RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor

Study Overview
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Brief Summary
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The study objective is to evaluate hand tremor relief in the treated hand following stimulation with the Cala Trio Device in adults with essential tremor, and healthcare resource utilization and total healthcare costs over a 12-month period.

Detailed Description
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This is a prospective, randomized, dual arm, pragmatic trial in a real-world setting to evaluate the effectiveness and health economics outcomes of the Cala Trio device in reducing hand tremor and improving quality of life as measured by the Bain and Findley Activities of Daily Living (ADL) score relevant to the stimulated upper limb. Healthcare resources utilization and total all-cause healthcare will also be evaluated. The study will recruit approximately 300 patients: 150 in the intervention arm (Cala Trio device)and 150 patients in the standard of care (SOC) arm. Subjects will be randomized to either the intervention arm or the standard of care arm (1:1).Subjects in the SOC arm will be asked to measure their tremor severity by doing daily postural holds with the Cala Trio device without actual stimulation. Subjects in the intervention arm will wear the device at home for a period of 12 months, during which they will deliver 40 min stimulation sessions, which can be started and stopped on demand. After the first month, the subjects who were randomized to the SOC arm will cross over to the intervention arm.

Official Title
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Real World Evidence Study Utilizing the Cala Trio Device in Patients With Essential Tremor

Conditions
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Essential Tremor

Intervention / Treatment
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* Device: Cala Trio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥22years Aetna commercial fully insured OR Medicare Advantage population (inclusion of Medicare is contingent upon additional internal approvals) Two ICD claims for ET, at least seven days apart, in the last three years OR one ICD claim for ET followed by at least one dispensed pharmaceutical treatment for ET Contraindication to standard pharmacological therapy (Asthma, COPD, 1stor 2nddegree heart block) OR indicator of poor pharmacological acceptability as evidenced by drug switching behaviors OR indicator of drug resistance as evidenced by the use of third-line drug therapies including Clozapine, Mirtazapine, Gabapentin, Topiramate, Clonazepam or Alprazolam Willing and able to provide informed consent to participate in the study Willing and able to follow study protocol requirements Patients with PCP or neurologist provider encounter in past 18months Exclusion Criteria: ICD-10 evidence of a pacemaker or defibrillator or a procedure code indicating pacemaker implantation, electrode renewal or calibration ICD-10 evidence of a deep brain stimulator or a procedure code indicating DBS implantation CPT/HCPCS evidence of thalamotomy, gamma-knife radio surgical thalamotomy NDC and CPT evidence of botulinum toxin the last 6 months as therapeutic injection in the upper limb Pregnant during the enrollment period Evidence of Parkinson's Disease Evidence of epilepsy Formal diagnosis of hypothyroidism and treatment Formal diagnosis of hyperthyroidism without evidence of treatment Formal diagnosis of dementia Evidence of Treatment with thyroid hormone supplements (2 Rx claims 28 or more days apart) or evidence of hyperthyroidism (2+ claims, 28 days or more apart)

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care Arm<br>Baseline tremor power without stimulation (SOC arm) over the first month of the study. Subjects in the SOC arm will be asked to measure their tremor severity by doing daily postural holds with the Cala Trio device without actual stimulation. | |
| Experimental: Intervention with the Cala Trio device (CTD) arm<br>Tremor power after stimulation with Cala Trio. Subjects in the intervention arm will wear the device at home for a period of 12 months, during which they will deliver 40 min stimulation sessions, which can be started and stopped on demand. | Device: Cala Trio<br>* transcutaneous afferent patterned stimulation (TAPS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tremor power | Difference in tremor power after stimulation with Cala Trio (treated arm) and baseline tremor power without stimulation (SOC arm) over the first month of the study. Prior to and immediately after each of the first 40 stimulation sessions and every 7th session thereafter, the Cala Trio will direct the patient to perform postural hold tremor tasks to measure tremor power pre and post stimulation. The SOC arm will perform a tremor measurement only, without any stimulation sessions, for 1 month. | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bain & Findley Activities of Daily Living (ADL) scale subset score | Bain & Findley ADL subset score relevant to the stimulated upper limb. The subset score is the sum of 8 rated tasks. Each task is rated 1 to 4, where a higher score indicates more severe tremor. Minimum subset score = 8; Maximum subset score = 32. | Month 1, 3, 6, 9 and 12 |