CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled
Drug / intervention
IPG; RC+Sdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03270657
NCT03270657N/ACompleted

Scalar Closed-Loop STN/GPi DBS Based on Evoked and Spontaneous Potentials (Intraoperative Studies)

Dennis Turner, M.D.·interventional·Posted Sep 1, 2017·Updated Mar 23, 2020

In Brief

A clinical study evaluating IPG; RC+S for Parkinson Disease. Completed, enrolled 5 participants across 1 site.

Detailed Summary

The purpose of this study is to measure neural activity during deep brain stimulation (DBS). There are two types of neural activity that we will record from DBS electrodes during this study: DBS local evoked potentials (DLEPs) and spontaneous, local field potentials (LFPs). We will measure the effects of varying stimulation parameters on both the neural activity and changes in motor symptoms -- bradykinesia and tremor -- in subjects with Parkinson's disease (PD). Correlating neural activity characteristics with changes in symptoms will improve our understanding of the mechanisms of action of DBS. This intraoperative study will specifically compare our ability to record neural activity using circuitry developed at Duke for this purpose \[Kent et al, 2015\] to a new, implanted pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S (that is not designed for implantation), and will lead to a clinical trial assessing the efficacy of the implantable RC+S IPG in PD patients once this device is available and approved for this trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 1, 2017
Enrollment StartApr 5, 2018
Primary CompletionMar 26, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.8 years ago

Interventions

IPG; RC+Sdevice

We will measure the effects of varying stimulation parameters on the neural activity in subjects with Parkinson's disease (PD).