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NCT06191874 · ClinicalTrials.gov registry record
Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 20
- Enrollment target
NCT06191874: Completed study, sponsored by Duke University.
NCT06191874 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06191874 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
The objective of this project is to evaluate next generation visualization tools and surgical targeting models for clinical deep brain stimulation (DBS). This study will evaluate the performance of HoloDBS software in comparison to the current standard (SOC) clinical planning tools to prepare for DBS surgery. The investigators hypothesize that HoloDBS will provide more detailed and anatomically useful information to the neurosurgeon and neurologist than the current clinical standard. The study team reviews electronic medical records (EMR) from patients who are undergoing DBS surgery. There are no study visits involved in this study as only data from standard clinical care will be used. All study activities are executed by the study team and there are no interventions.
Primary Outcome
Comparison of the post-operative position of the DBS electrode to the location that was defined in the standard-of-care plan and the HoloDBS plan. The distance was calculated for each hemisphere for each participant as the distance between the actual post-operative electrode location and the location defined in the SOC plan (indicated as SOC) and the distance between the actual post-operative electrode location and the location defined in the HoloDBS plan (indicated as HoloDBS).
Interventions
- OTHER Standard-of-care (SOC) surgery plan
- OTHER HoloDBS hypothetical surgery plan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2025-05-29 |
What the finished NCT06191874 record still lists
NCT06191874 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Standard-of-care (SOC) surgery plan is the first listed.
NCT06191874 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06191874 about?
NCT06191874 is a clinical study titled "Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation". The objective of this project is to evaluate next generation visualization tools and surgical targeting models for clinical deep brain stimulation (DBS). This study will evaluate the performance of HoloDBS software in comparison to the current standard (SOC) clinical planning tools to prepare for D...
What is the current status of trial NCT06191874?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2024-03-01. Estimated completion is 2025-05-29.
What interventions are being tested in trial NCT06191874?
The interventions under investigation include: Standard-of-care (SOC) surgery plan (OTHER), HoloDBS hypothetical surgery plan (OTHER).
Who is sponsoring clinical trial NCT06191874?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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