Clinical evidence center
Dig deeper into our clinical studies and learn more about Cala TAPS therapy.
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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.
Featured publications
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.
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.
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.
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.
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.
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.
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.