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NCT02424929 · ClinicalTrials.gov registry record · NA

Asleep Versus Awake Deep Brain Stimulation Surgery

A NA study, sponsored by Providence Medical Research Center.

Completed
Registry status
NA
Development phase
15
Enrollment target

NCT02424929 is a NA study that has completed, run by Providence Medical Research Center. The registered enrollment target is 15 participants.

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The verdict

NCT02424929, a NA study, has completed, sponsored by Providence Medical Research Center.

COMPLETED
Registry status
NA
Development phase
15 participants
Enrollment target

Study Summary

The goal of this study is to compare the surgical outcome of deep brain stimulation (DBS) surgery in patients who are deeply sedated, "asleep," or not sedated, "awake," during surgical implantation of the DBS electrode. The investigators hypothesize that the clinical outcome, neurophysiological findings, and surgical accuracy will be equivalent. There are 3 specific aims: 1) compare the activity of the neurons in the patients' brain in the asleep and awake groups using microelectrode recording, to see how this affects clinical outcome capability of microelectrode recordings and macrostimulation to identify the subthalamic nucleus in asleep patients. 2) Determine if intraoperative CT scans of the DBS electrode is sufficient for accurate DBS electrode placement. 3) Compare the clinical outcome on their Parkinson's disease between awake and asleep DBS patients.

Interventions

  • PROCEDURE Sedation
  • PROCEDURE Original Surgery

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2015-04
Est. Completion 2025-03
Phase NA

What the Registry Record Tells You About NCT02424929

The ClinicalTrials.gov registry entry for NCT02424929 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Providence Medical Research Center, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Sedation is the first listed.

NCT02424929 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02424929 about?

NCT02424929 is a clinical study titled "Asleep Versus Awake Deep Brain Stimulation Surgery". The goal of this study is to compare the surgical outcome of deep brain stimulation (DBS) surgery in patients who are deeply sedated, "asleep," or not sedated, "awake," during surgical implantation of the DBS electrode. The investigators hypothesize that the clinical outcome, neurophysiological find...

What is the current status of trial NCT02424929?

This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2015-04. Estimated completion is 2025-03.

What interventions are being tested in trial NCT02424929?

The interventions under investigation include: Sedation (PROCEDURE), Original Surgery (PROCEDURE).

Who is sponsoring clinical trial NCT02424929?

This trial is sponsored by Providence Medical Research Center, which has 4 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.