In the PROSPECT study (NCT03597100), a wrist-worn neuromodulation device (Cala Trio; Cala Health, Inc.) provided symptomatic relief for essential tremor (ET).
Tremor severity, as measured by The Essential Tremor Rating Assessment Scale (TETRAS), improved from severe/moderate to mild/slight for 62% of participants. Using the Bain & Findley Activities of Dailey Living (ADL) scale, 68% of participants had improved tremor severity from severe/moderate to mild over a 3-month period.
Tremor power was also measured with motion sensors, and 54% of participants experienced more than 50% improvement in tremor power for the 3-month study.
Average symptom relief lasted 96.7 + 12 minutes after each stimulation session for participants who reported benefit.
“In the prospective PROSPECT trial, we found that 68% of patients showed significant improvement in hand tremor after wearing the Cala therapy for 3 months, as measured by the ADL assessment scale,” said Stuart Isaacson, MD, director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton. “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. For patients living with ET, this means that they can now more easily complete daily tasks.”
The study enrolled 263 participants with an average duration of ET symptoms of more than 25 years. Participants were instructed to use the device for 40-minute sessions, twice daily for 3 months.