Cala launches wearable to treat hand tremor in Parkinson's
US bioelectronics company Cala has formally launched its wristwatch-like Cala kIQ device to relieve hand tremors in people with Parkinson’s disease, adding to its current use in essential tremor.
The FDA-approved wearable provides temporary relief to patients with action tremor of the hand, the shake that occurs with the intentional movement of a muscle, by applying neuromodulation to nerves in the wrist using transcutaneous afferent patterned stimulation (TAPS). It is the “first and only” FDA-cleared wearable device for this indication, according to the company.
Action hand tremor can make simple activities like holding a cup, unlocking a door, or using a phone challenging and frustrating for patients.
Essential tremor is one of the most common movement disorders in adults, affecting around seven million people in the US, while Parkinson’s is diagnosed in around a million people in the US. Drugs like beta blockers and propranolol can provide relief to some patients with hand tremor, but use is often limited by side effects, and neurosurgical therapies like deep brain stimulation (DBS) can be hard to access.
As a non-invasive, non-pharmacological therapy, Cala kIQ provides an alternative that puts the patient in control and avoids the side effects of traditional therapies. It was first approved for essential tremor last year, and can now be used in Parkinson’s patients as well.
According to Cala, the device measures each patient’s tremor physiology, analyses it using artificial intelligence, and sends an individualised stimulation pattern to counteract the errant nerve signals. It connects to a patient portal that allows users to see their therapy results over time and choose to share the data with their doctors.
The efficacy of the wearable is supported by the PROSPECT-1 clinical trial, involving more than 200 patients with essential tremor, which demonstrated a reduction in symptoms in 92% of patients over three months of follow-up.
More than half of the patients (54%) saw an improvement in the strength of tremors of 50% or more, and two-thirds of those reporting moderate or severe symptoms at baseline said they had mild or slight symptoms by the end of the study.
The PROSPECT-1 results were subsequently backed up by a real-world study that showed that 84% of patients experienced tremor reduction and 43% of patients had a 50% reduction after a single month of therapy.
“Current research shows that tremors can severely impact patients’ mental health and activities of daily living,” commented Pravin Khemani, a neurologist at Swedish Neuroscience Specialists in Seattle.
“There’s a real need for patient populations who suffer from action hand tremors to have an effective, safe option when it comes to managing their symptoms.”
The challenge for Cala now is to develop a commercial market for the device, and to that end the company says it already has an agreement with the US Department of Veterans Affairs (VA) health systems to provide the device at no cost to its beneficiaries, along with other health plan contracts covering essential tremor.
The company said it is working to secure additional coverage and reimbursement for the Parkinson’s disease indication.