Scalar Closed Loop Intraoperative Study
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| ClinicalTrials.gov Identifier: NCT03270657 |
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Recruitment Status
:
Enrolling by invitation
First Posted
: September 1, 2017
Last Update Posted
: April 12, 2018
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Sponsor:
Duke University
Information provided by (Responsible Party):
Duke University
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease | Device: IPG; RC+S | Not Applicable |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 32 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Scalar Closed-Loop STN/GPi DBS Based on Evoked and Spontaneous Potentials (Intraoperative Studies) |
| Actual Study Start Date : | April 5, 2018 |
| Estimated Primary Completion Date : | February 27, 2022 |
| Estimated Study Completion Date : | February 27, 2022 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
|
IPG; RC+S
Subjects will be recruited and enrolled from individuals who have Parkinson's disease (PD) and who are scheduled to already undergo the planned deep brain electrode placement for treatment of their movement disorder.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.
|
Device: IPG; RC+S
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)
|
Primary Outcome Measures
:
- Accurately record evoked signals from DBS electrodes during DBS for Parkinson's Disease. [ Time Frame: End of procedure, approximately 45 minutes ]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.
Secondary Outcome Measures
:
- Measure DBS local evoked potentials (DLEPs) [ Time Frame: End of procedure, approximately 45 minutes ]The DLEP recordings will be serially averaged with stimulus-triggering to remove random noise while preserving the evoked response. The signal-to-noise ratios of DLEP recordings will be compared across data sets to determine which combination of stimulation and recording sites maximize recording quality.
- Measure spontaneous, local field potentials (LFPs) [ Time Frame: End of procedure, approximately 45 minutes ]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. The data set will consist of recordings of neural and/or LFP recordings, and either mouse click timing data for measurement of bradykinesia in Parkinson's disease subjects or tremor accelerometry data for patients with Parkinson's disease
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Parkinson's disease (PD) patients who are scheduled to already undergo the planned deep brain electrode placement for treatment of their movement disorder at Duke University Medical Center.
- Able to understand the study and consent form, and interested in proceeding with research during the invasive brain surgery to receive a DBS system for treatment of PD.
Exclusion Criteria:
- Inability to execute the motor tasks during the study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270657
Locations
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Duke University
Investigators
| Principal Investigator: | Dennis Turner, M.D. | Duke University |
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT03270657 History of Changes |
| Other Study ID Numbers: |
Pro00085076 |
| First Posted: | September 1, 2017 Key Record Dates |
| Last Update Posted: | April 12, 2018 |
| Last Verified: | April 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | Yes | |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes | |
| Pediatric Postmarket Surveillance of a Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Keywords provided by Duke University:
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Deep Brain Stimulation |
Additional relevant MeSH terms:
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |