For the second study, conducted for 4 weeks, 61 patients were randomized to at-home treatment sessions with the neuromodulator or sham treatment for 40 minutes at least twice daily. Those receiving treatment (n = 31) saw greater reduction in tremor measured by the devices’ built-in sensors, compared with those assigned sham treatment (n = 15) or no treatment (n = 15). Nearly all sessions completed resulted in a measurable reduction of tremor.
In an interview at AAN, Manish Gupta of Cala Health, the device manufacturer, said that further studies are underway to assess the durability of the treatment.
“What we seem to be looking at is an on-demand therapy that delivers a transient relief,” Mr. Gupta said, adding that the devices could be used by patients at times when their tremor is most bothersome, or in anticipation of a task – such as dressing oneself or eating – that a tremor would affect the ability to perform.
“One thing we’re learning from clinicians is that tremor is variable within the patient, and it’s variable across patients,” Mr. Gupta said. “The same patient may find that they have less tremor a certain day or at certain times of the day. We don’t think this would replace deep-brain stimulation, which is a constant treatment effect, but it could serve for some patients as a step before it.”
Cala Health, the manufacturer, sponsored the study. One coauthor is an employee of Cala Health.
SOURCE: Pahwa R et al. AAN 2018, Abstract P4.474.