MedTrace Logo

Closed Loop DBS Implanted RC+S Study

NCT03815656 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-02-18

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson Disease

Interventions

DEVICE

STN alone

DBS stimulation of STN alone

DEVICE

GPi alone

DBS stimulation of GPi alone

DEVICE

STN + GPi

cooperative DBS stimulation of STN and GPi sites

DEVICE

Closed-loop stimulation

adaptive DBS stimulation of STN and/or GPi sites

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Duke University

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Dennis Turner, M.D.

    lead OTHER

Principal Investigators

  • Dennis A Turner, M.D. · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-10
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03815656 on ClinicalTrials.gov