Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation

NCT06191874 | Completed

• 2 other identifiers: Pro00113490R37NS116079
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Brain Stimulation

Keywords

DBS; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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; Other: HoloDBS hypothetical surgery plan

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; Other: HoloDBS hypothetical surgery plan

Interventions

Standard-of-care (SOC) surgery plan OTHER

Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery

Surgery planning by HoloDBS, then by SOC methods; Surgery planning by SOC methods, then by HoloDBS

HoloDBS hypothetical surgery plan OTHER

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; Surgery planning by SOC methods, then by HoloDBS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may not qualify if:

• 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).
• consideration of alternate diagnosis to Parkinson disease
• high risk medical comorbidities which would make the patient not a candidate for surgery.

Sponsors & Collaborators

• Duke University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 5, 2024
• Study Start: March 1, 2024
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: October 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)