Cala Health Trio, Руководство для пациента

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LBL-5117 Rev C AUG 2019
8.0
CLINICAL STUDY SUMMARY
A multi-center, prospective, randomized, double-blinded,
sham-stimulation controlled study was conducted to assess
the safety and effectiveness of the Cala device to aid in
the transient relief of hand tremors in adults with essential
tremor. The study enrolled 93 patients across four US sites.
Each patient was seen for a single three-hour appointment
at a study site. Patients were randomized one-to-one to
either the investigational stimulation (“treatment” group)
or sham stimulation (“sham” group). The stimulation
amplitude for the treatment group was based on each
patient’s stimulation threshold. The sham group received
0-amplitude stimulation. The study site personnel and
investigator were not blinded and knew the patient’s
therapy allocation. However, the patient and the raters
assessing the effectiveness were blinded.
The patients’ tremor severity was assessed before, during,
and immediately after the 40-minute stimulation session
using various metrics, such as spiral drawings and activities
of daily living (ADLs). Patients had an improvement
in tremor severity, as well as an improvement in ADLs
compared to baseline. However, there was a lack of
statistical significance between treatment and sham groups
for both tremor severity and ADLs.
Safety was assessed using adverse event data collected
during the study. Three percent (3/93) of enrolled patients
experienced four non-serious adverse events (one patient
reported two adverse events). The four adverse events
were mild, anticipated, and resolved within 24 hours without
any intervention or sequelae, specifically, weakness, skin
irritation, and pain (reported in a sham patient).