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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01703598
First Posted: October 10, 2012
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matthew Brodsky, Oregon Health and Science University
  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
Parkinson's Disease Device: Deep Brain Stimulation Procedure: DBS surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Asleep Deep Brain Stimulation
Masking: None (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 Matthew Brodsky, 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


Enrollment: 32
Study Start Date: September 2011
Study Completion Date: March 2017
Primary Completion Date: March 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703598


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
  More Information

Responsible Party: Matthew Brodsky, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01703598     History of Changes
Other Study ID Numbers: IRB00007508
First Submitted: September 9, 2011
First Posted: October 10, 2012
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by Matthew Brodsky, 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