Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
Primary Purpose
Parkinson's Disease, Essential Tremor, Dystonia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine Hydrochloride Infusion
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Any patient who has agreed to undergo DBS implantation.
Exclusion Criteria:
- Patients who fail recommendation for DBS surgery discussed in Vanderbilt University Movement Disorder Clinical Conference.
- Patients not consented for DBS surgery.
- Patients or legal guardians not able to provide informed consent.
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
PD-STN
PD - GPi
ET - VIM
Dystonia - GPi
PD - STN Control
PD - GPi Control
ET - VIM Control
Dystonia - GPi Control
Arm Description
Parkinson's Disease -- STN target
Parkinson's Disease -- GPi target
Essential Tremor -- VIM target
Dystonia -- GPi target
Parkinson's Disease -- STN target
Parkinson's Disease -- GPi target
Essential Tremor -- VIM target
Dystonia -- GPi target
Outcomes
Primary Outcome Measures
Micro-electrode Recordings
Secondary Outcome Measures
Neurological Exam Findings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00608231
Brief Title
Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
Official Title
Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Intraoperative recording could not be maintained for required period
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings
Detailed Description
Deep brain stimulator (DBS) implants are used in the treatment of medically refractory movement disorders such as Parkinson's disease, essential tremor and dystonia. Because of the uniqueness of each individual brain, the surgery to implant a DBS electrode requires detailed anatomic and physiological information for each patient. The anatomic data is obtained before surgery via a Magnetic Resonance Imaging (MRI) scan of the patient's brain. Physiological data is obtained during the operation via micro-electrode recording of the patient's brain and neurological examination of the patient. Therefore, DBS surgery can be uncomfortable to patients, as it can be very time consuming and requires the patient to be awake and attentive.
The specific aims of this project are:
To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings.
To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery have no significant effects on neurological findings and/or patient cooperation during neurological examination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Essential Tremor, Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PD-STN
Arm Type
Experimental
Arm Description
Parkinson's Disease -- STN target
Arm Title
PD - GPi
Arm Type
Experimental
Arm Description
Parkinson's Disease -- GPi target
Arm Title
ET - VIM
Arm Type
Experimental
Arm Description
Essential Tremor -- VIM target
Arm Title
Dystonia - GPi
Arm Type
Experimental
Arm Description
Dystonia -- GPi target
Arm Title
PD - STN Control
Arm Type
Placebo Comparator
Arm Description
Parkinson's Disease -- STN target
Arm Title
PD - GPi Control
Arm Type
Placebo Comparator
Arm Description
Parkinson's Disease -- GPi target
Arm Title
ET - VIM Control
Arm Type
Placebo Comparator
Arm Description
Essential Tremor -- VIM target
Arm Title
Dystonia - GPi Control
Arm Type
Placebo Comparator
Arm Description
Dystonia -- GPi target
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride Infusion
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine Hydrochloride Infusion(0.5-1.0 mg/kg)intravenous over 10 minutes with dose adjustment for goal Richmond Agitation and Sedation Scale of -1 During deep brain stimulator implantation surgery
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Placebo control
Intervention Description
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Primary Outcome Measure Information:
Title
Micro-electrode Recordings
Time Frame
Intra-operative
Secondary Outcome Measure Information:
Title
Neurological Exam Findings
Time Frame
Intra-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient who has agreed to undergo DBS implantation.
Exclusion Criteria:
Patients who fail recommendation for DBS surgery discussed in Vanderbilt University Movement Disorder Clinical Conference.
Patients not consented for DBS surgery.
Patients or legal guardians not able to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Neimat, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
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