Evaluation of Advanced Imaging and Visualization to Clinical Deep Brain Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Difference between the actual post-operative location of the DBS electrode and the planned location.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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).
- •Exclusion criteria:
- •consideration of alternate diagnosis to Parkinson disease
- •high risk medical comorbidities which would make the patient not a candidate for surgery.
Outcomes
Primary Outcomes
Difference between the actual post-operative location of the DBS electrode and the planned location.
Time Frame: 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.
Distance Between the Actual Post-operative Location of the DBS Electrode and the Planned Location
Time Frame: 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 Outcomes
- 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)
- 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)