Dystonia, Essential Tremor, Parkinson's Disease
Conditions
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.
Interventions
DRUGDexmedetomidine 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
DRUGNormal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Micro-electrode Recordings | Intra-operative |
Secondary
| Measure | Time frame |
|---|---|
| Neurological Exam Findings | Intra-operative |
Countries
United States
Outcome results
None listed