N/A
Completed N=69
Clinical Outcomes of Deep Brain Stimulator (DBS) Electrodes Placed Using Intraoperative Computed Tomography (CT) and Frameless Stereotaxis
Source: ClinicalTrials.gov NCT01703598 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Change in Motor OFF Ldopa UPDRS — 14.8 motor UPDRS
Summary
The purpose of this study is to determine whether performing deep brain stimulation surgery for Parkinson's disease using intraoperative imaging and frameless stereotaxis is noninferior to using frame-based stereotaxy and microelectrode recording.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Motor OFF Ldopa UPDRS |
14.8 | — |
Eligibility Criteria
Inclusion Criteria
- Idiopathic Parkinson's disease patients identified by OHSU movement disorders neurologists as deep brain stimulation surgical candidates
Exclusion Criteria
- Subjects who have already undergone implantation of DBS electrodes 2.Age < - - 18 years
- Surgical target site other than subthalamic nucleus or globus pallidus pars interna
- Subjects who choose to undergo MER and frame-based stereotaxis for the placement of electrodes.
- Patients who will receive follow up neurology care and DBS programming at centers other than OHSU.
Data sourced from ClinicalTrials.gov (NCT01703598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.