Clinically validated. Meaningful tremor relief.
The Cala kIQ™ System with TAPS (Transcutaneous Afferent Patterned Stimulation) therapy is validated by large clinical studies and real world evidence demonstrating clinically meaningful tremor reduction and improvement in activities of daily living.1,2
Cala kIQ therapy is cleared by the FDA as an external upper limb tremor stimulator, Class II (initially under de novo DEN170028 with subsequent 510(k) clearances K182706, K203288, and K22xxxx).
Effective hand tremor relief, without systemic side effects.
Historically, treatment options for action hand tremors in essential tremor and Parkinson’s disease have been limited. Prescription medication has generally been first line therapy, but patient responses can vary, often with unwanted side effects. There are surgical options for people with severe tremor, but many don’t want invasive surgery.
That’s why we created the Cala kIQ System, a safe, effective treatment that uses TAPS, or transcutaneous afferent patterned stimulation, to treat action hand tremor for essential tremor and Parkinson’s disease. The Cala kIQ device non-invasively stimulates the peripheral nervous system via a wrist-worn device. The technology draws upon research behind deep brain stimulation (DBS) where studies have identified the ventral intermediate nucleus of the thamalmus (VIM) as a key target for controlling tremor.3,4 TAPS therapy is designed to override or disrupt the pathological oscillations at the VIM reducing action hand tremor. But while DBS is an invasive procedure, TAPS therapy is non-invasive. It’s an innovative solution that many patients prefer over current treatment options, and helps you improve your patients’ quality of life.1
1. Isaacson SH, et al. Tremor and Other Hyperkinetic Movements. 2020;10:29. doi:10.5334/tohm.59. As measured by Cala device following three months of repeated home use in 205 patients with essential tremor who completed the study. Many participants were also taking medication for their tremor and it was difficult to assess the effect of the device compared to medication.
2. Brillman S, Colletta K, Borucki S, Lin PT, Waln O, Petrossian M, et al.. Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor. Tremor and Other Hyperkinetic Movements. 2022;12(1):27
3. Milosevic L, Kalia SK, Hodaie M, Lozano AM, Popovic MR, Hutchison WD. Physiological mechanisms of thalamic ventral intermediate nucleus stimulation for tremor suppression. Brain. 2018 Jul 1;141(7):2142-2155. doi: 10.1093/brain/awy139. Erratum in: Brain. 2018 Sep 1;141(9):e72. PMID: 29878147; PMCID: PMC6022553.
4. McIntyre CC, Hahn PJ. Network perspectives on the mechanisms of deep brain stimulation. Neurobiol Dis. 2010 Jun;38(3):329-37. doi: 10.1016/j.nbd.2009.09.022. Epub 2009 Oct 3.PMID: 19804831; PMCID: PMC2862840.
The Cala kIQ System makes it easy.
When you prescribe the device, Cala’s Customer Care team becomes your patient’s point of contact — from working with them through the insurance process, to helping them learn how to use the device, and answering any questions they have.
The Cala kIQ System empowers clinicians and patients with objective data. The device securely sends therapy data to the MyCala.com Patient Portal where patients can view and share their individualized therapy insights and see their results over time.
Patients can use the Cala kIQ System as needed. The device sends data to the cloud, which can be viewed by patients on the MyCala.com Portal. Patients can share their individualized therapy insights and see their results over time.
Please review full safety information here.
How TAPS Therapy Works
The PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy (PROSPECT), n=231, across multiple sites, was conducted using Cala TAPS technology. The data showed that TAPS therapy is a safe and effective treatment option for tremor relief.1
64% of patients reported having persistent relief, lasting for an average of 94 minutes1*
People experience reduction with a complete 40-minute session1
Of patients who self-rated as having “Severe or Moderate” difficulty in their activities of daily living self-rated as “Mild” or better at the end of the study1
Of patients experienced improvement in holding a cup of tea1
Of patients reported improvement in dialing a telephone1
*Median= 60, standard deviation = 138
1. Isaacson SH, et al. Tremor and Other Hyperkinetic Movements. 2020;10:29. doi:10.5334/tohm.59. As measured by Cala device following three months of repeated home use in 205 patients with essential tremor who completed the study. Many participants were also taking medication for their tremor and it was difficult to assess the effect of the device compared to medication. Percentage patient improvement defined as % patients improving at least one one increment (0.5 or 1, depending on scale and task).
Safety information.
Review the Cala kIQ device’s safety information for more on indications for use, warnings, and side effects.
92% of patients showed improvement.
Many patients had between 55-90% reduction in tremor
Per-patient tremor power* reduction demonstrated in home-use therapy sessions
*Tremor power is a calculation of amplitude and frequency. Tremor power decreases with lower amplitude motions and lower frequency motions.
Isaacson SH, et al. Prospective Home-use Study on Non-Invasive Neuromodulation Therapy for Essential Tremor. Tremor J. 2020;10:29. As measured by Cala device following three months of repeated home use in 205 patients with essential tremor who completed the study. Many participants were also taking medication for their tremor and it was difficult to assess the effect of the device compared to medication.
Clinical trial evidence is vital, but it’s also crucial to look at how the device works in real life. “Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor” was a retrospective post-market surveillance analysis, with usage and effectiveness data gathered through device logs1.
The analysis evaluated the real-world effectiveness of Cala TAPS therapy from August 2019 to June 2021.
- N=321 users included in the demographics and usage analysis
- N=216 users met the analysis criteria for effectiveness
- N=69 users participated in the voluntary survey
1. Brillman et al. Tremor and Other Hyperkinetic Movements, 2022;12(1), 27. DOI: http://doi.org/10.5334/tohm.715
The findings.
The findings clarified how patients use the device on-demand, in the real world.
Usage, based on patient choice, happened an average of 5-6 times per week (mean = 5.4), with at least 20 minutes per session.
The evidence further supports previous effectiveness findings from PROSPECT.
Tremor power decreased by 3.5-fold (71% reduction, p < 0.001) with nearly 1 in 3 patients experiencing a 75% reduction.
Evidence suggests no habituation over an 18 month period.
Tremor power reduction for patients in the first 90 days were similar to those beyond 90 days, and there was no statistical difference in habituation in the patients who used therapy for one year or more.
65% of patients self-reported improvement in quality of life.
Most patients who responded to the survey also reported improvement in at least one important activity of daily living: eating (74%), drinking (65%), or writing (64%). 65% of patients indicated a preference for TAPS therapy over medication and surgery for tremor management. Of the patients who were on tremor medication beforehand, 24% of them reduced their medication and 14% discontinued medication after 90 days.
Peer-reviewed, clinical evidence.
TAPS therapy is a clinically proven treatment to provide temporary relief from hand tremors in essential tremor patients, allowing them to manage daily activities with more ease.
Real people. Real results.
Thousands of people are using Cala TAPS therapy. Hear from real users how it has made a difference.
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