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NCT03283150 · ClinicalTrials.gov registry record · Phase 4
Deep Brain Stimulation (DBS) Sedation
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT03283150: Clinical Trial Phase 4 study, sponsored by University of Wisconsin, Madison.
NCT03283150 is a Phase 4 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03283150, a Phase 4 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
Deep brain stimulation (DBS) of different brain nuclei is a treatment for multiple brain disorders. The subthalamic nucleus (STN) and globus pallidus have been used to treat advanced Parkinson's disease for a long time. The ventral intermediate nucleus of the thalamus is an effective target for treating essential tremor patients. STN and the internal segment of the globus pallidus are useful targets for treating dystonia. To achieve this optimal electrode localization, many centers perform electrophysiological mapping of the target nuclei using microelectrode recording (MER). This way they can achieve precise localization of the electrode. During the mapping procedure, microelectrodes are passed through the target nuclei, and the electrical neuronal activity is observed and recorded. The surgical team can identify the precise location of the target nuclei and its borders according to the typical activity of its neurons. This study will compare the activity of neurons in several DBS targets before, during and after sedation with propofol, remifentanil and dexmedetomidine. The goal is to understand the effects of anesthetics on the neuronal activity in these targets, allowing us to choose the most appropriate sedation protocol to use during implantation of DBS electrodes in deep brain structures (bearing in mind that each structure may have a different optimal protocol).
Primary Outcome
Effects of propofol, remifentanil and dexmedetomidine on the neuronal activity during microelectrode recording (MER) in different brain structures that are used as target for DBS implantation will be measure. The RMS of the electrical activity as a measure of the spiking rate of neurons in the vicinity of the electrode tip. normalize the RMS to the baseline value recorded at the first 2-5 minutes of MER (before entering the target area) to compensate for differences between patients and recordi
Interventions
- DRUG Dexmedetomidine
- DRUG Propofol
- DRUG Remifentanil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2022-01-20 |
| Phase | Phase 4 |
Why NCT03283150 stopped before completion
NCT03283150 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexmedetomidine is the first listed.
NCT03283150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03283150 about?
NCT03283150 is a clinical study titled "Deep Brain Stimulation (DBS) Sedation". Deep brain stimulation (DBS) of different brain nuclei is a treatment for multiple brain disorders. The subthalamic nucleus (STN) and globus pallidus have been used to treat advanced Parkinson's disease for a long time. The ventral intermediate nucleus of the thalamus is an effective target for trea...
What is the current status of trial NCT03283150?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2017-12-01. Estimated completion is 2022-01-20.
What interventions are being tested in trial NCT03283150?
The interventions under investigation include: Dexmedetomidine (DRUG), Propofol (DRUG), Remifentanil (DRUG).
Who is sponsoring clinical trial NCT03283150?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03283150's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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