Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

• ClinicalTrials.gov Identifier: NCT00608231
• Recruitment Status: Withdrawn
• First Posted: February 6, 2008
• Last Update Posted: July 1, 2014
• Sponsor: Vanderbilt University
• Information provided by (Responsible Party): Joseph Neimat, Vanderbilt University

Tracking Information

• First Submitted Date: January 7, 2008
• First Posted Date: February 6, 2008
• Last Update Posted Date: July 1, 2014
• Study Start Date: January 2008
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 25, 2008): Micro-electrode Recordings [ Time Frame: Intra-operative ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00608231 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: January 25, 2008): Neurological Exam Findings [ Time Frame: Intra-operative ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Parkinson's Disease
• Essential Tremor
• Dystonia

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 20, 2013): 0
• Original Estimated Enrollment (submitted: January 25, 2008): 90
• Actual Study Completion Date: January 2012
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00608231
• Other Study ID Numbers: 070666
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Joseph Neimat, Vanderbilt University
• Study Sponsor: Vanderbilt University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Vanderbilt University
• Verification Date: June 2014