Essential Tremor Healthcare Professional Information

Cala TAPS therapy, delivered by Cala Trio, is the only FDA-cleared, clinically proven, non-invasive treatment for ET Patients

How TAPS works

Transcutaneous Afferent Patterned Simulation (TAPS) therapy delivers meaningful tremor improvement without drugs or surgery.

The Cala Trio device is an FDA-cleared Class II Medical Device for the external upper limb tremor stimulator and is safe, effective, and individually calibrated to each patient’s unique brain signal pattern.^1,2,3Cala Trio therapy is the first and only wrist-worn medical device designed to treat the source of the hand tremor by gently stimulating the wrist nerves with electricity (neuromodulation), which targets the root cause of the hand tremor.

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

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Clinical Evidence

What is the PROSPECT study?

PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy. Cala sponsored the largest non-invasive therapeutic clinical research study ever conducted at 26 clinical sites, 231 patients were enrolled in a 3-month study.

68%

68% of patients who self-rated as having “Severe or Moderate” difficulty in their activities of daily living self-rated as “Mild” or better at the end of the study. (Reported by patients using Bain-Finley Activities of Daily Living (BF-ADL).¹

62%

62% of patients improved from “Severe” or “Moderate” tremor at the beginning of the study to “Mild” or “Slight” tremor. (As measured by physicians using TETRAS.)¹

64%

64% of patients reported having persistent relief for an average of 94 minutes (standard deviation = 138; median = 60).¹

Real World Clinical Evidence

A retrospective post-market surveillance study evaluated the real-world effectiveness of Cala Trio therapy based on a total 321 users. This data further confirms efficacy findings from PROSPECT and provides insight into long-term usage of peripheral neuromodulation.⁴

Isaacson SH, et al. Tremor and Other Hyperkinetic Movements. 2020;10:29. doi:10.5334/tohm.59. As measured by Cala device following three months of repeated home use in 205 patients with essential tremor who completed the study. Many participants were also taking medication for their tremor and it was difficult to assess the effect of the device compared to medication.
Safety information. The most common reported side effects include mild to moderate skin irritation, including electrical stimulation burns, redness, and/or itching where the device touched the skin. For comprehensive safety information, visit CalaTrio.com/Safety.
The Cala Trio device is cleared by the FDA as an external upper limb tremor stimulator, Class II (initially under de novo DEN170028 with subsequent 510(k) clearances K182706 and K203288).
Brillman S, Colletta K, Borucki S, Lin PT, Waln O, Petrossian M, et al.. Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor. Tremor and Other Hyperkinetic Movements. 2022;12(1):27