Clinical Outcomes of Deep Brain Stimulator (DBS) Electrodes Placed Using Intraoperative Computed Tomography (CT) and Frameless Stereotaxis
1 other identifier
interventional
69
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 9, 2011
CompletedFirst Posted
Study publicly available on registry
October 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedResults Posted
Study results publicly available
August 13, 2019
CompletedAugust 13, 2019
July 1, 2019
5.5 years
September 9, 2011
June 20, 2019
July 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Motor OFF Ldopa UPDRS
Change in motor UPDRS in OFF Levodopa state. The range of this outcome is from 0 to 108, a higher number indicated a worse clinical state. The number represents units on this scale.
Baseline and 6 months
Study Arms (1)
DBS surgery
EXPERIMENTALSingle arm
Interventions
Eligibility Criteria
You may qualify if:
- Idiopathic Parkinson's disease patients identified by OHSU movement disorders neurologists as deep brain stimulation surgical candidates
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
Related Publications (1)
Brodsky MA, Anderson S, Murchison C, Seier M, Wilhelm J, Vederman A, Burchiel KJ. Clinical outcomes of asleep vs awake deep brain stimulation for Parkinson disease. Neurology. 2017 Nov 7;89(19):1944-1950. doi: 10.1212/WNL.0000000000004630. Epub 2017 Oct 6.
PMID: 28986415DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Matthew Brodsky MD
- Organization
- Oregon Health & Science University
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Brodsky, MD
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 9, 2011
First Posted
October 10, 2012
Study Start
September 1, 2011
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
August 13, 2019
Results First Posted
August 13, 2019
Record last verified: 2019-07