Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Oregon Health and Science University
Information provided by (Responsible Party):
Matthew Brodsky, Oregon Health and Science University Identifier:
First received: September 9, 2011
Last updated: March 28, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Parkinson's Disease
Device: Deep Brain Stimulation
Procedure: DBS surgery
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Outcomes of Deep Brain Stimulator Electrodes Placed Using Intraoperative Computed Tomography and Frameless Stereotaxis Versus Microelectrode Recording and Frame-based Stereotaxis

Resource links provided by NLM:

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Change in motor UPDRS in OFF Levodopa state [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures:
  • Change in PDQ-39 [ Time Frame: Baseline and 6 months ]
  • Change in ON time without dyskinesia- [ Time Frame: Baseline and 6 months ]
    based on motor diary

Estimated Enrollment: 32
Study Start Date: September 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DBS surgery
Single arm
Device: Deep Brain Stimulation
Placement of Deep Brain Stimulation electrodes
Procedure: DBS surgery
Placement of DBS electrodes

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01703598

Contact: Shannon Donovan, PA 503-494-7950

United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Matthew A Brodsky, MD         
Sub-Investigator: Kim Burchiel, MD         
Sub-Investigator: Shannon Donovan, PA         
Sub-Investigator: Joanna O'Leary, MD         
Sub-Investigator: David Gostnell, PhD         
Sponsors and Collaborators
Oregon Health and Science University
  More Information

Responsible Party: Matthew Brodsky, Principal Investigator, Oregon Health and Science University Identifier: NCT01703598     History of Changes
Other Study ID Numbers: IRB00007508
Study First Received: September 9, 2011
Last Updated: March 28, 2016

Keywords provided by Oregon Health and Science University:
Parkinson's disease
Deep Brain Stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases processed this record on April 28, 2017