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Intraoperative recording could not be maintained for required period
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD-STN | Experimental | Parkinson's Disease -- STN target |
|
| PD - GPi | Experimental | Parkinson's Disease -- GPi target |
|
| ET - VIM | Experimental | Essential Tremor -- VIM target |
|
| Dystonia - GPi | Experimental | Dystonia -- GPi target |
|
| PD - STN Control | Placebo Comparator | Parkinson's Disease -- STN target |
|
| PD - GPi Control | Placebo Comparator | Parkinson's Disease -- GPi target |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine Hydrochloride Infusion | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Micro-electrode Recordings | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological Exam Findings | Intra-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Neimat, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020329 | Essential Tremor |
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| ET - VIM Control | Placebo Comparator | Essential Tremor -- VIM target |
|
| Dystonia - GPi Control | Placebo Comparator | Dystonia -- GPi target |
|
|
| Normal Saline | Drug | Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery |
|
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |