AzTrials
AzTrials

Parkinson's DiseaseNCT01997398

DBS Under General Anesthesia: Comparison To The Standard Technique

An observational study of Parkinson's Disease, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson's Disease
How many people
35 participants
Where
1 siteUnited States
Study dates
Nov 2012to Jan 2015
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • St. Joseph's Hospiatl & Medical Center / Barrow Neurological Institute

    Phoenix, Arizona, 85013

Other trials in United States

About this study

Official title: 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.

Read the 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.

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
Medical subject headings
Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. "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.

    Measured: pre-operatively and 6 months post-operatively

Secondary outcomes (1)
  1. 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.

    Measured: pre-operatively and 6 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2013 (estimated)
  2. Study startNov 2012
  3. Primary completionDec 2014
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01997398
Sponsor's protocol ID
12BN123
Status last verified
Dec 2015
First submitted
18 Nov 2013
Last updated
1 Jan 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

"Off" and "On" Medication Unified Parkinson's Disease Rating III Score (UPDRS) (time frame: pre-operatively and 6 months post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT01997398 | AzTrials