Cala announced today that real-world evidence validates its transcutaneous afferent patterned stimulation (TAPS) therapy for treating tremor.
San Mateo, California-based Cala delivers TAPS therapy with its Cala Trio device. It designed the treatment to reduce tremor in those living with essential tremor (ET).
Data from the study validates TAPS in effectively reducing tremor, Cala said. The therapy did so with no loss of effect over time while improving patient quality of life, according to a news release.
Cala shared the data from a retrospective post-market surveillance study. “Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor” evaluated the real-world effectiveness of Cala TAPS therapy. It evaluated 321 users who completed at least 90 days of therapy and met the criteria for analysis. The study took place between August 2019 through June 2021.
In the study, TAPS reduced tremor power by 71%, confirming previous findings from the PROSPECT clinical study. More than half of patients experienced a reduction of tremor power by at least 50%. A real-world evaluation of 44 users of the wearable Cala Trio from 2020 found 93% of users reduced tremor power by at least half.
Cala observed no loss of effect with use for longer than one year. Additionally, it saw no significant reduction in tremor power improvement between the first 90 days and beyond a year. Patients completing multiple sessions in one day experienced no loss of effect, too. They used therapy an average of five to six times per week, having been instructed by physicians to use therapy as needed.
Most patients reported improvements in at least one important activity of daily living. That includes eating (74% reported improvement), drinking (65%) or writing (64%). Of patients on tremor medication before Cala TAPS therapy, 24% reduced their medication and 14% discontinued medication use.
Cala “proud” of real-world outcomes
“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.”
Data came from a healthcare provider-completed prescription form. It also came out of device logs automatically generated during therapy home use and a voluntary survey sent to patients after 90 days of therapy use.
“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.”