Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

Study Overview
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Brief Summary
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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
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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: 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. 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.

Official Title
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Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation

Conditions
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Parkinson's Disease, Essential Tremor, Dystonia

Intervention / Treatment
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* Drug: Dexmedetomidine Hydrochloride Infusion
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD-STN<br>Parkinson's Disease -- STN target | Drug: Dexmedetomidine Hydrochloride Infusion<br>* 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<br>* Other names: Precedex;|
| Experimental: PD - GPi<br>Parkinson's Disease -- GPi target | Drug: Dexmedetomidine Hydrochloride Infusion<br>* 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<br>* Other names: Precedex;|
| Experimental: ET - VIM<br>Essential Tremor -- VIM target | Drug: Dexmedetomidine Hydrochloride Infusion<br>* 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<br>* Other names: Precedex;|
| Experimental: Dystonia - GPi<br>Dystonia -- GPi target | Drug: Dexmedetomidine Hydrochloride Infusion<br>* 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<br>* Other names: Precedex;|
| Placebo Comparator: PD - STN Control<br>Parkinson's Disease -- STN target | Drug: Normal Saline<br>* Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery<br>* Other names: Placebo control;|
| Placebo Comparator: PD - GPi Control<br>Parkinson's Disease -- GPi target | Drug: Normal Saline<br>* Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery<br>* Other names: Placebo control;|
| Placebo Comparator: ET - VIM Control<br>Essential Tremor -- VIM target | Drug: Normal Saline<br>* Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery<br>* Other names: Placebo control;|
| Placebo Comparator: Dystonia - GPi Control<br>Dystonia -- GPi target | Drug: Normal Saline<br>* Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery<br>* Other names: Placebo control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Micro-electrode Recordings |  | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological Exam Findings |  | Intra-operative |