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NCT06191874Completed

Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation

Evaluation of Advanced Imaging and Visualization to Clinical Deep Brain Stimulation

Source: ClinicalTrials.gov · Last updated 24 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
22 (actual)
First submitted
6 Dec 2023
Start date
1 Mar 2024
Primary completion date
29 May 2025
Lead sponsor
Duke University
NCT number
NCT06191874

What you commit to

  • Study type: Observational
  • Participants enrolled: 22
  • From 1 Mar 2024 to the primary completion date, 29 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • high risk medical comorbidities which would make the patient not a candidate for surgery.

Other illness

  • consideration of alternate diagnosis to Parkinson disease

Who the study is looking for

  • 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).

Criteria the registry did not label

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke University
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.