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TerminatedNo phase

Visualization of the STN and GPi for DBS

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

Reason given: Study terminated by Sponsor

Where in United States

  • Boston · Beth Israel Deaconess Medical CenterUnknown status
  • Durham · Duke UniversityUnknown status
  • Hartford · Hartford HospitalUnknown status
  • Hershey · Penn State UniversityUnknown status
  • Iowa City · University of IowaUnknown status
  • Little Rock · University of Arkansas for Medical SciencesUnknown status
  • Miami · University of MiamiUnknown status
  • Roanoke · Carilion ClinicUnknown status
  • Tampa · University of South FloridaUnknown status
  • Tucson · University of ArizonaUnknown status
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