A Pilot Study of the Cala ONE Device for Essential Tremor

Exclusion Criteria

• •Moderate to severe ethanol dependence as defined by the criteria outlined in the DSM-5 (score of 4 or higher)
• •Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
• •Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radiosurgical thalamotomy, and focused ultrasound for the treatment of tremor
• •Suspected or diagnosed epilepsy or other seizure disorder
• •Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
• •Peripheral neuropathy affecting the tested upper extremity
• •Presence of any other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
• •Anyone suspected to have the diagnosis of idiopathic Parkinson's disease (PD). This includes excluding anyone with the presence of parkinsonian features including bradykinesia rigidity, or postural instability. Subjects who exhibit only mild resting tremor but no other symptoms or signs of PD may be included.
• •Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
• •Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor
• •Are participating or have participated in another Cala Health clinical trial
• •Significant alcohol or caffeine consumption within 12 hours of study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee), and significant alcohol is considered more than 14 g (equivalent to 5 oz of wine, 12 oz of beer, or 1.5 oz of distilled spirits).
• •Subjects unable to communicate with the investigator and staff
• •Any health condition that in the investigator's opinion should preclude participation in this study
• •Pregnancy or anticipated pregnancy during the course of the study