Status:

COMPLETED

Evaluation of Advanced Imaging and Visualization for Clinical Deep Brain Stimulation

Lead Sponsor:

Duke University

Collaborating Sponsors:

National Institute of Neurological Disorders and Stroke (NINDS)

Conditions:

Deep Brain Stimulation

Eligibility:

All Genders

18+ years

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 H...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2024

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    May 29 2025

    Estimated Enrollment :

    20 Patients enrolled

    Trial Details

    Trial ID

    NCT06191874

    Start Date

    March 1 2024

    End Date

    May 29 2025

    Last Update

    October 24 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Duke University

    Durham, North Carolina, United States, 27708