DBS Under General Anesthesia: Comparison To The Standard Technique

DBS Under General Anesthesia Without Neurophysiology: Initial Experience and Comparison To The Standard Technique

There is a growing trend in functional neurosurgery toward direct anatomical targeting for deep brain stimulation (DBS). This study describes a method and reports the initial experience placing DBS electrodes under general anesthesia without the use of microelectrode recordings (MER), using a portable head CT scanner to verify accuracy intra-operatively.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease

Detailed Description

Deep brain stimulation (DBS) is an established therapy for Parkinson's disease and tremor. The therapy was first introduced in the late 1980s, and was FDA approved in 1997. Over 100,000 patients have been treated with DBS, and the benefits have been confirmed through multicenter randomized controlled trials.

Traditional DBS is performed with the patient awake. Parkinson's patients are required to be off their Parkinson's medicine during awake DBS, and single-unit cellular recordings are performed to map the intended target. Electrophysiological mapping can require multiple brain penetrations. The surgery can last 4-6 hours. The surgeon uses a local anesthetic to numb the tissue where the incision is made, and mild sedatives are administered to ward off anxiety. The prospect of being awake on the operating table for brain surgery concerns some patients, as does the requirement to be off medicine.

There is growing interest in performing DBS under general anesthesia, whereby targets are selected anatomically (i.e., on MRI) rather than physiologically . So-called "asleep DBS" is performed with the patient under general anesthesia, and uses intraoperative CT imaging both to target and to verify accurate placement of DBS electrodes at the time of surgery. Asleep DBS eliminates the need for the patient to be kept awake and off medicine. The goal of Asleep DBS is to accurately place the electrodes at the target selected by the surgeon preoperatively, and this goal is accomplished through intraoperative imaging. Electrophysiological mapping is not performed.

The Asleep DBS program at Barrow Neurological Institute / SJHMC started in March 2012; the second institution world-wide to adopt the asleep technique developed by Dr. Kim Burchiel. Other institutions have performed asleep DBS within an MRI magnet to visualize the placement of the electrode. The "Burchiel technique" relies upon MRI-CT fusion algorithms to superimpose the leads, seen on CT, on the MRI which was used for planning.

While asleep DBS improves the patient experience, it is incumbent upon us to demonstrate that the functional outcomes are equivalent to those reported for traditional "awake" DBS. Further, despite common use of MRI-CT fusion, which is available on our neuronavigation systems, the evidence supporting this modality comes from the 1990s, primarily from Gamma Knife literature.

This study will include functional outcomes using established metrics for Parkinson's, capturing both motor function (Unified Parkinson's Disease Rating Scale) and quality of life (Parkinson's Disease Questionnaire-39). In addition, follow-up MRI imaging will allow us to verify that the true position of the DBS leads matches where we thought the leads were based on the intraoperative CT scan that was fused to the preoperative MRI. In other words, there is an error in placement that we see at the time of surgery (if we our inaccuracy is over 2 mm, we reposition the DBS lead). There is also an inherent inaccuracy with CT-MRI fusion. If these inaccuracies are compounded such that where we think we are at the time of surgery is far from where we actually are (as seen on the follow-up MRI of the brain), then CT-MRI fusion is not reliable and should not be used to verify lead placement.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospiatl & Medical Center / Barrow Neurological Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected by CPT codes corresponding to bilateral DBS electrode placement placed under general anesthesia with Leksell sterotactic navigation, portable CT and without the use of microelectrode recordings (MER).

Description

Inclusion Criteria:

• Patient's who have undergone DBS surgery under general anesthesia without electrophysiology, utilizing a portable head CT scanner to verify accuracy intra-operatively.

Exclusion Criteria:

• Patient's who have undergone DBS surgery awake, without general anesthesia and with electrophysiology.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"Off" and "On" Medication Unified Parkinson's Disease Rating III Score (UPDRS)	A movement disorders clinician who had completed the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) training performed prospective baseline and 6-month postoperative assessments of motor function using the MDS modified UPDRS III on patients during both off-medication (PD medications held for 12 h) and on-medication states. UPDRS III motor scores range from 0 (no motor function deficit) to 132 (highest motor function deficit). There were no subscales.	pre-operatively and 6 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parkinson's Disease Quality-39 Score (PDQ-39)	Effects on PDQ-39 scores 6 months following asleep DBS surgery as compared to pre-operative scores. Data from the PDQ-39 can be presented either subset scores or as a single total score. PDQ-39 measures patient quality of life indicators including mobility, activities of daily living, emotional well being, stigma, communication and bodily discomfort. Data from the PDQ-39 can be presented in either subset scores or as a single total score. The full range of the total PDQ-39 scores is from 0 ( no patient related symptoms, or quality of life unaffected) to 156 ( relates having symptoms ", or low quality of life). The subset score ranges are as follows: mobility: 0 (no patient related symptoms) to 40 (highest patient related symptoms). activities of daily living: 0 to 24; emotional well being: 0-24; stigma: 0-16; cognition: 0-16; communication: 0-12; bodily discomfort: 0-12.	pre-operatively and 6 months post-operatively

Collaborators and Investigators

• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Investigators: Principal Investigator: Francisco A Ponce, MD, BARROW NEUROLOGICAL INSTITUTE / SJHMC

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (ESTIMATE): November 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Deep brain stimulation surgery under general anesthesia; Deep brain stimulation target accuracy; Deep brain stimulation for Parkinsons's disease; Deep brain stimulation functional outcomes; Deep brain stimulation quality of life outcomes
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 12BN123