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

July 23, 2019 updated by: Matthew Brodsky, Oregon Health and Science University

Clinical Outcomes of Deep Brain Stimulator Electrodes Placed Using Intraoperative Computed Tomography and Frameless Stereotaxis Versus Microelectrode Recording and Frame-based Stereotaxis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Frame-based stereotaxis and microelectrode recording (MER) with mapping of target structures has been the gold standard for deep brain stimulator (DBS) implantation. Though supported by historical considerations, no Class I or II evidence exists that MER adds significant value to the DBS implant procedure. With the advent of advanced magnetic resonance imaging (MRI) and computed tomography (CT) imaging, particularly intra-operative imaging, the argument for the continued use of MER during DBS implantation has been substantially weakened. One rationale for pursuing CT-guided intraoperative imaging is due to presumed increase in patient comfort with this method. DBS implantation with MER requires that the patient remain awake during the entire procedure. , MER with frame-based stereotaxis requires the patient to keep their head in a fixed position for a prolonged period of time during which time they remain awake, causing significant patient discomfort. Furthermore, Parkinson's disease patients must withhold their PD meds for a minimum of 12 hours prior to the procedure adding a sometimes significant degree of discomfort and anxiety to the procedure.

Objective: The goal of this study is to compare the clinical outcomes of DBS electrodes placed using intraoperative CT and frameless stereotaxis with those placed using MER and frame-based stereotaxis.

Design: The proposed study will be a prospective non-interventional data collection study.

Setting and Subjects: Subjects for this study will be idiopathic Parkinson's disease patients identified from the Oregon Health & Science University movement disorder clinic as candidates for deep brain stimulation therapy. Enrollment will continue until fifty subjects have been implanted with electrodes using frameless stereotaxis and intraoperative CT. Data regarding quality of life, motor control, and amount of time during the day without levodopa side effects will be collected pre-operatively and post-operatively. This data will be compared to historical controls who have been implanted with DBS electrodes using MER and frame-based stereotaxis. All surgical procedures will involve only Federal Drug Administration (FDA) approved stereotactic equipment, used in the manner for which they have been approved. All clinic procedures are standard of care for movement disorders patients in the deep brain stimulation program.

Intervention: This study will be a non-interventional data collection study.

Measurements: Data regarding patient age, diagnosis, intracranial target, complications, Unified Parkinson's Disease Rating Scale UPDRS Parts 3 (motor examination) and 4 (drug side effects), Parkinson's Disease Quality of life PDQ-39, 3 day motor diary, 3 month falls diary, neuropsychiatric evaluation and days in hospital following surgery will be collected.

Analysis: The patients will be examined prior to DBS placement both on and off dopaminergic medications. They will then be examined 3 months and 6 months following DBS placement both on and off drug with stimulator on after programming parameters have been optimized. The following measures will be performed:

  • Change in UPDRS Parts 3 and 4
  • Change in PDQ-39
  • Change in amount of time patient is experiencing Parkinson's disease symptoms and/or side effects of treatment.
  • Change in number of falls
  • Change in neuropsychiatric evaluation, including:
  • Beck Depression Inventory-II (BDI-II)
  • Mattis Dementia Rating Scale-Second Edition (DRS-2)
  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
  • Symptom Checklist-90-Revised (SCL-90-R)
  • Wechsler Abbreviated Scale of Intelligence (WASI) We will also compare the number of days spent in hospital following surgery. Adverse events related to the surgery will be captured.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DBS surgery
Single arm
Device: Deep Brain Stimulation
Placement of Deep Brain Stimulation electrodes
Procedure: DBS surgery
Placement of DBS electrodes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Motor OFF Ldopa UPDRS
Time Frame: Baseline and 6 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

September 9, 2011

First Submitted That Met QC Criteria

October 9, 2012

First Posted (ESTIMATE)

October 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00007508

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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