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Completed

NCT Number: NCT01721460

Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Deep Brain Stimulation Surgery Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin - Madison, School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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 names: Precedex

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 5, 2012
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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