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PROSPECT: PROspective Study for SymPtomatic Relief of Essential Tremor with Cala Therapy
The purpose of this research study is to evaluate symptomatic hand tremor relief in the treated hand following stimulation with the Cala TWO device. You are being asked to participate in this study because you have been diagnosed with essential tremor by a physician.
This research study is a prospective, single-arm study. The Cala TWO device, which is a stimulator that is worn around the wrist and looks much like a large wrist-watch. The Cala TWO is used to provide symptomatic relief of hand tremors.
In order to participate you must meet the following criteria:
- Are at least 22 years of age.
- Are competent and willing to provide written, informed consent.
You will be excluded from the study if any of the following criteria apply to you:
- Have moderate to severe ethanol dependence as defined by the criteria outlined in the DSM-5 (score of 4 or higher).
- Have an implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator, or implanted metal in the wrist to be stimulated.
This is a partial list of inclusion and exclusion criteria.