Deep Brain Stimulation
Conditions
Keywords
DBS, Parkinson's Disease
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.
Interventions
OTHERStandard-of-care (SOC) surgery plan
Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
OTHERHoloDBS hypothetical surgery plan
Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery
Sponsors
Duke University
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Electronic medical records (EMR) from all patients undergoing preoperative DBS evaluation will be reviewed and their data will be used for this study's purposes if they fit the inclusion and
Exclusion criteria
. Inclusion criteria: * age 18 years and over * meeting qualification for deep brain stimulation for Parkinson's disease with one or more of medication refractory tremor, motor fluctuations despite medication optimization, or levodopa responsiveness but limited by medication induced adverse effects (nausea, dystonia, dyskinesia for example).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance 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. 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 and 1 year after study starts | Open-ended discussion with neurosurgery-neurology team. Physicians were not considered enrolled. |
Countries
United States
Participant flow
Pre-assignment details
Two participants were excluded from the study as they opted not to have DBS (Deep Brain Stimulation) surgery.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
None listed