Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease

August 11, 2025 updated by: University of Nebraska

Novel DBS Stimulation Patterns for Treatment of Parkinson's Disease - UNMC/Medtronic Collaborative Acute Feasibility Pilot

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Parkinson's disease (PD) is a neurodegenerative disorder characterized by both motor and non-motor symptoms. Motor symptoms of PD include the clinical triad of tremor, rigidity, and bradykinesia, and typically lead to the initial diagnosis. While there is yet no cure for PD, medical and surgical therapies have been developed that effectively target the motor symptoms of PD. Patients with PD who demonstrate significant motor fluctuations and dyskinesia are considered for subthalamic nucleus (STN) deep brain stimulation (DBS) surgery. Therapeutic DBS leads to a reduction in pathological neuronal synchronization seen in PD. While continuous high-frequency stimulation is effective for ameliorating motor symptoms, the investigators hypothesize that different stimulation patterns which are designed to better target excessive synchrony in a patient-tailored manner, may result in more efficient and effective therapy with fewer side effects. This overarching hypothesis is supported by prior foundational preclinical and clinical research. Medtronic has developed proprietary technology that allows implantable neural stimulators (INS) to deliver both standard clinical electrical stimulation therapy and to record bioelectric data (i.e. local field potentials; LFPs) through DBS leads implanted in the brain. Medtronic's 3rd-generation sensing DBS INS, Percept PC, is FDA-approved for treating PD and can be used to explore unique biomarkers of brain state changes associated with activities of daily living and disease symptomatic states.

This research will use Percept PC INS latent capabilities to deliver research stimulation. Importantly, all stimulation in this research project will be delivered using charge-balanced pulses, in compliance with all FDA safety guidelines including frequency (≤ 250 Hz) and charge density (30 µC/cm2/phase). At the conclusion of the research study, standard clinical stimulation will be re-activated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • Unversity of Nebraska Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PD with DBS
Patients with Parkinson's Disease who were implanted with Medtronic Percept PC for DBS and consent to participate in the study.
Device: Novel DBS stimulation patterns
Stimulation patterns

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Years 1-2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Response to novel DBS stimulation patterns.
Time Frame: Years 1-2

To assess if the novel stimulation patterns provide similar motor symptom benefit, when compared to standard clinical stimulation, response will be assessed by:

  1. UPDRS Part III exam instrumented with inertial sensors will provide severity scores from 0-4 for tremor, bradykinesia, rigidity and dyskinesia.
  2. Balance and gait measures will be obtained by inertial sensors placed in the extremities.
Years 1-2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aviva Abosch, MD, PhD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0865-20-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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