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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Matthew Brodsky, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01703598
First received: September 9, 2011
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ON time without dyskinesia [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in PDQ-39 [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in motor UPDRS [ Time Frame: Baseline and 6 months ]

Estimated Enrollment: 50
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT01703598

Contacts
Contact: Shannon Donovan, PA 503-494-7950 donovash@ohsu.edu

Locations
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

No publications provided

Responsible Party: Matthew Brodsky, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01703598     History of Changes
Other Study ID Numbers: IRB00007508
Study First Received: September 9, 2011
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014