic Percept INS.
I do not want to participate in the study.
I have unstable stimulation that needs frequent adjustments.
I experience significant side effects from stimulation.
I need unusual programming parameters for my device.
I have an implanted cardiac device.
My Medtronic Percept PC indicates it needs replacement at the start of the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 ef…
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.
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Eligibility 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, histor…
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
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