Trial Comparing Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Parkinson's Disease

September 27, 2021 updated by: St. Joseph's Hospital and Medical Center, Phoenix

Randomized Controlled Clinical Trial Comparing Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Parkinson's Disease

The purpose of the proposed study is to demonstrate that the functional outcomes of DBS surgery utilizing the "asleep" technique are not inferior to those reported for traditional "awake" DBS technique.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Traditional DBS is performed without general anesthesia with the patient awake. Local anesthetic is used to numb the skin and tissue where the incision is made, and the patients are given mild sedatives to alleviate anxiety and discomfort. Parkinson's patients need to be off their medications during awake DBS in order to obtain single-unit cellular recordings to locate and map the desired target. The process of electrophysiological mapping can result in multiple brain penetrations during lead placement, and the entire procedure may last anywhere from 4-6 hours on average. The concept of being awake during brain surgery and being off medications are significant concerns for some patients. In addition, it is widely recognized that microelectrode recording increases the risk of hemorrhage during DBS surgery.

Recently, there has been increasing interest in performing DBS under general anesthesia, where the stimulated targets are located anatomically (i.e. on MRI) rather than physiologically via microelectrode recordings. This technology has been termed "asleep" DBS and is performed with the patient under general anesthesia. Intraoperative imaging is utilized to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery. Because stereotactic accuracy (and surgical safety) is the surgical endpoint, there is no need for the patient to be off medication and awake during the procedure.

Traditional DBS is performed without general anesthesia with the patient awake. Local anesthetic is used to numb the skin and tissue where the incision is made, and the patients are given mild sedatives to alleviate anxiety and discomfort. Parkinson's patients need to be off their medications during awake DBS in order to obtain single-unit cellular recordings to locate and map the desired target. The process of electrophysiological mapping can result in multiple brain penetrations during lead placement, and the entire procedure may last anywhere from 4-6 hours on average. The concept of being awake during brain surgery and being off medications are significant concerns for some patients. In addition, it is widely recognized that microelectrode recording increases the risk of hemorrhage during DBS surgery.

The safety and efficacy of the two approaches to DBS surgery have been equivalent, and we are at a position of equipoise with regard to what to offer to patients. To date, there have been no randomized, controlled clinical trials comparing the efficacy and functional outcomes of the two DBS methods. After informed consent is obtained, the patients will undergo routine DBS pre-operative evaluation and diagnostic testing. This includes a pre-operative 3T-MRI with and without gadolinium as well as pre-operative medical clearance by the patient's PCP or general practitioner and/or other medical specialist if necessary. They will also receive a baseline clinical evaluation including both motor function (Unified Parkinson's Disease Rating Scale on and off antiparkinsonian medication) and quality of life (Parkinson's disease Questionnaire-39) if not already completed as part of the routine DBS candidacy evaluation within 2 months of surgery. Patients who elect to participate in this trial will undergo a routine pre-operative neurocognitive evaluation consisting of the following routine evaluative tests: Wechsler Test of Adult Reading, Mattis Dementia Rating Scale 2nd Edition, Wechsler Abbreviate Scale of Intelligence 2nd Edition; Wechsler Memory Scale 3rd edition, Digit Span, Stroop Neuropsychological Screening Test, Trail Making Test, Wisconsin Card Sorting Test, Controlled Oral Word Association Test, Animal Naming, Boston Naming Test, Wechsler Memory Scale 4th Edition, Logical Memory, Hopkins Verbal Learning Test - Revised, Brief Visuospatial Memory Test - Revised, Hooper visual Organization Test, Judgment of Line Orientation, Beck Depression Inventory, Beck Anxiety Inventory, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease, Apathy Evaluation Scale; Epworth Sleepiness Scale, The subjects will then be randomized to 2 groups by using random numbers in an envelope system. We anticipate that 120 total patients will need to be enrolled in this pilot study (60 awake, 60 asleep), and thus the numbers 1-120 will be placed in envelopes. An odd number will correspond to the awake DBS procedure, and an even number will indicate an asleep DBS procedure.

