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Effects of Dexmedetomidine on Activity in the Subthalamic Nucleus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01721460
First Posted: November 5, 2012
Last Update Posted: November 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
The purpose of this research study is to find out whether dexmedetomidine changes brain cell activity in the subthalamic nucleus (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: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.


Enrollment: 6
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: Dexmedetomidine during MER
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.
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

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721460


Locations
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
Investigators
Principal Investigator: Aeyal Raz, MD, PhD University of Wisconsin, Madison, Department of anesthesiology
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01721460     History of Changes
Other Study ID Numbers: 2012-0400
First Submitted: October 30, 2012
First Posted: November 5, 2012
Results First Submitted: June 1, 2017
Results First Posted: November 2, 2017
Last Update Posted: November 2, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
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