Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

June 30, 2014 updated by: Joseph Neimat, Vanderbilt University
To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Deep brain stimulator (DBS) implants are used in the treatment of medically refractory movement disorders such as Parkinson's disease, essential tremor and dystonia. Because of the uniqueness of each individual brain, the surgery to implant a DBS electrode requires detailed anatomic and physiological information for each patient. The anatomic data is obtained before surgery via a Magnetic Resonance Imaging (MRI) scan of the patient's brain. Physiological data is obtained during the operation via micro-electrode recording of the patient's brain and neurological examination of the patient. Therefore, DBS surgery can be uncomfortable to patients, as it can be very time consuming and requires the patient to be awake and attentive.

The specific aims of this project are:

  1. To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery has no significant effect on electrophysiological parameters of DBS micro-electrode recordings.
  2. To test the hypothesis that sedation induced by Dexmedetomidine at levels appropriate for awake, DBS surgery have no significant effects on neurological findings and/or patient cooperation during neurological examination.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient who has agreed to undergo DBS implantation.

Exclusion Criteria:

  • Patients who fail recommendation for DBS surgery discussed in Vanderbilt University Movement Disorder Clinical Conference.
  • Patients not consented for DBS surgery.
  • Patients or legal guardians not able to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-STN
Parkinson's Disease -- STN target
Drug: Dexmedetomidine Hydrochloride Infusion
Dexmedetomidine Hydrochloride Infusion(0.5-1.0 mg/kg)intravenous over 10 minutes with dose adjustment for goal Richmond Agitation and Sedation Scale of -1 During deep brain stimulator implantation surgery
Other Names:
  • Precedex
Experimental: PD - GPi
Parkinson's Disease -- GPi target
Drug: Dexmedetomidine Hydrochloride Infusion
Dexmedetomidine Hydrochloride Infusion(0.5-1.0 mg/kg)intravenous over 10 minutes with dose adjustment for goal Richmond Agitation and Sedation Scale of -1 During deep brain stimulator implantation surgery
Other Names:
  • Precedex
Experimental: ET - VIM
Essential Tremor -- VIM target
Drug: Dexmedetomidine Hydrochloride Infusion
Dexmedetomidine Hydrochloride Infusion(0.5-1.0 mg/kg)intravenous over 10 minutes with dose adjustment for goal Richmond Agitation and Sedation Scale of -1 During deep brain stimulator implantation surgery
Other Names:
  • Precedex
Experimental: Dystonia - GPi
Dystonia -- GPi target
Drug: Dexmedetomidine Hydrochloride Infusion
Dexmedetomidine Hydrochloride Infusion(0.5-1.0 mg/kg)intravenous over 10 minutes with dose adjustment for goal Richmond Agitation and Sedation Scale of -1 During deep brain stimulator implantation surgery
Other Names:
  • Precedex
Placebo Comparator: PD - STN Control
Parkinson's Disease -- STN target
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Other Names:
  • Placebo control
Placebo Comparator: PD - GPi Control
Parkinson's Disease -- GPi target
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Other Names:
  • Placebo control
Placebo Comparator: ET - VIM Control
Essential Tremor -- VIM target
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Other Names:
  • Placebo control
Placebo Comparator: Dystonia - GPi Control
Dystonia -- GPi target
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Other Names:
  • Placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Micro-electrode Recordings
Time Frame: Intra-operative
Intra-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurological Exam Findings
Time Frame: Intra-operative
Intra-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Joseph Neimat, M.D., Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070666

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe