Using Cala Health’s non-invasive therapeutic device Cala Trio for 40 minutes twice daily effectively helped to reduce hand tremors within three months, results from a clinical study show.
The results, “Study Design, Baseline Demographics, and Interim Results from the Prospective Study for Symptomatic Relief of Essential Tremor with Cala Therapy (PROSPECT) Trial” (LBA No. 9), were presented at the International Congress of Parkinson’s Disease and Movement Disorders in Nice, France.
Cala Trio is a wrist-worn device that delivers neuromodulation therapy, calibrated to individual needs, through the skin to provide symptomatic relief of hand tremors. The device gently stimulates the nerves responsible for the tremor, interrupting nerve circuits to allow for better control of movement.
“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 essential tremor, without surgery or drugs,” Kate Rosenbluth, founder and chief scientific officer at Cala Health, said in a news release. “We are deeply grateful to the patients and investigators who participated in this study.”
The PROSPECT trial (NCT03597100) claims to be largest study conducted in patients with essential tremor, a benign neurological condition that is characterized by uncontrolled, rhythmic shaking, typically in the limbs. The trial enrolled 263 people at 26 U.S. sites; all had essential tremor symptoms for an average of more than 25 years (median age at study, 69.6).
Essential tremor — often misdiagnosed as Parkinson’s disease — is a progressive movement disorder most common in people ages 40 and older. It mainly affects the hands and arms, but head, voice, and leg tremors are also known.
Unlike Parkinson’s, which is associated with motor symptoms such as slow movement and muscle stiffness, essential tremor does not cause other health problems, although unsteady gait may be observed. Parkinson’s patients also typically experience tremors when their hands are at rest, while essential tremor is evident when people are using their hands.
Trial data showed that, for a majority of these people, using Cala Trio in 40-minute sessions twice daily for three months effectively reduced hand tremor severity. The average symptom relief lasted 96.7 minutes after each stimulation session — done at least two hours apart — in patients reporting benefits.
In total, 62% of participants improved from severe or moderate tremors to mild or slight tremors, according to the physician-reported Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS); 68% said their tremors went from severe or moderate before treatment to mild after Cala Trio use, according to results of the self-reported Bain and Findley Activities of Daily Living (ADL) scale.
Overall, 54% of patients reported a greater than 50% reduction in tremor power after finishing the study’s three months of treatment, and 25% experienced a 70% easing in tremor power, the study reports.
Participants also reported significant improvement in Quality of Life in Essential Tremor Questionnaire (QUEST) scores by study end.
“For patients living with ET [essential tremor], 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.
“Treatment with Cala Trio represents a novel approach to improving tremor in people living with essential tremor and provides a safe and effective therapeutic option.”
Transient device-related adverse events were reported in 18% of participants, which included wrist discomfort, skin irritation, and pain. None required medical intervention.
Cala Trio has been cleared by the U.S. Food and Drug Administration to treat essential tremor, and is currently available by prescription in select U.S. markets.