Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus

Phase 4

Completed

• Conditions: Parkinson's Disease; Deep Brain Stimulation Surgery
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT01721460
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study First Submitted: 2012-10-30
• Study Start: 2012-11
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2017-06-01
• Results First Submitted QC: 2017-10-02
• Status Verified: 2017-11
• Results First Posted: 2017-11-06
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine during MER	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Change in Average Population Spiking Activity	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.

Secondary Outcome Measures

Name	Time	Method
Change in Average Firing Pattern in the STN	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	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	30 minutes after stopping drug administration	The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.

Trial Locations

Locations (1)

University of Wisconsin - Madison, School of Medicine and Public Health; 🇺🇸 Madison, Wisconsin, United States