Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation

• Conditions: Deep Brain Stimulation
• Interventions: Other: Standard-of-care (SOC) surgery plan; Other: HoloDBS hypothetical surgery plan

• Registration Number: NCT06191874
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2024-01-03
• Study First Posted: 2024-01-05
• Study Start: 2024-03-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery planning by SOC methods, then by HoloDBS	Standard-of-care (SOC) surgery plan	Standard-of-care (SOC) surgery plan is built before the HoloDBS hypothetical surgery plan
Surgery planning by SOC methods, then by HoloDBS	HoloDBS hypothetical surgery plan	Standard-of-care (SOC) surgery plan is built before the HoloDBS hypothetical surgery plan
Surgery planning by HoloDBS, then by SOC methods	Standard-of-care (SOC) surgery plan	HoloDBS hypothetical surgery plan is built before the standard-of-care (SOC) surgery plan
Surgery planning by HoloDBS, then by SOC methods	HoloDBS hypothetical surgery plan	HoloDBS hypothetical surgery plan is built before the standard-of-care (SOC) surgery plan

Primary Outcome Measures

Name	Time	Method
Difference between the actual post-operative location of the DBS electrode and the planned location.	1 month after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Number of physicians who reply 'yes' to the question, 'Was the additional data available in the HoloDBS application valuable in defining your theoretical optimal electrode position?'	6 months and 1 year after study starts	Open ended discussion with neurosurgery-neurology team

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States