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Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: October 30, 2012
Last updated: October 9, 2015
Last verified: October 2015

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

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.

Condition Intervention Phase
Parkinson's Disease
Deep Brain Stimulation Surgery
Drug: Dexmedetomidine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation Electrode Implantation Surgery

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in average firing rate and pattern in the STN [ Time Frame: 20-35 minutes following drug administration ] [ Designated as safety issue: No ]
    We will calculate the root mean square (RMS) of the electrical activity as a measure of the spiking rate of neurons in the vicinity of the electrode tip.

Secondary Outcome Measures:
  • Time to achieve optimal sedation [ Time Frame: 20-35 minutes following drug administration ] [ Designated as safety issue: No ]
  • Time to recovery [ Time Frame: 20-35 minutes following drug administration ] [ Designated as safety issue: No ]
    Time it takes for the patient to become alert after drug administration is stopped.

  • Time to recovery of the neuronal activity [ Time Frame: 20-35 minutes following drug administration ] [ Designated as safety issue: No ]
    Only if the drug actually change the neuronal activity.

Estimated Enrollment: 24
Study Start Date: November 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Administration of dexmedetomidine during the Microelectrode recording part of STN electrode implantation surgery.
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.
Other Name: Precedex


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01721460

United States, Wisconsin
University of Wisconsin - Madison, School of Medicine and Public Health
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Aeyal Raz, MD, PhD University of Wisconsin, Madison, Department of anesthesiology
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT01721460     History of Changes
Other Study ID Numbers: 2012-0400 
Study First Received: October 30, 2012
Last Updated: October 9, 2015
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board
United States: Federal Government
United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
SubThalamic Nucleus
Microelectrode recording
Deep Brain Stimulation Electrode implantation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016