Closed Loop DBS Implanted RC+S Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-10

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study involves patients who are already planning to have deep brain stimulation (DBS) surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals:

1. to evaluate the effectiveness of implanting DBS electrodes in the two most common locations for DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)), instead of just one electrode, on each side of the brain; and
2. to develop an adaptive DBS system using brain signals measured from these two electrodes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Scalar Closed Loop Intraoperative Study

NCT03270657

Parkinson Disease

COMPLETED NA

Closed-loop DBS in Parkinson's Disease

NCT06012461

Parkinson Disease

RECRUITING NA

Low Frequency Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease

NCT03204526

Parkinson Disease Cognitive Impairment

COMPLETED NA

Subthalamic Nucleus Versus Globus Pallidal Internus Deep Brain Stimulation for Parkinson Disease

NCT07250685

PD - Parkinson's Disease

NOT_YET_RECRUITING NA

Deep Brain Stimulation for Parkinson's Disease Trial

NCT00053625

Parkinson's Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is a small, first in man, clinical feasibility trial for patients with severe Parkinson's Disease (PD), who are already clinically eligible for deep brain stimulation (DBS) with two goals:

1. to compare efficacy from two common sites of DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)) through the implantation of dual DBS electrodes on each side of the brain; and
2. to develop a closed loop DBS system using evoked and spontaneous potentials derived from these two electrodes.

The study will involve bilateral dual DBS electrode placement in clinically standard locations (ie, STN and GPi) unilaterally or (more often) bilaterally, the placement of the RC+S Medtronic research implantable pulse generator (IPG), and a commitment to return for both extensive postoperative programming and testing to define clinical efficacy and separate research days to develop the closed loop approach. In addition, patients will undergo intraoperative research using temporary percutaneous extensions to the DBS electrode(s) and DBS lead cannula after implantation to confirm the electrode location and to identify what the signals will look like during later chronic recordings through the research IPG.

The research RC+S IPG includes both ordinary DBS stimulation as well as a recording system that simultaneously measures the DBS local evoked potential (DLEP) and/or local field potential (LFP) responses from either the same or a second DBS electrode.

In a separate cohort, we are enrolling healthy volunteers as blinded raters of audio recordings made by people with Parkinson's disease and without Parkinson's disease to study whether different features of speech patterns are specific to PD and whether there are measurable differences in these speech features when PD participants are on different deep brain stimulation settings. These ratings do not contribute to the primary or secondary endpoints of this study.

Study design details listed in this record are specific to the Implanted RC+S clinical trial cohort.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Implanted RC+S

Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.

Group Type EXPERIMENTAL

STN alone

Intervention Type DEVICE

DBS stimulation of STN alone

GPi alone

Intervention Type DEVICE

DBS stimulation of GPi alone

STN + GPi

Intervention Type DEVICE

cooperative DBS stimulation of STN and GPi sites

Closed-loop stimulation

Intervention Type DEVICE

adaptive DBS stimulation of STN and/or GPi sites

speech rater

blinded raters to score audio recordings of speech

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

STN alone

DBS stimulation of STN alone

Intervention Type DEVICE

GPi alone

DBS stimulation of GPi alone

Intervention Type DEVICE

STN + GPi

cooperative DBS stimulation of STN and GPi sites

Intervention Type DEVICE

Closed-loop stimulation

adaptive DBS stimulation of STN and/or GPi sites

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* able to give informed consent
* diagnosed with Parkinson's Disease and is considered a surgical candidate for DBS
* has medication-related side effects from levodopa (i.e., dyskinesias, on-off fluctuations)
* has off-on improvement with levodopa of at least 30%
* is available for follow-up visits for length of study

* able to give informed consent
* has no hearing impairment (by self-report)
* is a native English speaker

Exclusion Criteria

* is not safe surgical candidate for DBS
* has severe neurological injury or disease other than Parkinson's Disease
* has condition requiring repeated MRI scans
* has untreated, clinically significant depression
* has an electrical or electromagnetic implant
* had a prior thalamotomy or surgical ablation procedure
* has dementia interfering with ability to comply with study requirements or give informed consent
* abuses drugs or alcohol
* has a history of seizures
* has any metallic implants
* is pregnant

* is a speech therapist or clinician in a related field
* studies linguistics / logopedics

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No