Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation

Deep Brain Stimulation Clinical Trial

Official title:

Evaluation of Advanced Imaging and Visualization to Clinical Deep Brain Stimulation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06191874
• Other study ID #: Pro00113490
• Secondary ID: R37NS116079
• Status: Enrolling by invitation
• Start date: March 1, 2024
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Brain Stimulation

Intervention

Other:
• Standard-of-care (SOC) surgery plan
Use of SOC clinical planning tools to prepare for DBS (deep brain stimulation) surgery
• HoloDBS hypothetical surgery plan
Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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