Cala ONE Device for Essential Tremor

Study Overview
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Brief Summary
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This study evaluates the safety and effectiveness of the Cala ONE device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. This study is a prospective, randomized, double-blinded, sham-controlled study.

Official Title
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Multicenter Study of Safety and Effectiveness of Cala ONE Device for Essential Tremor

Conditions
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Essential Tremor

Intervention / Treatment
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* Device: Cala ONE Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 22 years or older A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist Signed informed consent 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. Score of 3 or above in any one of the items of the Bain & Findley ADL Scale Exclusion Criteria: 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 Pregnant Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site Peripheral neuropathy affecting the tested upper extremity Alcoholism (score of 4 or higher on DSM-5) Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor, dystonia 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 Changes in medication for tremor within 1 month prior to study enrollment Change in antidepressant medication within 3 months prior to study enrollment Botulinum Toxin injection for hand tremor within 6 months prior to study enrollment Current participation in any other interventional research study Previous participation in any other Cala Health interventional research study 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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAPS Stimulation<br>Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. | Device: Cala ONE Device<br>* The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.<br>|
| Sham Comparator: Sham Stimulation<br>0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device. | Device: Cala ONE Device<br>* The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TETRAS Spiral Rating After Stimulation | The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Immediately before and after 40 minute stimulation session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TETRAS Spiral Rating During Stimulation | An additional analysis variable is the change in tremor severity during the stimulation session (30 minutes into stimulation session) compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors. | Immediately before and 30 minutes into stimulation session | 
| Self-report Improvement | The percentage of subjects in the treatment group indicating improvement on the CGI-I Scale will be compared to the sham group. The Clinical Global Impression - Improvement (GGI-I) scale evaluates a clinician's rating of tremor improvement noted in the subject, as a result of the treatment. The scale ranges from 1 (very much improved) to 7 (very much worse). | Immediately before and after 40 minute stimulation session |