Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus
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|ClinicalTrials.gov Identifier: NCT01721460|
Recruitment Status : Completed
First Posted : November 5, 2012
Results First Posted : November 6, 2017
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Deep Brain Stimulation Surgery||Drug: Dexmedetomidine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation Surgery|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Dexmedetomidine during MER
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.
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.
Other Name: Precedex
- Change in Average Population Spiking Activity [ Time Frame: 20-35 minutes following drug administration ]
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.
- Change in Average Firing Pattern in the STN [ Time Frame: 20-35 minutes following drug administration ]We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.
- Time to Recovery [ Time Frame: 20-60 minutes after stopping drug administration ]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 [ Time Frame: 30 minutes after stopping drug administration ]The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.
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): NCT01721460
|United States, Wisconsin|
|University of Wisconsin - Madison, School of Medicine and Public Health|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Aeyal Raz, MD, PhD||University of Wisconsin, Madison, Department of anesthesiology|