The purpose of the proposed study is to demonstrate that the functional outcomes of DBS
surgery utilizing the "asleep" technique are not inferior to those reported for traditional
"awake" DBS technique.
Procedure: Deep Brain Stimulation surgery
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Locations near you
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Full eligibility criteria for NCT02401308
Ages eligible for Study
18 Years to 85 Years
Genders eligible for Study
Accepts Healthy Volunteers
Parkinson's disease per Queens Square criteria
Appropriate DBS candidate for multi-disciplinary team consensus
Age 18 - 85 years of age
Motor skills allowing for capability to complete evaluations
Medically cleared for undergoing anesthesia and DBS surgery
Dementia per DSM-V criteria
Medical or other condition precluding MRI
History of supraspinal CNS disease other than PD
Alcohol use of more than 4 drinks per day
History of suicide attempt
Currently uncontrolled clinically significant depression (BDI>20)
History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
All locations for NCT02401308
United States (1)
Barrow Neurological Institute / St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States, 85013
View full eligibility
Tris trial is registered with FDA with number: NCT02401308. The sponsor of the trial is St. Joseph's Hospital and Medical Center, Phoenix and it is looking for 1 volunteers for the current phase.
Official trial title: Randomized Controlled Clinical Trial Comparing Functional Outcomes of Awake vs. Asleep Deep Brain Stimulation (DBS) for Parkinson's Disease
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