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Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Essential Tremor

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.
 
ClinicalTrials.gov Identifier: NCT02418858
Recruitment Status : Withdrawn (Lack of subject enrollment)
First Posted : April 16, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Brief Summary:
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 and intra-operative test stimulation. 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 awake during the procedure.

Condition or disease Intervention/treatment Phase
Essential Tremor Procedure: Deep Brain Stimulation surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial Comparing Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Essential Tremor
Study Start Date : February 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Active Comparator: Awake DBS Surgery
Deep brain stimulation surgery: Essential tremor patients undergoing traditional "awake" DBS surgery utilizing microelectrode recordings and intraoperative stimulation.
Procedure: Deep Brain Stimulation surgery
Deep Brain Stimulation surgery awake vs. asleep
Other Name: DBS

Active Comparator: Asleep DBS Surgery
Deep brain stimulation surgery: Essential tremor patients undergoing DBS surgery under general anesthesia utilizing intraoperative imaging to verify the stereotactic accuracy of DBS electrode placement at the time of surgery.
Procedure: Deep Brain Stimulation surgery
Deep Brain Stimulation surgery awake vs. asleep
Other Name: DBS




Primary Outcome Measures :
  1. Functional Outcomes [ Time Frame: 12 weeks post-operatively ]
    The primary data points for this study will include three month functional outcomes using accepted outcome metrics for ET, including an objective tremor rating scale (Fahn-Tolosa-Marin Tremor Rating Scale), a tremor ADL questionnaire (Bain and Findley Tremor ADL scale) for comparison to preoperative scores.

  2. Quality of Life Assessment [ Time Frame: 12 week post-operatively ]
    Quality of life in Essential Tremor [QUEST] questionnaire will be collected again for comparison to preoperative scores.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Tremor Reduction [ Time Frame: 12 weeks post-operatively ]
    Parkinson Meter and Life Pulse tremor readings will be collected for comparison to preoperative scores.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Essential Tremor diagnosed by criteria listed in the Consensus statement of the Movement Disorders Society on Tremor
  • 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 Essential Tremor
  • 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

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): NCT02418858


Locations
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United States, Arizona
Barrow Neurological Institute / St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
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Principal Investigator: Francisco A Ponce, MD Barrow Neurological Institute / St. Joseph's Hospital and Medical Center
Publications:

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Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT02418858    
Other Study ID Numbers: IRB # 14BN146
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015
Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
Essential tremor
DBS
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases