A Pilot Study of the Cala ONE Device for Essential Tremor

Study Overview
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Brief Summary
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Prospective, multi-center, randomized, controlled study designed to evaluate safety and repeatable effectiveness. Subjects will be randomized 2:1:1 to transcutaneous afferent patterned stimulation (TAPS), sham, or 'no intervention', respectively. Subjects randomized to the TAPS and sham arms will be blinded to their randomization assignments for the first two weeks of participation (controlled phase). After the first two weeks, all subjects will be crossed over to TAPS (open-label phase) for 2 weeks. During study participation, all subjects are to remain on a stable dosage of medications prescribed for the treatment of essential tremor, if applicable.

Official Title
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A Pilot Study to Evaluate the Safety and Initial Effectiveness of the Cala ONE Device to Repeatably Aid in the Symptomatic Relief of 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: 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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 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
Interventional Model Description: The first two weeks are a 3-arm parallel design (treatment, sham, and 'no intervention'). The second two weeks are open-label (all subjects cross-over to treatment arm).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAPS<br>Subjects will receive a Cala ONE device that delivers TAPS, transcutaneous afferent patterned stimulation. | Device: Cala ONE device<br>* The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves.<br>|
| Sham Comparator: Sham<br>Subjects will receive a Cala ONE device that delivers sham stimulation. | Device: Cala ONE device<br>* The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves.<br>|
| No Intervention: No Intervention<br>Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Tremor Power | For TAPS and sham arms, subjects will be prompted to perform a lateral postural hold prior to entering their PGI-S score before and after each stimulation session. During this hold, the device will record motion data to objectively assess if there are any changes in tremor level. | Mean tremor power pre stimulation over two weeks of device usage as compared to mean tremor power post stimulation over two weeks of device usage. |