Suspended

State-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S

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What is being tested

Medtronic RC+S DBS system

Device
Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

From 45 to 75 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2019
See protocol details

Summary

Principal SponsorUniversity of Minnesota
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2019

Actual date on which the first participant was enrolled.

The Olympus Research System (RC+S) is an implantable pulse generator (IPG) designed to deliver deep brain stimulation (DBS) like a standard clinical neurostimulator, but which allows recordings of local field potential (LFP) activity from the implanted DBS lead. LFPs are composite electrical signals generated by the brain. They are conventionally divided into frequency bands, as follows: 0-3 Hz (delta), 4-7 Hz (theta), 8-12 Hz (alpha), 13-30 Hz (beta), 31-200 Hz (gamma), and >200 Hz (high frequency). The instantaneous amplitude and power of the LFP recordings are believed to represent the degree of synchronization among neurons surrounding the electrode. A transient increase in power in a particular band, in response to a behavioral event, is called an event-related synchronization (ERS), while a transient decrease in power is called event-related desynchronization (ERD). ERD and ERS are typically calculated by averaging the power across time segments and comparing this average to a reference epoch. Research staff at the University of Minnesota will follow FDA guidelines for software development for the RC+S.

Official TitleState-dependent Pathophysiological Oscillations in Parkinson's Disease and Treatment With DBS Using the Medtronic RC+S
NCT04011449
Principal SponsorUniversity of Minnesota
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 45 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesParkinson DiseaseNeurodegenerative DiseasesParkinsonian Disorders

Criteria

5 inclusion criteria required to participate
Diagnosis of idiopathic PD.
Age 45-75 years
Demonstrated good response (≥ 30%) to Sinemet or dopamine agonist medications as assessed by total UPDRS III score (off and on meds)
Clinical plan for unilateral STN- or GPi-DBS surgery to treat their clinical motor signs within the next four months
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12 exclusion criteria prevent from participating
Clinically significant medical disease that would increase the risk of developing pre- or post-operative complications (e.g., major cardiac or pulmonary disease)
Evidence of secondary or atypical parkinsonism
Dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain.
Unable to undergo MR imaging (e.g., due to incompatible implanted pacemaker)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Implantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Minnesota

Minneapolis, United StatesOpen University of Minnesota in Google Maps
SuspendedOne Study Center