A Phase 2/3 interventional study of Dexmedetomidine Hydrochloride Infusion and Normal Saline in Parkinson's Disease, Essential Tremor and Dystonia, sponsored by Vanderbilt University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-01.
Sponsored by Vanderbilt University · Phase 2/3, Interventional, and Treatment
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:
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
Browse Parkinson Disease studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
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Exclusion Criteria:
Parkinson's Disease -- STN target
Drug: Dexmedetomidine Hydrochloride Infusion
Parkinson's Disease -- GPi target
Drug: Dexmedetomidine Hydrochloride Infusion
Essential Tremor -- VIM target
Drug: Dexmedetomidine Hydrochloride Infusion
Dystonia -- GPi target
Drug: Dexmedetomidine Hydrochloride Infusion
Parkinson's Disease -- STN target
Drug: Normal Saline
Parkinson's Disease -- GPi target
Drug: Normal Saline
Essential Tremor -- VIM target
Drug: Normal Saline
Dystonia -- GPi target
Drug: Normal Saline
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
Also known as: Precedex
Normal Saline intravenous over 10 minutes during deep brain stimulator implantation surgery
Also known as: Placebo control
Micro-electrode Recordings
Time frame: Intra-operative
Neurological Exam Findings
Time frame: Intra-operative
This study is withdrawn, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Vanderbilt University