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NCT03630302 · ClinicalTrials.gov registry record
Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 10
- Enrollment target
NCT03630302: Completed study, sponsored by Abbott Medical Devices.
NCT03630302 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03630302 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
Study Summary
The current study aims to explore the functional use of LFPs recorded intraoperatively for the optimization of a directional DBS lead programming Aim-1: To determine whether intraoperative LFPs recorded from the segmented DBS electrode can predict the optimal stimulation parameters. Aim-2: Compare the therapeutic window for stimulation delivered through directional and conventional leads and determine if the spatiospectral LFP patterns correlate with the presence of stimulation side effects.
Primary Outcome
From all DBS leads (2 per patient): Local field potentials (LFPs) were measured intraoperatively during DBS implant. Features such as beta band power (10-30Hz), high-frequency oscillation power (200-400Hz, HFO), as well as the cross frequency coupling between beta band power and HFO (CFC) were extracted from the LFP recordings from all electrodes. Electrodes with the most beta band power, most HFOs, and most CFC were documented. At 3 month post-op visit, the clinically programmed stimulation e
Interventions
- DEVICE DBS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-07-12 |
| Est. Completion | 2020-01-31 |
What the finished NCT03630302 record still lists
NCT03630302 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which DBS is the first listed.
NCT03630302 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03630302 about?
NCT03630302 is a clinical study titled "Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy". The current study aims to explore the functional use of LFPs recorded intraoperatively for the optimization of a directional DBS lead programming Aim-1: To determine whether intraoperative LFPs recorded from the segmented DBS electrode can predict the optimal stimulation parameters. Aim-2: Compare...
What is the current status of trial NCT03630302?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2018-07-12. Estimated completion is 2020-01-31.
What interventions are being tested in trial NCT03630302?
The interventions under investigation include: DBS (DEVICE).
Who is sponsoring clinical trial NCT03630302?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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