Bioelectronic medicine company, Cala Health, Inc. says its landmark PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy (PROSPECT), demonstrates safe and effective hand tremor reduction and improved quality-of-life for adults with essential tremor (ET) over three months.
Background
Essential Tremor (ET) is the most prevalent tremor disorder and one of the most common neurological disorders, affecting an estimated seven million people in the United States. It is a chronic condition that causes involuntary and rhythmic shaking and typically worsens over time. ET 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. ET is often confused with Parkinson’s disease, although it is eight times more common. A key difference is that hand tremors caused by ET happen with goal-directed movement (with intention), whereas Parkinson’s disease tremors occur mostly at rest. Current ET treatments include mostly off-label use of medications or brain surgery.
Cala Trio™ is the first non-invasive targeted therapy that reduces hand tremors for adults living with Essential Tremor (ET). Prescription therapy is a simple, wrist-worn device that is calibrated to treat a patient’s unique tremor symptoms. When activated, Cala Trio gently stimulates the nerves in the wrist to disrupt the tremulous activity in the brain, without the need for invasive brain surgery or medication.
As the largest therapeutic clinical trial in ET, the PROSPECT study, published in Tremor and Other Hyperkinetic Movements, enrolled 263 patients across 26 sites. Study patients used the therapy twice daily for three months – overall, collecting more than 21,000 stimulation sessions. The unique study met both its co-primary and secondary endpoints with 62% and 68% of ‘severe’ or ‘moderate’ patients improving their tremor amplitude to ‘mild’ or ‘slight,’ measured using the validated physician-rated scale (TETRAS) and validated patient-rated Bain & Findley Activities of Daily Living (BF-ADL), respectively. Clinical and Patient Global Impression scores showed 68% of clinicians and 60% of patients reported improvement in the severity of their tremors. In Quality of Life in Essential Tremor (QUEST) surveys conducted after three months of use, patients indicated their quality of life improved (p=0.0019). This manuscript includes all data previously presented at recent clinical meetings.
Company comments
“ET is one of the most common movement disorders among adults. It can be physically and psychologically draining while reducing the quality of life for these patients,” said Renee Ryan, Chief Executive Officer of Cala Health.
“The PROSPECT study publication confirms that Cala Trio therapy is a safe and effective treatment option and, most importantly, shows the improved quality of life for these ET patients. These findings, consistent with those demonstrated in previous trials against sham, will be leveraged to support our reimbursement initiatives, leading to improved access for patients living with essential tremor.”
Source: Businesswire
published: August 18, 2020 in: Clinical Studies/Trials, Neuro