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NCT03270657 · ClinicalTrials.gov registry record · NA
Scalar Closed Loop Intraoperative Study
A NA study of Parkinson Disease, sponsored by Dennis Turner, M.D..
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT03270657: Completed NA study of Parkinson Disease, sponsored by Dennis Turner, M.D..
NCT03270657 is a NA study of Parkinson Disease that has completed, run by Dennis Turner, M.D.. The registered enrollment target is 5 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03270657, a NA study of Parkinson Disease, has completed, sponsored by Dennis Turner, M.D..
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measured by the ability to record neural activity through DBS electrodes using circuitry developed at Duke for this purpose and/or a new implantable 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.
Conditions Studied
Interventions
- DEVICE IPG; RC+S
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-04-05 |
| Est. Completion | 2019-03-26 |
| Phase | NA |
What the finished NCT03270657 record still lists
NCT03270657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 1 intervention - of which IPG; RC+S is the first listed.
NCT03270657 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03270657 about?
NCT03270657 is a clinical study titled "Scalar Closed Loop Intraoperative Study". 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 effec...
What is the current status of trial NCT03270657?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2018-04-05. Estimated completion is 2019-03-26.
What conditions does trial NCT03270657 study?
This clinical trial studies the following conditions: Parkinson Disease.
What interventions are being tested in trial NCT03270657?
The interventions under investigation include: IPG; RC+S (DEVICE).
Who is sponsoring clinical trial NCT03270657?
This trial is sponsored by Dennis Turner, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03270657 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03270657's enrollment target sits among peer trials
5 292nd of 297 higher than 5 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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