Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus

Parkinson's Disease Clinical Trial

Official title:

Effects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721460
• Other study ID #: 2012-0400
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2012
• Last updated: November 6, 2017
• Start date: November 2012
• Est. completion date: June 2015

Study information

• Verified date: November 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (STN).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Brain Stimulation Surgery
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Dexmedetomidine
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.

Locations

Country	Name	City	State
United States	University of Wisconsin - Madison, School of Medicine and Public Health	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20-35 minutes following drug administration
Secondary	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.	20-35 minutes following drug administration
Secondary	Time to Recovery	The time it takes for the patient to become alert after drug administration is stopped.	20-60 minutes after stopping drug administration
Secondary	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.	30 minutes after stopping drug administration