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Visualization of the STN and GPi for DBS

VISION · NCT05774041 · Run by Surgical Information Sciences Inc. · Record updated 2025. április 25.

Megadott ok: Study terminated by Sponsor

Where in Egyesült Államok

  • Boston · Beth Israel Deaconess Medical CenterIsmeretlen állapot
  • Durham · Duke UniversityIsmeretlen állapot
  • Hartford · Hartford HospitalIsmeretlen állapot
  • Hershey · Penn State UniversityIsmeretlen állapot
  • Iowa City · University of IowaIsmeretlen állapot
  • Little Rock · University of Arkansas for Medical SciencesIsmeretlen állapot
  • Miami · University of MiamiIsmeretlen állapot
  • Roanoke · Carilion ClinicIsmeretlen állapot
  • Tampa · University of South FloridaIsmeretlen állapot
  • Tucson · University of ArizonaIsmeretlen állapot
The registry text, word for word

Visualization of the STN and GPi for DBS Surgery in Patients With Parkinson's Disease

The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System.

Inclusion: Subject is diagnosed with Idiopathic Parkinson's Disease and is indicated for de novo DBS surgery with bilateral DBS leads implanted in the STN or GPi; Subject is 18 years or older; Subject must be able and willing to provide informed consent and comply with study follow-up schedule and procedures.

Exclusion: Subject had prior intracranial surgery or other implanted neurostimulators or drug delivery pumps; Subject is currently enrolled in another clinical study utilizing investigational medications, devices, or treatment that would conflict with this protocol; Subject is not a DBS surgical candidate due to untreated, clinically significant depression, current suicidal ideation, or dementia or any neuropsychological condition or finding that would contraindicate DBS surgery; Subject is Hoehn and Yahr stage 4-5 in the medication OFF condition; Subject's life expectancy is less than one year; Subject is pregnant or interested in becoming pregnant during the duration of the study.

ClinicalTrials.gov NCT05774041

Építés alatt, nem éles – Visualization of the STN and GPi for DBS (NCT05774041) – Frontlight Research