Cala Health last month launched a clinical trial of the latest version of its wearable neurostimulator for treating essential tremor, eyeing extended use of the wrist-worn device.
The Burlingame, Calif.-based company won de novo clearance from the FDA last April for the Cala One device for transient relief in adults with essential tremor. The 500-patient, single-arm Prospect trial is designed to evaluate the Cala Two device for symptomatic relief for three months, with patients undergoing two daily treatments of 40 minutes each, separated by at least two hours.
Prospect’s primary outcomes include the subset score using the Tremor Research Group’s Essential Tremor Rating Assessment Scale, which rates six tasks from zero to four, with a higher score indicating more severe tremor; and the subset score using the Bain & Findley Activities of Daily Living, which rates eight tasks on the same 0-4 scale, according to ClinicalTrials.gov. Secondary outcomes include changes in kinematic measurements collected by Cala Two during postural holds. The study’s primary completion date is set for June, with an estimated completion date in September.
The first patients were enrolled in December 2018 at the University of South Florida Morsani College of Medicine in Tampa and USC’s Keck School of Medicine in Los Angeles, Cala Health said.
“People with essential tremor have their daily routine constantly disrupted and are looking for ways to control it,” Keck’s Dr. Mark Lew said in prepared remarks. “Our study aims to explore electrical stimulation via wearable therapy in the hopes of providing relief for those experiencing essential tremor.”
“The Prospect study will expand our understanding of patient benefit of CALA TWO by studying its therapeutic effect over a three-month period,” added Dr. Theresa Zesiewicz of the University of South Florida. “This therapy holds the promise to increase accessibility of an effective, non-invasive treatment option for hand tremors.”