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: Completed
• Conditions: Deep Brain Stimulation
• Intervention / Treatment: Other: Standard-of-care (SOC) surgery plan; Other: HoloDBS hypothetical surgery plan

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Parkinson's disease scheduled for Deep Brain Stimulation Surgery

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?

Number of groups / cohorts

2

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	Other: Standard-of-care (SOC) surgery plan; Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery; Other: 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	Other: Standard-of-care (SOC) surgery plan; Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery; Other: HoloDBS hypothetical surgery plan; 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
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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): May 29, 2025
• Study Completion (Actual): May 29, 2025

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Parkinson's Disease; DBS
• 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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No