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 II
Phase III

Genetics Home Reference related topics:   Parkinson disease   essential tremor  

MedlinePlus related topics:   Dystonia   Parkinson's Disease   Surgery   Tremor  

ChemIDplus related topics:   Sodium chloride   Dexmedetomidine   Dexmedetomidine hydrochloride  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

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 ]

Estimated Enrollment:   90
Study Start Date:   January 2008
Estimated Study Completion Date:   January 2010
Estimated Primary Completion Date:   January 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
PD-STN: Experimental
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
PD - GPi: Experimental
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
ET - VIM: Experimental
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
Dystonia - GPi: Experimental
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
PD - STN Control: Placebo Comparator
Parkinson's Disease -- STN target
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
PD - GPi Control: Placebo Comparator
Parkinson's Disease -- GPi target
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
ET - VIM Control: Placebo Comparator
Essential Tremor -- VIM target
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Dystonia - GPi Control: Placebo Comparator
Dystonia -- GPi target
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608231

Contacts
Contact: Joseph Neimat, M.D.     615-322-7417     joseph.neimat@Vanderbilt.Edu    
Contact: Melba T. Isom     615-343-9822     melba.isom@vanderbilt.edu    

Locations
United States, Tennessee
Vanderbilt University Medical Center     Recruiting
      Nashville, Tennessee, United States, 37232

Sponsors and Collaborators
Vanderbilt University

Investigators
Principal Investigator:     Joseph Neimat, M.D.     Vanderbilt University    
Contact: Joseph Neimat, M.D.     615-322-7417     joseph.neimat@Vanderbilt.Edu    
Contact: Melba T. Isom     615-343-9822     melba.isom@vanderbilt.edu    
United States, Tennessee
Vanderbilt University Medical Center     Recruiting
      Nashville, Tennessee, United States, 37232
Vanderbilt University
Principal Investigator:     Joseph Neimat, M.D.     Vanderbilt University    
  More Information

Responsible Party:   Vanderbilt University ( Joseph Neimat, M.D. )
Study ID Numbers:   070666
First Received:   January 7, 2008
Last Updated:   January 25, 2008
ClinicalTrials.gov Identifier:   NCT00608231
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Dystonic Disorders
Essential Tremor
Ganglion Cysts
Basal Ganglia Diseases
Dystonia
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Tremor
Dyskinesias
Signs and Symptoms
Movement Disorders
Parkinson Disease
Benign essential tremor syndrome
Neurologic Manifestations
Dexmedetomidine
Parkinsonian Disorders

Additional relevant MeSH terms:
Essential Tremor
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Adrenergic Agonists
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

Source: National Library of Medicine (NLM) July 07, 2008

  


 
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