By Amy Widner
Researchers from the University of Arkansas for Medical Sciences (UAMS) participated in the largest therapeutic trial ever conducted in essential tremor, called the PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy (PROSPECT).
The landmark study found that nerve stimulation with Cala Therapy can significantly reduce hand tremors. Topline results from PROSPECT were presented Sept. 25 in a late-breaking poster presentation at the International Congress of Parkinson’s Disease and Movement Disorders in Nice, France.
Cala Therapy, now marketed as Cala TrioTM, is a wrist-worn neuromodulation therapy that provides symptomatic relief of essential tremor in the hand. Essential tremor is the most prevalent tremor disorder and one of the most common neurological disorders, affecting about seven million people in the United States. It can affect almost any part of the body, but the trembling most often occurs in the hands, making everyday activities such as eating, writing or getting dressed extremely difficult. Current essential tremor treatments include mostly off-label use of medications or brain surgery.
“We are proud to be at the forefront of essential tremor research and part of the largest therapeutic trial in this chronic and progressive disease,” said Rohit Dhall, M.D., MSPH, lead investigator for the PROSPECT trial at UAMS. “Non-invasive treatment with Cala Trio represents a novel approach to managing hand tremor, and more importantly, it provides patients with a safe and effective therapeutic option to surgery or drugs.”
“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,” said Kate Rosenbluth, founder and chief scientific officer at Cala Health. “We are deeply grateful to the patients and investigators at UAMS who participated in this study.”
Patients at 26 locations participated in the PROSPECT trial. They used Cala Therapy 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 essential tremor symptoms lasting over 25 years.
Sixty-eight percent of clinicians and 60% of patients rated improvement at three months. Data show 62% of patients improved in tremor severity from severe/moderate to mild/slight.
Significant improvement was also reported in Quality of Life in Essential Tremor Questionnaire scores. Transient device-related adverse events such as wrist discomfort, skin irritation, or pain occurred in 18% of patients. None required medical intervention.
Essential tremor is a chronic condition that causes involuntary and rhythmic shaking and typically worsens over time. It can affect almost any part of the body, but the trembling most often occurs in the hands, making everyday activities extremely difficult. Essential tremor is often confused with Parkinson’s disease, although it is eight times more common. A key difference is that hand tremors caused by essential tremor happen with goal-directed movement (with intention), whereas Parkinson’s disease tremors occur mostly at rest.
Cala Health is a bioelectronic medicine company headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology. For more information, visit www.CalaHealth.com.