BENITIONSClinical Trial Intelligence

Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation

단계 해당 없음 완료 NCT06191874

대상 질환Deep Brain Stimulation
임상 단계단계 해당 없음
스폰서Duke University
상태완료
참여자 수22 명
중재(약물)Standard-of-care (SOC) surgery plan, HoloDBS hypothetical surgery plan
시작일2024년 3월 1일
완료일2025년 5월 29일
결과 공개일2026년 7월 24일

요약

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

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