The purpose of the proposed study is to demonstrate that the functional outcomes of the "asleep" technique are not inferior to those reported for traditional "awake" DBS technique. The primary data points for this study will include six month functional outcomes using accepted metrics for Parkinson's disease, including both motor function (Unified Parkinson's Disease Rating Scale [UPDRS] obtained in the medication "on" and medication "off" states) and quality of life (Parkinson's Disease Questionnaire-39). The null hypothesis is that asleep DBS results in inferior UPDRS-III scores at 6-months after surgery. Our secondary aim will be to evaluate any cognitive changes associated with DBS surgery selection (awake vs. asleep) in PD patients. Current standard of care for patient selection in DBS focuses primarily on the evaluation of motor symptoms and currently there is no guidance for how a patients' DBS surgery selection (awake vs. asleep) would impact on subsequent neurocognitive function.

Study Type

Interventional

Enrollment (Actual)

1

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

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parkinson's disease per Queens Square criteria
  • Appropriate DBS candidate for multi-disciplinary team consensus
  • Age 18 - 85 years of age
  • Motor skills allowing for capability to complete evaluations
  • Medically cleared for undergoing anesthesia and DBS surgery

Exclusion Criteria:

  • Dementia per DSM-V criteria
  • Medical or other condition precluding MRI
  • History of supraspinal CNS disease other than PD
  • Alcohol use of more than 4 drinks per day
  • Pregnancy
  • History of suicide attempt
  • Currently uncontrolled clinically significant depression (BDI>20)
  • History of schizophrenia, delusions, or currently uncontrolled visual hallucinations

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Awake DBS Surgery
Deep brain stimulation surgery: Parkinson's patients undergoing traditional "awake" DBS surgery utilizing microelectrode recordings and intra-operative stimulation
Procedure: Deep Brain Stimulation surgery
Deep Brain Stimulation surgery: awake vs. asleep
Other Names:
  • DBS
Active Comparator: Asleep DBS Surgery
Deep brain stimulation surgery:Parkinson's patients undergoing DBS surgery under general anesthesia utilizing intraoperative imaging to verify the stereotactic accuracy of DBS electrodes placement at the time of surgery.
Procedure: Deep Brain Stimulation surgery
Deep Brain Stimulation surgery: awake vs. asleep
Other Names:
  • DBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcomes
Time Frame: 6 months post-operatively

Motor function outcomes using accepted metrics for Parkinson's disease - the Unified Parkinson's Disease Rating Scale [UPDRS] obtained in 3 states:

  1. medication "off" / device "on".
  2. Medication "off" / device "off"
  3. medication "on" / device "on"
6 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive Function
Time Frame: 6 months post-operatively
Neurocognitive evaluation consisting of the following routine evaluative tests: Wechsler Test of Adult Reading, Mattis Dementia Rating Scale 2nd Edition, Wechsler Abbreviate Scale of Intelligence 2nd Edition; Wechsler Memory Scale 3rd edition, Digit Span, Stroop Neuropsychological Screening Test, Trail Making Test, Wisconsin Card Sorting Test, Controlled Oral Word Association Test, Animal Naming, Boston Naming Test, Wechsler Memory Scale 4th Edition, Logical Memory, Hopkins Verbal Learning Test - Revised, Brief Visuospatial Memory Test - Revised, Hooper visual Organization Test, Judgment of Line Orientation, Beck Depression Inventory, Beck Anxiety Inventory, Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease, Apathy Evaluation Scale; Epworth Sleepiness Scale.
6 months post-operatively
Quality of Life
Time Frame: 6 months post-operatively
Parkinson's Disease Questionnaire-39 to evaluate the patient's assessment of their quality of life following DBS surgery
6 months post-operatively

Collaborators and Investigators

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

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Investigators

  • Principal Investigator: Francisco A Ponce, MD, Barrow Neurological Institute / St. Joseph's Hosptial and Medical Center

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 (Actual)

January 15, 2015

Primary Completion (Actual)

October 5, 2015

Study Completion (Actual)

October 5, 2015

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB # 14BN147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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