Skip to main content
OpenTrials
Completed

NCT Number: NCT06191874

Evaluation of Advanced Imaging and Visualization for 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deep Brain Stimulation Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27708, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard-of-care (SOC) surgery plan

Other

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

HoloDBS hypothetical surgery plan

Other

Use of next generation visualization tools and surgical targeting models to hypothetically prepare for DBS (deep brain stimulation) surgery

Primary outcomes

  1. Distance Between the Actual Post-operative Location of the DBS Electrode and the Planned Location

    Time frame: 1 month after surgery

    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. The distance was calculated for each hemisphere for each participant as the distance between the actual post-operative electrode location and the location defined in the SOC plan (indicated as SOC) and the distance between the actual post-operative electrode location and the location defined in the HoloDBS plan (indicated as HoloDBS).

Secondary outcomes

  1. Percentage 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?'

    Time frame: 6 months and 1 year after study starts

    Open-ended discussion with neurosurgery-neurology team. Physicians were not considered enrolled.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Evaluation of Advanced Imaging and Visualization to Clinical Deep Brain Stimulation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.