NeuroVoices: Kate Rosenbluth, PhD, on Expanding Noninvasive Treatment for Essential Tremor With Cala kIQ Plus

The FDA recently cleared Cala kIQ Plus, an updated, wrist-worn transcutaneous afferent patterned stimulation (TAPS) system, for the temporary relief of action hand tremor in essential tremor (ET) and postural and kinetic tremor symptoms in Parkinson disease (PD). Developed by Cala Health, the device was authorized through the 510(k) pathway on the basis of substantial equivalence to its predecessor, with improvements centered on software, calibration capabilities, and overall usability rather than new pivotal clinical efficacy data.¹

More recently, the company presented new data evaluating different stimulation patterns of its TAPS therapy, including standard stimulation, burst frequency variation, and pulse frequency variation, in patients with ET at the 2026 American Academy of Neurology (AAN) Annual Meeting, held April 18–22 in Chicago, Illinois. Across a series of studies, findings from the analysis showed that all stimulation modes were associated with statistically significant reductions in tremor severity, suggesting that variability in stimulation parameters may be associated with enhanced clinical response.

In a new iteration of NeuroVoices, neuroscientist Kate Rosenbluth, PhD, president and co-founder at Cala Health, outlined the mechanism, clinical utility, and supporting evidence for the Cala kIQ Plus at AAN 2026. She highlighted its adaptive calibration technology and reviewed a growing body of clinical and real-world evidence demonstrating its sustained efficacy without habituation. Rosenbluth also emphasized the device’s role as a noninvasive option that can be used alone or alongside pharmacologic and surgical treatments, addressing an unmet need for patients with functionally impairing tremor during activities of daily living.

NeurologyLive: For clinicians treating patients with ET and PD, can you describe the function of the newly cleared Cala kIQ Plus wearable device and how it is used in clinical practice?

Kate Rosenbluth, PhD: The Cala kIQ Plus is the latest advancement in transcutaneous afferent patterned stimulation. Cala TAPS therapy is a prescription wrist-worn device, and it stimulates the median and radial nerves, and it's indicated for the relief of action tremors in ET and PD. These tremors are incredibly debilitating for patients because they are the tremors that kick in when patients are doing activities of daily living, such as eating, drinking, and writing.

The stimulation from this device goes to the same location in the brain where neurosurgeons implant deep brain stimulation. That was one of the scientific clues that led to our discovery of TAPS. Patients can use the therapy throughout the day whenever they desire. They don't need to stimulate continuously because the device uses adaptive calibration. It's sensing the patient's tremor, it calibrates the device, and that leads to tremor relief enduring after each use of stimulation, so patients also get relief between their sessions.

From a prescribing perspective, what should clinicians understand when discussing this device with patients, and how can they ensure it is prescribed appropriately?

The Cala kIQ Plus is an exciting new innovation for patients. It is a prescription therapy, and the physicians and the patients are supported throughout the journey of the prescription, the review of the documentation for coverage, and then patients are trained and can be brought up on therapy from the comfort of their own home. All of the adaptation and calibration is done onboard the device itself. How do patients use this therapy? They can use it as often as they desire throughout the day. At night, the patients simply put their device on its docking station that charges it. It is also cloud-connected, and conveniently, patients are able to use a portal as well to access additional training materials. They can also see information about their usage, their efficacy, their experience with the therapy, and can also share that information back with their clinician.

What did the clinical data show that led to this device’s approval?

There's a substantial body of evidence on TAPS therapy. There's over 12 studies and 2000 patients that have been evaluated with TAPS. That includes multiple randomized clinical trials, including randomization to sham, as well as randomization to standard of care, multiple mechanism-of-action studies. Some of the most recent studies in the space included a PET imaging study that showed that after months of use, even off stimulation, patients saw changes in the central tremor network in their brain. Recently, also using LFP recordings directly in the thalamus and showing that site engagement and targeting. Also, multiple real-world evidence studies, including evidence showing that even after 3 years of use, patients were using the therapy continuously without habituation. It's really that body of evidence that brought us to where we are at today.

The newest evidence we presented at AAN 2026 and that supported the clearance of this latest device was looking at new technology that adds more adaptive calibration and adds new waveforms. Tremors are naturally dynamically variable, and we hypothesized that by adding variability into the waveforms themselves, you could actually improve the efficacy for patients. The study showed that patients get relief on multiple waveforms. However, if you look at patients on their preferred waveforms that add variability to parameters like the burst frequency and pulse frequency, they do substantially better in key gold-standard metrics like their Bain and Findley Activities of Daily Living.

What are your company’s plans for continuing to innovate and expand the use of this technology moving forward?

We are highly committed to continuing to innovate on behalf of patients with movement disorders. We're very excited about this recent FDA clearance. Development and clinical evidence generation on next generations of the technology are already well underway, and we are also expanding this into some new indications. I'm very excited to come back and share the results of those.

How does this device fit into the management of ON and OFF periods in Parkinson disease, particularly in relation to motor fluctuations?

TAPS therapy is a new therapy offering for the field. Historically, these patients really had 2 options. They could either take medications for ET—the first lines are typically propranolol, an older beta blocker, or primidone, an antiseizure medication—or, on the other end, have the options of brain surgery, of deep brain stimulation, MR-guided focused ultrasound, similarly, for the patients with PD. What's really exciting about this prescription, noninvasive therapy is that it can be used in combination with those or used on its own. There are many patients who are also taking medication.

We are specifically treating the action tremor, and patients are able to use that alongside their medications. These patients have been underserved for so long, especially in key areas like this that really impact their ability to do the things that we take for granted, like eating with a spoon or raising a cup to their mouth. We're just so excited to be offering them another option to get them through those key moments of their day.

Transcript edited for clarity. Click here for more coverage of AAN 2026.

REFERENCES
1. Cala announces FDA clearance of its next generation TAPS therapy wearable device for essential tremor and Parkinson’s disease. News release. Cala Health. April 15, 2026. Accessed April 21, 2026. https://www.prnewswire.com/news-releases/cala-announces-fda-clearance-of-its-next-generation-taps-therapy-wearable-device-for-essential-tremor-and-parkinsons-disease-302742780.html
2. Lu C, Reitmaier S, Kent A, Rosenbluth K. Optimizing Transcutaneous Afferent Patterned Stimulation Therapy: Comparison of Variable Waveforms Reveals Increased Responder Rates and Bilateral Tremor Improvement in Essential Tremor. Presented at: 2026 AAN Annual Meeting; April 18-22; Chicago, Illinois.