Clinical trial: A Pilot Study of the Cala ONE Device for Essential Tremor (NCT03152136)

Eligibility criteria:
Inclusion Criteria:

          -  Must be ≥22 and ≤80 years of age

          -  Competent and willing to provide written, informed consent to participate in the study

          -  A diagnosis of essential tremor as confirmed from clinical history and examination by
             a movement disorder neurologist

          -  Postural, action or intention tremor severity score of 2 or above in the dominant
             hand/arm as measured by the CRST rating scale

          -  Significant disability due to essential tremor (Bain & Findley score of 3 or above in
             any one of the hand items)

          -  Currently or previously prescribed either propranolol or primidone for the treatment
             of essential tremor

          -  Stable dose of tremor medications for 30 days prior to study entry

          -  Stable dose of antidepressant medications for 90 days prior to study entry

          -  Willing to comply with study protocol requirements including: remaining on a stable
             dosage of tremor and antidepressant medications, if applicable, during the duration of
             the study; no significant alcohol or caffeine consumption within 12 hours of study
             visits; and no significant alcohol or caffeine consumption within 4 hours of
             twice-daily at home assessments during the controlled phase of the study

        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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? Entailment