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Mechanism of Action: Essential Tremor Relief with Peripheral Non-invasive Neuromodulation

This whitepaper describes the mechanism of action and supporting evidence behind TAPS Therapy for ET.

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Featured publications

Dai et al. Comparative Effectiveness of Transcutaneous Afferent Patterned Stimulation Therapy for Essential Tremor: A Randomized Pragmatic Clinical Trial. Tremor and Other Hyperkinetic Movements. 2023; 13(1): 38, pp. 1–16.

A randomized pragmatic trial by CVS Health found that adding Cala TAPS therapy to standard of care (SOC) improved outcomes over SOC alone. The study recruited patients from the database of a large health insurer (AETNA) and represents the largest prospective device study run in essential tremor to-date (N = 310). The study found significant improvements in tremor power (measured by motion sensors) and Bain & Findley Activities of Daily Living (BF-ADL) upper limb scores over one month of TAPS compared to SOC alone, demonstrating that TAPS is a safe and effective treatment option for patients with ET.

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Lu et al. Transcutaneous Afferent Patterned Stimulation for Essential Tremor: Real-World Evidence with Long Term Follow-Up. Tremor and Other Hyperkinetic Movements. 2023; 13(1): 29, pp. 1–13.

A large real-world evidence (RWE) analysis found that patients using Cala TAPS therapy achieved consistent relief over multiple years of use.  This study examined the real-world application of Cala TAPS therapy by analyzing usage (N = 1223) and effectiveness data (N = 808) collected from device logs and voluntary patient surveys. Consistent with previous findings, the study found Cala TAPS Therapy effectively reduces tremor with an average reduction in tremor power (measured by motion sensors) of 64%. Further, the study reported consistent usage with no significant habituation over long term use (up to 3.4 years).

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Isaacson et al. Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies. Expert Review of Medical Devices, 20(12), 1211–1218.

A secondary analysis of previously published studies assessed TAPS response in patients with high unmet need and patients who observed benefit from TAPS therapy during their first month of use (early responders).  The study found significant improvement over sham in the high unmet need subgroup (severe tremor, non-responsive to medication, age ≥65 years) of a randomized controlled study (N = 47, P < 0.03) and significant improvements over multiple months of use in the high unmet need (N = 138, P < 0.001) and early responder cohort (N = 51, P < 0.001).

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Isaacson et al. Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor

Tremor and Other Hyperkinetic Movements. 2020; 10(1): 29, pp. 1–16

PROSPECT (Prospective Study for Symptomatic Relief of ET with Cala Therapy) was a prospective, multicenter, single-arm, open-label clinical trial to evaluate the efficacy and safety of TAPS therapy in patients with ET across 26 sites in the US. In summary, non-invasive neuromodulation with TAPS therapy used repeatedly at home over 3 months resulted in safe and effective hand tremor reduction in many patients with ET.

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Brillman et al. Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor

Tremor and Other Hyperkinetic Movements. 2022; 12(1): 27, pp. 1–11.

This retrospective post-market surveillance analysis evaluated the real-world effectiveness of TAPS Therapy from patients using it on-demand for at least 90 days. The analysis provides real-world evidence that is consistent with prior clinical trials, and confirms that TAPS provides safe and effective tremor control over a prolonged duration of up to 18 months for many patients with ET.

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Yu et al. Transcutaneous Afferent Patterned Stimulation Therapy Reduces Hand Tremor for One Hour in Essential Tremor Patients

Front. Neurosci., 12 November 2020

A single-arm, open-label study that characterizes the time-profile of therapeutic benefit from TAPS Therapy for up to 60 minutes following a stimulation session. It provides evidence to support that TAPS Therapy has a safe and durable effect on ET for at least 60 minutes following stimulation. It also suggests that sensor data recorded before, during, and immediately following stimulation can be used to understand therapeutic response in an at-home setting.

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Lin et al. Noninvasive Neuromodulation in Essential Tremor Demonstrates Relief in a Sham-controlled Pilot Trial

Movement Disorders, Vol. 33, No. 7, 2018 (1182-1183)

This study evaluated the efficacy of median and radial nerve stimulation as a noninvasive, non-pharmacological treatment to aid in the symptomatic relief of hand tremor in individuals with ET. This randomized, sham-controlled pilot study suggests that noninvasive neuro-peripheral therapy may offer clinically meaningful symptomatic relief from hand tremor in ET, with a favorable side effect profile compared to other available therapies.

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Pahwa et al. An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor

Neuromodulation 2019; 22: 537–545

This prospective, multicenter, randomized, sham-controlled trial evaluated the safety and efficacy of Cala TAPS Therapy, in a wrist-worn peripheral nerve stimulation device, for the treatment of hand tremor in adults with ET. Treatment resulted in significant reduction in tremor and an improvement in function in patients with hand tremor symptoms. The therapy was safe and well-tolerated.

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Barath et al. Brain Metabolic Changes with Longitudinal Transcutaneous Afferent Patterned Stimulation in Essential Tremor Subjects

Tremor and Other Hyperkinetic Movements. 2020; 10(1): 52, pp. 1–10.

A Positron Emission Tomography (PET) study that investigated the baseline metabolic changes from 3 months of twice-daily TAPS Therapy observed in Isaacson et al. This study demonstrated metabolic changes in the tremor network and showed encouraging correlation (r = 0.7) between PET and TETRAS baseline, suggesting the baseline improvement observed in PROSPECT comes from changes in neural firing patterns that are now being explored for chronic preventative dosing.

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Dai et al. Multiple Comorbidities, Psychiatric Disorders, Healthcare Resource Utilization and Costs Among Adults with Essential Tremor: A Retrospective Observational Study in a Large US Commercially Insured and Medicare Advantage Population

JHEOR. 2022;9(2):37-46.

Essential tremor (ET), the most common movement disorder, often impairs patients’ ability to perform activities of daily living, mental health, and quality of life. This retrospective observational study was conducted using a large US administrative claims database. The data demonstrate increased comorbidity, mental health, and healthcare cost burdens among ET patients compared with matched non-ET patients. These findings underscore the need for innovative care for this complex population.

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