Wrist device effectively reduces essential tremor
Click Here to Manage Email Alerts
Cala Trio, a wrist-worn device that stimulates wrist nerves to disrupt tremulous activity in the brain, safely and effectively reduced essential tremor in patients, data from a prospective study showed.
“Living with essential tremor can be physically and psychologically draining,” Rajesh Pahwa, MD, director of the Parkinson Foundation Center of Excellence at the University of Kansas Medical Center, told Healio Primary Care. “Other current treatment options include medications that have up to 70% efficacy, and in some patients, can have significant side effects.”
In the new study — called PROSPECT — 263 patients across 26 sites were instructed to use Cala Trio (Cala Health) twice daily for 3 months. The device was used at home for about 40 minutes at a time. The co-primary endpoints were improvements in patients’ dominant hands using the clinician-rated Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) and the patient-rated Bain & Findley Activities of Daily Living (BF-ADL) scale.
“The study was run without a blinded sham arm due to the challenge of mimicking the sensation of stimulation or otherwise maintaining blind with an at-home device over 3 months of repeated use,” Stuart H. Isaacson, MD, neurologist at Boca Raton Regional Hospital in Florida, and colleagues wrote in Tremor and Other Hyperkinetic Movements.
According to the researchers, both co-primary endpoints were met. At 3 months, 62% of patients with “severe” or ”moderate” baseline scores improved to “mild” or “slight” based on the TETRAS, and 68% experienced similar improvements based on the BF-ADL (P for both < .0001).
Also at 3 months, clinicians reported improvement in 68% of patients based on the Clinical Global Impression of Improvement (CGI-I) scale. Using the Patient Global Impression of Improvement (PGI-I) scale, 60% of patients reported improvement, and Quality of Life in Essential Tremor (QUEST) scores improved as well (P = .0019). According to the researchers, adverse events occurred in 18% of patients and included pain, skin irritation and wrist discomfort. No device-related serious adverse events were reported.
“Cala Trio is the only noninvasive, wrist-worn therapy for essential tremor, with minimal side effects,” Pahwa said.
The Cala Trio was cleared by the FDA in 2018. A Cala Health spokesperson told Healio Primary Care that researchers are now investigating its potential for other neurological diseases, as well as psychiatric and cardiovascular conditions.
Perspective
Back to Top
David Shprecher, DO
Essential tremor is one of the most common movement disorders. Some studies suggest that as many as 5% of individuals aged 65 years and older have essential tremor. This prevalence rises above 10% among those aged 85 years and older.
Cala Trio had been shown to be effective in two small, single-session, placebo-controlled trials, leading to FDA clearance of the device. The primary goal of this study was to determine if Cala Trio improved tremor severity over a 3-month period. Based on clinician and patient ratings, most patients with severe or moderate tremor severity improved to mild or slight.
There are several essential tremor treatment options currently available. The first — pills and capsules — have been around a long time, but they are not always effective or well-tolerated. A second option, adaptive devices, include Liftware, which has a fork, spoon or knife attachment that will move against the tremor. However, patients often must pay out-of-pocket for therapies like this. A third option, surgery, involves deep brain stimulation or doing a radiosurgery (ultrasound or gamma knife) ablation of the ventral intermediate nucleus of the thalamus. This approach is more invasive and is associated with complication risks.
Cala Trio is noninvasive and does not have the side effects of oral medications, nor the complication risks of invasive procedures. What remains to be seen is whether it will be made broadly available and affordable. My experience with similar other devices for movement disorders is that it can take a long time after the FDA gives approval before insurance starts to cover them and/or the cost of treatment becomes affordable to most patients.
Collapse
Read more about
Click Here to Manage Email Alerts