Who is it for?
Cala Trio therapy is available by prescription for patients diagnosed with essential tremor.
How does it work?
Cala Trio therapy is the first and only wrist-worn medical device designed to treat the source of the hand tremor by gently stimulating the wrist nerves with electricity, also known as neuromodulation, and targeting the root cause of the essential tremor.1
The Cala Trio device is FDA-cleared, safe, effective, and individually calibrated to each patient's unique brain signal pattern.2
Can I try it?
Cala is committed to ensuring all patients have access to Cala Trio therapy. If you and your prescriber decide that Cala Trio therapy is not right for you, simply return the device before the end of the 60-day return period, and you will not be held responsible for any costs.*
*Patient agreement is required; patients using Medicare benefits are not eligible.
Clinical Evidence
Experience meaningful temporary tremor relief after a 40-minute treatment session with Cala Trio therapy.
71% of patients-reported improvement in holding a cup of tea in Activities of Daily Living.1
64% of patients reported persistent relief for an average of 94 minutes (standard deviation = 138; median = 60).1
68% 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 study. Patients reported using Bain-Finley Activities of Daily Living (BF-ADL).1
72% of patients-reported improvement in unlocking the front door in Activities of Daily Living.1
Real World Evidence
Data analyzed from 22 months of real world use confirms prior clinical studies showing Cala Trio therapy effectively reduces tremor with no loss of effect over time and improves patient quality of life for those living with essential tremor.3
Contraindications: Cala Trio therapy should NOT be used by patients with an implanted electrical medical device, those with suspected or diagnosed epilepsy or other seizure disorders, or used on the treated wrist with diseased skin (e.g., swollen, infected, inflamed areas, or open wounds), or by patients who are or may be pregnant. Review all safety information before using the Cala Trio therapy, CalaTrio.com/Safety.4
How Do I Get Started?
Talk to your doctor to see if Cala Trio therapy is right for you.
Download the discussion guide to help you and your doctor assess whether Cala Trio therapy is right for you.
Download Patient Discussion Guide
Cala Customer Care will contact you after receiving your prescription from your healthcare provider and confirm your insurance coverage details, including your estimated copay.
Cala Trio therapy will be delivered to your home, and Cala Customer Care will support you with training.**
**Once the Cala Trio device arrives at your home, a 30-minute training session is available.
For the visually impaired, a full text alternative of this video is available here
| Time Frame | Visuals | Voice Over |
|---|---|---|
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0:00 |
Screen Text: Talk to your doctor about Cala Trio |
Background music |
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0:06 |
Video clips of patient struggling to do everyday tasks. |
Essential tremor is a benign yet life-altering condition that impairs performing day-to-day activities. Although onset typically occurs in adults fifty and older, symptoms may appear much earlier in life. |
|
0:20 |
Background: Patient reading a book then looking at a computer screen Screen Text: Non-invasive treatment for essential tremor |
Cala Trio, is a wrist-worn, non-invasive treatment for essential tremor. It targets the tremor network with peripheral nerve stimulation through the wrist. |
|
0:30 |
Background: Patient looking at a computer screen then visiting her doctor Screen Text: Requires Prescription Background: Screen of a search engine typing in URL |
Cala Trio therapy is a prescription device. Your physician may not know about Cala Trio therapy, its clinical results, or that it is now available! Forward the link calatrio.com/healthcare-professionals to your doctor so he/she can learn more prior to your appointment. |
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0:50 |
Background: Patient looking at a computer visiting calatrio.com to download a Doctor Discussion Guide Screen Text: Requires Prescription Background: Screen of a search engine typing in URL |
The website has a lot of information about essential tremor and Cala Trio. If you think Cala Trio might work for you, simply download and print the Doctor Discussion Guide which includes a prescription form for your doctor. Complete the guide to give your doctor basic background information about your experiences with tremor. |
|
1:09 |
Background: Patient visiting her doctor with Doctor Discussion Guide Screen Text: How long have you had hand tremors? Has medication worked? Do you have the relief you want? |
Remind your doctor about your experiences with therapies. How long have you had hand tremors? How has medication worked? Do you have the relief you want? |
