Cala Trio TAPS Device Reduces Severe Tremor in Patients With ET

Kalea Colletta, DO

Data recently presented at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress 2021, September 17-21, found that the Cala Trio, a noninvasive prescription therapy for essential tremor (ET), significantly decreased tremor movement in instances of severe tremor and maintained tremor power in mild instances. 

Investigators, led by Kalea Colletta, DO, department of neurology, Edward Hines Jr. VA Medical Center, evaluated the use of transcutaneous afferent patterned stimulation (TAPS) in a total of 58 VA patients with a median age of 71 years (standard deviation [SD], 10) all of whom used the TAPS device for at least 30 days for 40-minute sessions. On average, patients completed 5.5 sessions each week (SD, 4.3). Patients’ global impressions were collected following a subset of self-rated TAPS sessions (n = 859), with patients reporting 54% sessions as having improved tremor severity.¹ 

According to Colletta, there was a subset of 24 patients who completed 10 sessions worth of motion capture data, of whom 50% experienced a 2-fold or greater improvement in tremor power, with approximately 91% experiencing at least some improvement.^1,2 When using TAPS during times of severe tremor, it was reported that in 76% of sessions were reduced to moderate or mild ranges, depending on the user. When used during mild tremor, investigators found that mild tremor remained consistent in 72% of sessions without worsening, which may indicate that TAPS could be used prophylactically.¹

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When evaluating an individual patient’s tremor severity improvement after using Cala Trio over 20 sessions, it was found that in the instance of severe tremor before therapy, the patient had an 88.1% improvement in tremor power after therapy, when experiencing moderate tremor power pretherapy, the patient had an 83.6% improvement, and when experiencing with mild tremor power pretherapy, the patient had a 79.6% improvement.¹

“These data together suggest that TAPS therapy provides meaningful tremor reduction in cases of more severe tremor in patients who suffer from essential tremor,” Colletta said during her presentation. “This post-market analysis of TAPS therapy in Veterans Affairs essential tremor patients is consistent with findings from prior clinical and post-market studies.”

The Cala Trio TAPS device is worn on the wrist, consisting of a stimulator and detachable band, which contains two working electrodes that deliver TAPS therapy to the median and radial nerves of the arm. Devices are calibrated to individual tremor physiology, with patients performing a postural hold for calibration, as well as before and after a subset of therapy sessions (first 40 sessions, and then after every seventh session). According to Colletta, patients were further instructed to perform TAPS sessions “as needed,” particularly when they needed their hands to be steady, such as while eating or writing. 

“We’re very pleased with the validation from IETF and the research presented at MDS that demonstrates the impactful benefit of our therapy for those suffering from essential tremor,” Kate Rosenbluth, founder, chief science officer, Cala Health, said in a statement.² “It's very gratifying to see the recognition for our vision of freeing people from the burden of chronic disease like ET.”

For more coverage of MDS 2021, click here.

REFERENCES

1. Colletta K, Borucki S, Fujikawa D, et al. Real-world evidence supports use of transcutaneous afferent patterned stimulation for tremor control in Veteran’s Affairs essential tremor patients. Presented at: MDS Congress 2021; September 17-22; Virtual. Poster 70. 
2. Cala Trio is a rising standard of care for the treatment of essential tremor through clinical research and industry guidelines. News release. Cala Health. September 14, 2021. Accessed September 29, 2021. https://www.businesswire.com/news/home/20210914005175/en/Cala-Trio-is-a-Rising-Standard-of-Care-for-the-Treatment-of-Essential-Tremor-through-Clinical-Research-and-Industry-Guidelines