Clinical trial: Cala ONE Device for Essential Tremor (NCT02629614)

Eligibility criteria:
Inclusion Criteria:

          1. 22 years or older

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

          3. Signed informed consent

          4. At least one hand exhibiting kinetic tremor ≥ 2 as assessed by the TETRAS Archimedes
             spiral task completed during the baseline evaluation, as assessed by the Investigator
             in-person.

          5. Score of 3 or above in any one of the items of the Bain & Findley ADL Scale

        Exclusion Criteria:

          1. Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain
             stimulator

          2. Previous thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife
             Radiosurgical Thalamotomy, and focused ultrasound, for the treatment of tremor

          3. Suspected or diagnosed epilepsy or other seizure disorder

          4. Pregnant

          5. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous
             lesions of skin at stimulation site

          6. Peripheral neuropathy affecting the tested upper extremity

          7. Alcoholism (score of 4 or higher on DSM-5)

          8. Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced
             physiological tremor, dystonia

          9. Other neurodegenerative disease like Parkinson-plus syndromes suspected on
             neurological examination. These include: multisystem atrophy, progressive supranuclear
             palsy, dementia with Lewy bodies, and cortical basal ganglionic degeneration

         10. Changes in medication for tremor within 1 month prior to study enrollment

         11. Change in antidepressant medication within 3 months prior to study enrollment

         12. Botulinum Toxin injection for hand tremor within 6 months prior to study enrollment

         13. Current participation in any other interventional research study

         14. Previous participation in any other Cala Health interventional research study

         15. Alcohol or caffeine consumption within 12 hours of study enrollment

        Subjects already taking medications for their essential tremor will remain on their
        medications during the study with no changes in medication type or dosage levels.
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.


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? 1