Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation
Evaluation of Advanced Imaging and Visualization to Clinical Deep Brain Stimulation
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27708
- Duke University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Surgery planning by SOC methods, then by HoloDBS
Standard-of-care (SOC) surgery plan is built before the HoloDBS hypothetical surgery plan
|
Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
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
|
Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
1 month after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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?'
Time Frame: 6 months and 1 year after study starts
|
Open-ended discussion with neurosurgery-neurology team.
Physicians were not considered enrolled.
|
6 months and 1 year after study starts
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Standard of Care
Other Study ID Numbers
- Pro00113490
- R37NS116079 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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