Cala TAPS (Transcutaneous Afferent Patterned Stimulation) therapy, delivered by Cala Health‘s Cala Trio device, effectively reduces essential tremor (ET) with no loss of effect over time and improves patient quality of life. The real-world evidence provides the largest patient set with the longest usage period, up to two years, of any evaluation of a non-invasive treatment for ET.

The retrospective post-market surveillance study, titled “Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor” and published in Tremor and Other Hyperkinetic Movements (TOHM), evaluated the real-world effectiveness of Cala TAPS therapy based on a total 321 users who had completed at least 90 days of therapy and met the criteria for analysis between August 2019 through June 2021.

Key findings include:

  • TAPS reduced tremor power by 71% (geometric mean), confirming previous findings from the PROSPECT clinical study1. More than half of patients experiencing reduction of tremor power by at least 50%.2
  • No loss of effect was observed with use for longer than a year, with no significant reduction in patients’ tremor power improvement ratio between the first 90 days and beyond a year.
  • Patients completing multiple sessions in a single day experienced no loss of effect when completing multiple sessions in a single day.
  • Patients were instructed by their prescribing physician to use therapy as needed. Patients used therapy an average of 5 to 6 times per week.

These real-world patients were invited to complete a voluntary survey, which showed3:

  • Most patients reported improvement in at least one important activity of daily living: eating (74%), drinking (65%), or writing (64%).
  • Of the patients who were on tremor medication prior to starting Cala TAPS therapy, 24% reduced their tremor medication and 14% discontinued medication use.

This real-world evidence follows a publication in the Journal of Health Economics and Outcomes Research (JHEOR) in August 2022, which found that patients with ET had a significantly higher number of comorbidities (such as hypertension, pain disorders, and diabetes), a higher prevalence of psychiatric disorders (such as depression and anxiety) and higher total healthcare costs than non-ET patients ($17,560 vs $13,237).4

“Historically, patients with ET have had limited treatment options,” said Dr. Salima Brillman, lead author and a movement disorder neurologist at the Parkinson’s Disease and Movement Disorder Center of Silicon Valley. “The evidence, coupled with self-reported quality of life improvement and patient preference for TAPS, reinforce that TAPS is a valuable treatment option for patients with ET. It’s exciting to see advancements for individualized care within the movement disorder space for this patient population.”

“The fact that patients prefer Cala TAPS therapy over standard management options, with some able to reduce or discontinue medications, validates that our solution is transforming the standard of care for patients with essential tremor,” said Renee Ryan, CEO of Cala. “We are proud of this real-world outcome and remain dedicated to improving patients’ quality of life and expanding access and affordability for Cala TAPS therapy.”

The publication was authored by experts from the Parkinson’s Disease and Movement Disorders of Silicon Valley, Edward Fines Jr. VA Hospital, Temple VA Medical Center, Valley Parkinson Clinic, Houston Methodist Neurological Institute, Pacific Neuroscience Institute, Pacific Movement Disorders Center, and Swedish Neuroscience Institute. Data was derived from the healthcare provider-completed prescription form, device logs automatically generated during therapy home use, and a voluntary survey sent to patients after 90 days of therapy use.

1 Isaacson et al. Tremor Other Hyperkinet Mov (N Y). 2020;10:29. doi:10.5334/tohm.59
2 Based on the 216 patients who had tremor measurements for analysis.
3 Based on the 69 patients who had completed the voluntary survey.
4 Dai D, et al. JHEOR. 2022;9(2):37-46. DOI: 10.36469/jheor.2022.37307

[Source(s): Cala Health, Business Wire]