Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands

Study Overview
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Brief Summary
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Demonstrate safety and effectiveness of symptomatic action tremor relief in the treated hand following stimulation with the Cala Trio System using the Trio+ bands as compared to the Trio bands in adults with Essential Tremor (ET) and/or Parkinson's Disease (PD) over 2 weeks.

Detailed Description
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20 patients with (13 with ET and 7 with PD) with at least mild postural tremor were enrolled in a prospective, single-center, two-arm, crossover study that took place over the course of four weeks. TAPS devices were shipped to patients to run the study remotely. In the first arm of the study, subjects received TAPS treatment using the original. Cala Trio band for two weeks. Followed by a wash-out period (> 24 hours), subjects entered the second arm and received TAPS using the Trio+ band for an additional two weeks. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.

Official Title
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Prospective Study for Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands

Conditions
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Essential Tremor, Parkinson Disease

Intervention / Treatment
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* Device: Cala Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be ≥22 years of age Competent and willing to provide written, informed consent to participate in the study Willing to comply with study protocol requirements For subjects with Essential Tremor: A diagnosis of essential tremor A tremor severity score of 2 or above in the dominant hand/arm as measured by one of the TETRAS upper limb postural tremor items No significant alcohol intake within 8 hours prior to study visits For subjects with Parkinson's Disease: Dominant hand/arm exhibiting postural tremor ≥ 2 (while in the off state) as assessed by the MDS-UPDRS postural tremor score Stable dose of Parkinson's disease medications, if applicable, for 30 days prior to study entry Exclusion Criteria: Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator Suspected or diagnosed epilepsy or other seizure disorder Any skin condition at the stimulation site that in the investigator's opinion should preclude participation in this study Diagnosed with peripheral neuropathy affecting the tested upper extremity Presence of any other neurodegenerative disease other than essential tremor or Parkinson's Disease Subjects unable to communicate with the investigator and staff Any health condition or concomitant medication that in the investigator's opinion should preclude participation in this study Pregnancy or anticipated pregnancy during the course of the study 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

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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: TAPS delivered by Cala device with Trio band<br>Two 40-minute TAPS sessions daily for 14 days | Device: Cala Device<br>* transcutaneous afferent patterned stimulation (TAPS)<br>|
| Experimental: Experimental: TAPS delivered by Cala device with Trio+ band<br>Two 40-minute TAPS sessions daily for 14 days | Device: Cala Device<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 |
| --- | --- | --- |
| Tremor power changes from pre-stimulation to post-stimulation | Tremor improvement was measured by Tremor Power Improvement Ratio (TPIR) using kinematic data collected by the device. The TPIR was calculated as pre-stimulation power divided by post-stimulation power, which was computed from device-collected accelerometer data | baseline, pre-intervention and immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TETRAS from pre-stimulation to post- stimulation within each visit | For subjects with Essential Tremor only: Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) subset score, relevant to the stimulated upper limb, change from pre-stimulation to post- stimulation within each visit | baseline, pre-intervention and immediately after the intervention | 
| Change in UPDRS Part III from pre-stimulation to post- stimulation within each visit | For subjects with Parkinson's Disease only: Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS) subset score, change from pre- stimulation to post-stimulation within each visit | baseline, pre-intervention and immediately after the intervention | 
| Change in BF-ADL | Change in the Bain & Findley activities of daily living (BF-ADL) score from pre- to post-stimulation at each of the two study visits associated with the Trio and Trio+ bands (four study visits total) | baseline, pre-intervention and immediately after the intervention |