BENITIONSClinical Trial Intelligence

Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation

N/A Completed NCT06191874

ConditionDeep Brain Stimulation
PhaseN/A
SponsorDuke University
StatusCompleted
Enrollment22 participants
InterventionsStandard-of-care (SOC) surgery plan, HoloDBS hypothetical surgery plan
Start dateMar 1, 2024
Completion dateMay 29, 2025
Results postedJul 24, 2026

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.

Distance Between the Actual Post-operative Location of the DBS Electrode and the Planned Location

1 month after surgery · mm

Surgery Planning by SOC Methods, Then by HoloDBS2.44 ± 0.90 mm
Surgery Planning by HoloDBS, Then by SOC Methods2.85 ± 1.94 mm
Surgery Planning by SOC Methods, Then by HoloDBS1.99 ± 0.86 mm
Surgery Planning by HoloDBS, Then by SOC Methods1.82 ± 0.83 mm
p-value0.1559

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.