Cala Health Inc, a bioelectronic medicine company developing wearable therapies for chronic disease, presented positive topline data from the landmark PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy (PROSPECT) at the International Congress of Parkinson's Disease and Movement Disorders. Cala Therapy, now marketed as Cala TrioTM, is available by prescription in the United States. This wrist- worn neuromodulation therapy is the only non-invasive individualized therapy for essential tremor (ET). For more information see the IDTechEx report on Wearable Technology Forecasts 2019-2029.
PROSPECT is the largest therapeutic trial ever conducted for ET, the most common tremor disorder, affecting over seven million people in the United States. The study met its co-primary and secondary endpoints, achieving statistically significant improvements in symptomatic relief of ET in the treated hand at three months compared to baseline. Symptomatic relief was measured using multiple ratings, including The Essential Tremor Rating Assessment Scale (TETRAS), a physician rating, (p< 0.0001) and Bain & Findley Activities of Daily Living (ADLs), a patient rating, (p<0.0001). Tremor power was measured using motion sensors (p< 0.0001). No device- related serious adverse events were reported.
"In the prospective PROSPECT trial, we found that 68% of patients showed significant improvement in hand tremor after wearing the Cala Therapy for three months, as measured by the ADL assessment scale. For patients living with ET, this means that they can now more easily complete daily tasks such as handwriting, drinking from a glass, and using a soup spoon - tasks that were otherwise much more difficult," said Stuart Isaacson, MD, Director of the Parkinson's Disease and Movement Disorders Center of Boca Raton in Florida. "The therapy is calibrated to each patient's hand tremor. When activated, it gently stimulates the nerves at the wrist, which interrupts the tremulous circuit in the brain and results in tremor reduction. Treatment with Cala Trio represents a novel approach to improving tremor in people living with ET and provides a safe and effective therapeutic option."
PROSPECT was a prospective, 26-center, single-arm study designed to evaluate the symptomatic relief from hand tremor in ET with repeated use of Cala Therapy. Patients were instructed to use the device for 40-minute sessions twice daily for three months. The device was calibrated to each patient's tremor frequency and delivered patterned electrical stimulation to nerves through the skin. The study enrolled 263 patients with an average duration of ET symptoms lasting over 25 years.
Data show 62% of patients improved in tremor severity from severe/moderate to mild/slight according to TETRAS and 68% of patients improved in tremor severity from severe/moderate to mild according to ADLs (baseline vs. three months). The average symptom relief lasted 96.7 + 12 minutes after each stimulation session for patients that reported benefit.
"We are thrilled with the results of the PROSPECT trial. It is tremendously exciting to see the relief our non- invasive neuromodulation therapy brings to patients with ET, without surgery or drugs," said Kate Rosenbluth, Founder and Chief Scientific Officer at Cala Health. "We are deeply grateful to the patients and investigators who participated in this study." For more information see the IDTechEx report on Bioelectronic Medicine 2019-2029.
Source and top image: Cala Health
Learn more at the next leading event on the topic: Healthcare Sensor Innovations USA 2020 on 17 - 18 Mar 2020 at San Jose, USA hosted by IDTechEx.