N/A N=69 Treatment

Clinical Outcomes of Deep Brain Stimulator (DBS) Electrodes Placed Using Intraoperative Computed Tomography (CT) and Frameless Stereotaxis

Parkinson's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01703598 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Change in Motor OFF Ldopa UPDRS — 14.8 motor UPDRS

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Deep Brain Stimulation (Device); DBS surgery (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Oregon Health and Science University
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Motor OFF Ldopa UPDRS	14.8	—

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.

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.

View full record on ClinicalTrials.gov →

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.