Trial Outcomes & Findings for Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation (NCT NCT06191874)
NCT ID: NCT06191874
Last Updated: 2026-07-24
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
22 participants
Primary outcome timeframe
1 month after surgery
Results posted on
2026-07-24
Participant Flow
Two participants were excluded from the study as they opted not to have DBS (Deep Brain Stimulation) surgery.
Participant milestones
| Measure |
Surgery Planning by SOC Methods, Then by HoloDBS
Standard-of-care (SOC) surgery plan is built before the HoloDBS hypothetical surgery plan
Standard-of-care (SOC) surgery plan: Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
HoloDBS hypothetical surgery plan: Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery
|
Surgery Planning by HoloDBS, Then by SOC Methods
HoloDBS hypothetical surgery plan is built before the standard-of-care (SOC) surgery plan
Standard-of-care (SOC) surgery plan: Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
HoloDBS hypothetical surgery plan: Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation
Baseline characteristics by cohort
| Measure |
Surgery Planning by SOC Methods, Then by HoloDBS
n=10 Participants
Standard-of-care (SOC) surgery plan is built before the HoloDBS hypothetical surgery plan
Standard-of-care (SOC) surgery plan: Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
HoloDBS hypothetical surgery plan: Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery
|
Surgery Planning by HoloDBS, Then by SOC Methods
n=10 Participants
HoloDBS hypothetical surgery plan is built before the standard-of-care (SOC) surgery plan
Standard-of-care (SOC) surgery plan: Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
HoloDBS hypothetical surgery plan: Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 5.3 • n=9 Participants
|
61.8 years
STANDARD_DEVIATION 10.8 • n=27 Participants
|
64.9 years
STANDARD_DEVIATION 8.9 • n=267 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 1 month after surgeryComparison 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).
Outcome measures
| Measure |
Surgery Planning by SOC Methods, Then by HoloDBS
n=10 Participants
Standard-of-care (SOC) surgery plan is built before the HoloDBS hypothetical surgery plan
Standard-of-care (SOC) surgery plan: Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
HoloDBS hypothetical surgery plan: Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery
|
Surgery Planning by HoloDBS, Then by SOC Methods
n=10 Participants
HoloDBS hypothetical surgery plan is built before the standard-of-care (SOC) surgery plan
Standard-of-care (SOC) surgery plan: Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
HoloDBS hypothetical surgery plan: Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery
|
|---|---|---|
|
Distance Between the Actual Post-operative Location of the DBS Electrode and the Planned Location
Standard-of-care (SOC)
|
2.44 mm
Standard Deviation 0.90
|
2.85 mm
Standard Deviation 1.94
|
|
Distance Between the Actual Post-operative Location of the DBS Electrode and the Planned Location
HoloDBS
|
1.99 mm
Standard Deviation 0.86
|
1.82 mm
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: 6 months and 1 year after study startsOpen-ended discussion with neurosurgery-neurology team. Physicians were not considered enrolled.
Outcome measures
| Measure |
Surgery Planning by SOC Methods, Then by HoloDBS
n=10 Participants
Standard-of-care (SOC) surgery plan is built before the HoloDBS hypothetical surgery plan
Standard-of-care (SOC) surgery plan: Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
HoloDBS hypothetical surgery plan: Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery
|
Surgery Planning by HoloDBS, Then by SOC Methods
n=10 Participants
HoloDBS hypothetical surgery plan is built before the standard-of-care (SOC) surgery plan
Standard-of-care (SOC) surgery plan: Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
HoloDBS hypothetical surgery plan: Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery
|
|---|---|---|
|
Percentage 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
|
100 percentage of physicians
|
100 percentage of physicians
|
|
Percentage 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?'
1 year
|
100 percentage of physicians
|
100 percentage of physicians
|
Adverse Events
Surgery Planning by SOC Methods, Then by HoloDBS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Surgery Planning by HoloDBS, Then by SOC Methods
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place