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1:19 |
Background: Patient visiting her doctor with Doctor Discussion Guide with her hand shaking Screen Text: “I found a new therapy for my essential tremor and want to see if you will write a prescription for it so I can Try it.” |
Tell your doctor, “I found a new therapy for my essential tremor and want to see if you will write a prescription for it so I can try it. Here is some information about Cala Trio therapy.” It is easy for your doctor to prescribe Cala Trio. |
|
1:33 |
Background: Patient showing her tremors to doctor Images: Two hand Icon Screen Text: Select right or left hand |
There are 3 simple parts of the prescription to discuss with your doctor Select the hand you want to treat that will provide the most relief for your lifestyle. |
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1:42 |
Background: Patient getting her wrist measured Images: Measuring tape icon Screen Text: Determine wrist size |
Measure your wrist to determine band size. |
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1:45 |
Background: Patient doing tremor task positions Images: Icons for the two tremor positions Screen Text: Outstretched Wing beating |
Choose the tremor task that elicits the more significant hand tremor. Hold your hands stretched straight in front of you. Bend your arms to the side in the ‘wing-beating’ pose. Determine which of these postures gives you a more significant tremor. Your doctor will fax the prescription to Cala Health. |
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2:02 |
Background: Patient opening a Cala Trio box Screen Text: Your Cala Trio will arrive in a few days |
Once ordered, your Cala Trio will arrive in a few days |
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2:07 |
Background: Patient on the phone holding Cala Trio Screen Text: CustomerSuccess@CalaTrio.com |
Meet with our customer success team via phone or video to set-up your Cala Trio. |
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2:13 |
Background: Patient showing tremor reduction enjoying activities of daily living |
Enjoy a reduction in your hand tremor. Talk to your doctor about incorporating Cala Trio therapy into your treatment for essential tremor. |
|
2:23 |
Background: Cala trio on docking station with logo Screen Text: calatrio.com Federal law restricts this device to sale by or on the order of a physician. Please refer to the labeling for a complete list of warning, precautions and contraindications. |
Background music |
Common Questions
We have provided a downloadable guide to help you talk to your doctor about Cala Trio therapy.
First off, help is right at your fingertips. Available 24 hours/day, we have a number of resources, from the Patient Guide to product videos, on my.calatrio.com. In the Patient Guide, review the Troubleshooting section to see details on how to address specific warning messages.
What support will Cala Health provide to help me with Cala Therapy?
Cala Customer Success provides support, direct to you! We contact you when your device ships to see if you would like assistance with set up and calibration.
Should you need further help, contact Cala Customer Success at 888-699-1009 and Customer Success@CalaTrio.com. We are available from Monday to Friday, 7am-4pm Pacific Time.
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In the clinical trials, subjects used Cala Trio while taking their medication for essential tremor.
It is best to discuss your therapy options with your physician.
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During set up, Cala Therapy is calibrated by having you perform your prescribed “Tremor Task” three times. This allows the device to characterize your tremor and individualize the stimulation. The accelerometers in the device measure your motion and determine the best pattern to deliver the stimulation.
What do the buttons on Cala Therapy do?
There are three buttons, MAIN, UP, and DOWN that control the main operation of the stimulator. The buttons are used to set up the device, calibrate, and start, stop, or adjust intensity during a therapy session. Please refer to the Patient Guide for full description of the button functionality.
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- 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.
- Food and Drug Administration (FDA) cleared as de novo DEN170028 with subsequent 510(k)s: K182706 and K203288.
- 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.
- Safety information. The most common reported side effects include mild to moderate skin irritation, including electrical stimulation burns, redness, and/or itching where the device touched the skin. For comprehensive safety information, visit CalaTrio.com/Safety.
- Patient experiences are summarized from interviews featured on the Cala Health YouTube Channel. Individual results may vary; patients were not compensated for their stories.
