Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Vanderbilt University |
---|---|
Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00608231 |
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 |
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 |
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
|
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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Joseph Neimat, M.D. | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Joseph Neimat, M.D. ) |
Study ID Numbers: | 070666 |
Study First Received: | January 7, 2008 |
Last Updated: | January 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00608231 |
Health Authority: | United States: Institutional Review Board |
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 |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Nervous System Diseases Physiological Effects of Drugs Central Nervous System Depressants Pharmacologic Actions |
Adrenergic Agonists Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Peripheral Nervous System Agents Central Nervous System Agents |