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Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

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ClinicalTrials.gov Identifier: NCT00608231
Recruitment Status : Withdrawn (Intraoperative recording could not be maintained for required period)
First Posted : February 6, 2008
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Joseph Neimat, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE January 7, 2008
First Posted Date  ICMJE February 6, 2008
Last Update Posted Date July 1, 2014
Study Start Date  ICMJE January 2008
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
Micro-electrode Recordings [ Time Frame: Intra-operative ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00608231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
Neurological Exam Findings [ Time Frame: Intra-operative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
Official Title  ICMJE Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
Brief Summary 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson's Disease
  • Essential Tremor
  • Dystonia
Intervention  ICMJE
  • 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 Name: Precedex
  • Drug: Normal Saline
    Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
    Other Name: Placebo control
Study Arms  ICMJE
  • Experimental: PD-STN
    Parkinson's Disease -- STN target
    Intervention: Drug: Dexmedetomidine Hydrochloride Infusion
  • Experimental: PD - GPi
    Parkinson's Disease -- GPi target
    Intervention: Drug: Dexmedetomidine Hydrochloride Infusion
  • Experimental: ET - VIM
    Essential Tremor -- VIM target
    Intervention: Drug: Dexmedetomidine Hydrochloride Infusion
  • Experimental: Dystonia - GPi
    Dystonia -- GPi target
    Intervention: Drug: Dexmedetomidine Hydrochloride Infusion
  • Placebo Comparator: PD - STN Control
    Parkinson's Disease -- STN target
    Intervention: Drug: Normal Saline
  • Placebo Comparator: PD - GPi Control
    Parkinson's Disease -- GPi target
    Intervention: Drug: Normal Saline
  • Placebo Comparator: ET - VIM Control
    Essential Tremor -- VIM target
    Intervention: Drug: Normal Saline
  • Placebo Comparator: Dystonia - GPi Control
    Dystonia -- GPi target
    Intervention: Drug: Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 20, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2008)
90
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00608231
Other Study ID Numbers  ICMJE 070666
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph Neimat, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Neimat, M.D. Vanderbilt University Medical Center
PRS Account Vanderbilt University
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP