Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation
This study is ongoing, but not recruiting participants.
Sponsor:
Vanderbilt University
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00608231
First received: January 7, 2008
Last updated: July 11, 2011
Last verified: July 2011
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Dexmedetomidine Effects on Microelectrode Recording in Deep Brain Stimulation |
Resource links provided by NLM:
Genetics Home Reference related topics:
dopa-responsive dystonia
early-onset primary dystonia
essential tremor
Parkinson disease
Perry syndrome
U.S. FDA Resources
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 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PD-STN
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
Other Name: Precedex
|
|
Experimental: PD - GPi
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
Other Name: Precedex
|
|
Experimental: ET - VIM
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
Other Name: Precedex
|
|
Experimental: Dystonia - GPi
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
Other Name: Precedex
|
|
Placebo Comparator: PD - STN Control
Parkinson's Disease -- STN target
|
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Other Name: Placebo control
|
|
Placebo Comparator: PD - GPi Control
Parkinson's Disease -- GPi target
|
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Other Name: Placebo control
|
|
Placebo Comparator: ET - VIM Control
Essential Tremor -- VIM target
|
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Other Name: Placebo control
|
|
Placebo Comparator: Dystonia - GPi Control
Dystonia -- GPi target
|
Drug: Normal Saline
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Other Name: Placebo control
|
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:
- 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.
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
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
Sponsors and Collaborators
Vanderbilt University
Investigators
| Principal Investigator: | Joseph Neimat, M.D. | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | Joseph Neimat, M.D., Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00608231 History of Changes |
| Other Study ID Numbers: | 070666 |
| Study First Received: | January 7, 2008 |
| Last Updated: | July 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Dystonia Dystonic Disorders Parkinson Disease Tremor Essential Tremor Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases |
Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |
ClinicalTrials.gov processed this record on May 23, 2013