Treating Patients With Essential Tremor with Wristwatch-Style Neuromodulation

Monday, April 30, 2018

Using a wrist-worn neuromodulation device (Cala Health Inc, Burlingame, CA) that stimulates the radial and median nerves, people with essential tremor may find some relief from a new, noninvasive type of nerve stimulation. Results from 2 randomized controlled studies were presented at the American Academy of Neurology meeting in Los Angeles.

Tremor severity was measured using sensors on the device before and after each therapy session. People receiving treatment had a reduction in their tremor severity after 89.5% of the treatment sessions as measured by the sensors. Physicians assessed the severity of tremor in the entire arm and the assessments showed a 65% improvement in the treatment group compared to 32% in those who received sham stimulation. Participants also rated their performance on tasks of daily living performed in the clinic before and after stimulation. Patients in the treatment group had a 27% improvement compared to 16% in the sham control group. Overall, 88% of those receiving the treatment reported improvement in their tremor after receiving treatment stimulation.

These are combined results from an in-clinic study of 77 participants and the an at-home study of an additional 61 participants. All participants had essential tremor and were randomized to a treatment group or a sham control group. The device delivered a stimulation pattern tuned to interrupt a person's tremor. Patients received neuromodulation or sham treatment on the wrist of whichever one of their hands had more severe tremor.

"The study conducted in the clinic showed that treatment stimulation was safe and produced significant improvements in both physician-rated and patient-rated measures of tremor severity compared to sham stimulation," said study author Rajesh Pahwa, MD, FAAN of the University of Kansas Medical Center in Kansas City.

Participants had no serious side effects, and only 3% of patients in the in-clinic study had mild side effects such as skin redness and irritation, which resolved spontaneously.

For the at-home study, 61 participants received either treatment stimulation, sham stimulation, or their usual treatment. Those who received treatment stimulation had a minimum of 2 sessions a day for up to 1 month.

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