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NCT00792532 · ClinicalTrials.gov registry record
Use of Interventional MRI for Implantation of Deep Brain Stimulator Electrodes
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 8
- Enrollment target
NCT00792532 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 8 participants.
The verdict
NCT00792532 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
Study Summary
The purpose of this study is to gather observational data on an already FDA-approved implantation technique for deep brain stimulation (DBS) in which the entire surgery is performed within an MRI scanner ("interventional MRI", or iMRI). With this surgical technique, the patient is fully asleep (under general anesthesia) during DBS implantation. The standard method for the placement of deep brain stimulators does not use MRI during the actual DBS placement. The standard method involves placement of a rigid frame on the patient's head, performance of a short MRI scan, transport to the operating room, placement of the DBS electrodes in the operating room, and return to the MRI suite for another MR to confirm correct electrode placement. In the standard method, the patient must be awake for 2-4 hours in the operating room to have "brain mapping" performed, where the brain target is confirmed by passing "microelectrodes" (thin wires) into the brain to record its electrical activity. In the standard method, general anesthesia is not required. With the iMRI technique, the surgery is guided entirely by MRI images performed multiple times as the DBS electrode is advanced. This eliminates the need for the patient to be awake, and eliminates the need for passing microelectrodes into the brain before placing the permanent DBS electrode.
Interventions
- PROCEDURE interventional MRI for implantation of DBS electrodes
- DEVICE DBS electrodes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2003-07 |
| Est. Completion | 2019-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00792532
The ClinicalTrials.gov registry entry for NCT00792532 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which interventional MRI for implantation of DBS electrodes is the first listed.
NCT00792532 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00792532 about?
NCT00792532 is a clinical study titled "Use of Interventional MRI for Implantation of Deep Brain Stimulator Electrodes". The purpose of this study is to gather observational data on an already FDA-approved implantation technique for deep brain stimulation (DBS) in which the entire surgery is performed within an MRI scanner ("interventional MRI", or iMRI). With this surgical technique, the patient is fully asleep (unde...
What is the current status of trial NCT00792532?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2003-07. Estimated completion is 2019-03.
What interventions are being tested in trial NCT00792532?
The interventions under investigation include: interventional MRI for implantation of DBS electrodes (PROCEDURE), DBS electrodes (DEVICE).
Who is sponsoring clinical trial NCT00792532?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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