Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

This study has been withdrawn prior to enrollment.
(Intraoperative recording could not be maintained for required period)
Sponsor:
Information provided by (Responsible Party):
Joseph Neimat, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00608231
First received: January 7, 2008
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Parkinson's Disease
Essential Tremor
Dystonia
Drug: Dexmedetomidine Hydrochloride Infusion
Drug: Normal Saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Micro-electrode Recordings [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurological Exam Findings [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Placebo control

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00608231

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Joseph Neimat, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Joseph Neimat, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00608231     History of Changes
Other Study ID Numbers: 070666
Study First Received: January 7, 2008
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Parkinson Disease
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on July 31, 2014