FDA Grants Breakthrough Device Status to External Neuromodulator for Essential Tremor

The Food and Drug Administration (FDA) has granted a breakthrough device designation to a wrist-worn neuromodulation device (Cala Trio; Cala Health, Inc, Burlingame, CA) for external neurostimulation treatment to reduce action tremors in adults with Parkinson disease (PD). The device is currently FDA-cleared to relieve hand tremors from essential tremor (ET). 

". . .hand tremor in patients living with PD typically occurs when the arm is at rest while sitting or walking, it is also estimated that more than half of patients also experience action tremor, which occurs when the arm is being used to perform an activity or task," said Stuart Isaacson, MD, director of the PD and Movement Disorders Center of Boca Raton in Florida. "Furthermore, published data suggest that levodopa, the primary treatment for motor symptoms of PD, is not usually effective in treating this type of tremor, which can negatively affect performing daily tasks like eating and writing. For this reason, treatment for action tremor in patients with PD a significant unmet medical need that impacts their daily activities and overall quality of life."

In a prospective clinical trial (NCT03597100), participants were instructed to use the device for 40 minutes twice daily for 3 months. In this trial, 60% or more of participants who used the device had improvement in clinical and global impression scores (both patient and clinician ratings). Wrist-worn accelerometer recordings before and after 21,806 therapy sessions showed that 92% of participants improved. 

New trials, which will be conducted via telemedicine, for individuals with PD are set to begin in the fourth quarter of 2020. Physicians and patients with PD-related action hand tremors interested in participating are encouraged to visit CalaHealth.com/research. Virtual clinical trials will allow participants to volunteer from home, using the therapy as indicated in the study design and having telemedicine visits with a neurologist throughout the study.

"Cala Health is committed to pursuing rigorous scientific and clinical research to demonstrate the mechanism, benefits, useability, and safety of our technologies," said Kate Rosenbluth, PhD, founder and chief scientific officer of Cala Health. "We are pleased to have the FDA recognize the novelty and potential for our wrist-worn neuromodulation therapy."

In the trials done to date, device-related adverse events, including wrist discomfort, skin irritation, or pain occurred in 18% of participants. No device-related serious adverse events were reported.