Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01721460
First received: October 30, 2012
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01721460

Contacts
Contact: Aeyal Raz, MD, PhD +16082636662 raz@wisc.edu

Locations
United States, Wisconsin
University of Wisconsin - Madison, School of Medicine and Public Health Not yet recruiting
Madison, Wisconsin, United States, 53705
Principal Investigator: Raz Aeyal, MD, PhD         
Sub-Investigator: Banks I Matthew, PhD         
Sub-Investigator: Joel Johnson, MD, PhD         
Sub-Investigator: Robert Pearce, MD, PhD         
Sub-Investigator: Deborah Rusy, MD         
Sub-Investigator: Frank Sasse, MD         
Sub-Investigator: Karl Sillay, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Aeyal Raz, MD, PhD University of Wisconsin, Madison, Department of anesthesiology
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01721460     History of Changes
Other Study ID Numbers: 2012-0400
Study First Received: October 30, 2012
Last Updated: November 1, 2012
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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014