Patient recruitment is usually the biggest challenge in conducting clinical trials. Thanks to the International Essential Tremor Foundation and their members, Cala Health recently enrolled the largest therapeutic essential tremor study in record time.
By Kate Rosenbluth,
Founder/CEO of Cala Health, Inc.
About five years ago, my co-founders and I spun Cala Health out from Stanford University to develop a wearable therapy for essential tremor. We spent several months observing and interviewing patients, neurologists and neurosurgeons, and were captivated by the unmet need to give people back their hand control without undergoing brain surgery. The International Essential Tremor Foundation and its members gave generous time to helping us understand the condition and how we could help. We formed a company and began product development of a peripheral stimulation device worn on the wrist to interrupt the tremulous signal driving the tremor in the brain.
Our careful research and development process brought us to the final stage, clinical trials. Clinical trials produce the most reliable data available for health care decision making. They follow strict scientific standards to protect patients and produce dependable study results. Oftentimes, the single greatest challenge in conducting a successful clinical trial is recruiting participants. Typically, most participants are recruited by physicians serving as Principal Investigators for the study, or by engaging advertising agencies to inform potential participants that a clinical trial is available. This can take months, if not years, and require significant investment in advertising.
Fortunately, Cala Health has partnered with the International Essential Tremor Foundation, who announced this research opportunity to their members nationwide. We immediately received interest from qualified participants who have been struggling with essential tremor for years and connected them with the leading neurologists in movement disorders who were participating in our trial. We have been so pleased with the response. Most recently, this generated and enrolled hundreds of patients into our PROSPECT study in record time. During the study, patients wore the therapy on their wrist like a smart watch and patterned electrical stimulation was delivered to the nerves through the skin twice per day over a three-month period. This fast enrollment enables a key milestone to share the results later this year and make this FDA-cleared therapy commercially available.
People who take part in clinical trials are vital to the process of improving medical care. IETF is an essential partner to Cala Health informing the ET community of the clinical research opportunities to advance medical knowledge and patient care.
About Cala Health, Inc.
Cala Health is a bioelectronic medicine company transforming the standard of care for chronic disease. The company’s wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation. The first indication for Cala Health’s wearable therapy is essential tremor, a disease experienced by more than seven million people and characterized by severe hand tremors. Visit www.CalaTrio.com to learn more. New therapies are under development in neurology, cardiology and psychiatry. The company is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology.