Back to resultsEffects of Dexmedetomidine on Activity in the Subthalamic Nucleus
Primary Purpose
Parkinson's Disease, Deep Brain Stimulation Surgery
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring SubThalamic Nucleus, Microelectrode recording, Deep Brain Stimulation Electrode implantation
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled to undergo bilateral STN electrode implantation surgery with Micro-electrode recording for the treatment of Parkinson's disease.
Exclusion Criteria:
- Hypersensitivity to dexmedetomidine
- Bradycardia: Sinus rhythm slower than 50 bpm
- Known or suspected obstructive sleep apnea
- Suspected difficult intubation
- Pregnancy
- Under 18 years of age or over 85 years of age
- Cognitive disability impairing understanding the experiment or signing the informed consent form
Sites / Locations
- University of Wisconsin - Madison, School of Medicine and Public Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dexmedetomidine during MER
Arm Description
The study is performed in patients undergoing DBS electrode implantation to their STN for the treatment of parkinson's disease. Microelectrode recording (MER) is performed as part of STN electrode implantation surgery, to increase the precision of the stimulating electrode placement. The study includes administration of dexmedetomidine while recording electrical activity at a single location to evaluate the effects of this drug on the MER.
Outcomes
Primary Outcome Measures
Change in Average Population Spiking Activity
We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation.
For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.
Secondary Outcome Measures
Change in Average Firing Pattern in the STN
We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.
Time to Recovery
The time it takes for the patient to become alert after drug administration is stopped.
Portion of Participants With Timely Return of the Neuronal Activity to Baseline
The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.
Full Information
NCT ID
NCT01721460
First Posted
October 30, 2012
Last Updated
November 6, 2017
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT01721460
Brief Title
Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus
Official Title
Effects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (STN).
Detailed Description
In order to find whether dexmedetomidine is optimal for sedation during Deep brain stimulation surgery, we will measure the electrical activity in the STN during Deep brain stimulation surgery, and measure how this activity is changed during administration of Dexmedetomidine. We hypothesize that dexmedetomidine does not change the firing rate and pattern in the STN.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Deep Brain Stimulation Surgery
Keywords
SubThalamic Nucleus, Microelectrode recording, Deep Brain Stimulation Electrode implantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine during MER
Arm Type
Experimental
Arm Description
The study is performed in patients undergoing DBS electrode implantation to their STN for the treatment of parkinson's disease. Microelectrode recording (MER) is performed as part of STN electrode implantation surgery, to increase the precision of the stimulating electrode placement. The study includes administration of dexmedetomidine while recording electrical activity at a single location to evaluate the effects of this drug on the MER.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.
Primary Outcome Measure Information:
Title
Change in Average Population Spiking Activity
Description
We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation.
For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units.
Time Frame
20-35 minutes following drug administration
Secondary Outcome Measure Information:
Title
Change in Average Firing Pattern in the STN
Description
We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.
Time Frame
20-35 minutes following drug administration
Title
Time to Recovery
Description
The time it takes for the patient to become alert after drug administration is stopped.
Time Frame
20-60 minutes after stopping drug administration
Title
Portion of Participants With Timely Return of the Neuronal Activity to Baseline
Description
The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.
Time Frame
30 minutes after stopping drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled to undergo bilateral STN electrode implantation surgery with Micro-electrode recording for the treatment of Parkinson's disease.
Exclusion Criteria:
Hypersensitivity to dexmedetomidine
Bradycardia: Sinus rhythm slower than 50 bpm
Known or suspected obstructive sleep apnea
Suspected difficult intubation
Pregnancy
Under 18 years of age or over 85 years of age
Cognitive disability impairing understanding the experiment or signing the informed consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aeyal Raz, MD, PhD
Organizational Affiliation
University of Wisconsin, Madison, Department of anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin - Madison, School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus
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