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| ID | Type | Description | Link |
|---|---|---|---|
| R37NS116079 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery planning by SOC methods, then by HoloDBS | Standard-of-care (SOC) surgery plan is built before the HoloDBS hypothetical surgery plan |
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| Surgery planning by HoloDBS, then by SOC methods | HoloDBS hypothetical surgery plan is built before the standard-of-care (SOC) surgery plan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard-of-care (SOC) surgery plan | Other | Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference between the actual post-operative location of the DBS electrode and the planned location. | 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. | 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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?' | Open ended discussion with neurosurgery-neurology team | 6 months and 1 year after study starts |
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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:
Exclusion criteria:
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Patients with Parkinson's disease scheduled for Deep Brain Stimulation Surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27708 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 14, 2026 | |
| Reset | Jun 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 14, 2026 | Jun 9, 2026 | |||
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| HoloDBS hypothetical surgery plan | Other | Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |