How Does Cala TrioTM Work
Cala Trio therapy delivers electrical stimulation to nerves in the wrist. These nerves project from the wrist to central brain networks that are responsible for generating hand tremor in essential tremor. Stimulation of the nerves in the wrist is thought to disrupt the network activity causing hand tremor and provide temporary and meaningful tremor reduction in your treated hand.
Cala Trio provides temporary relief of hand tremors. In our clinical study, it delivered meaningful tremor improvement in 75% of patients after a single 40-minute therapy session. Cala Trio users have described the benefits of therapy as allowing greater ease and ability in their everyday activities. On average, patients demonstrated a 49% reduction in tremor amplitude in Activities of Daily Living like eating with a spoon and holding a full cup of water. However, some patients had as large as an 80% reduction. Use of the device is the best way to assess if Cala Trio is effective for you. (Reference: Pahwa, et al. An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor, Neuromodulation 2019.)
We have limited data from our clinical study to assess this. Many patients in the study were also taking medication for their tremor, and it was difficult to assess the effect of the device compared to medication. Cala Health continues to study Cala Trio therapy to better understand its use and efficacy in these situations.
In our clinical study of Cala Trio therapy (see the Patient Guide for details), participants used the device twice per day. To start, we recommend using Cala Trio in this way for two weeks to understand how therapy works for you and fits into your life. It is designed to provide at least five sessions when fully charged. With experience and input from your physician, you may find the frequency of use that works best for you.
As far as its benefit, therapy resulted in temporary short-term tremor reduction. With a novel technology, first-in-class therapy, Cala Health continues to study Cala Trio therapy to better understand its use and efficacy and will share insight as we learn.
In our clinical studies, subjects had short-term tremor reduction that lasted for up to an hour on average after a single 40-minute stimulation session. With a novel technology, first-in-class therapy, Cala Health continues to study Cala Trio therapy to better understand its use and efficacy and will share insight as we learn. (Reference: Data on-file, publication pending)
Cala Trio therapy is designed for everyday use. The stimulator and base station have an expected service life of 3 years. The band has an expected service life of 90 days. To support everyday use, the stimulator has a 2-year warranty, and the band has a 45-day warranty.
In our clinical study, 75% of patients experienced temporary meaningful symptom improvement after a single 40-minute stimulation session. Individual patient results varied. The average patient demonstrated a 49% reduction in tremor amplitude in Activities of Daily Living like eating with a spoon and holding a full cup of water. However, some patients have greater than an 80% reduction. Use of the therapy is the best way to understand if Cala Trio is effective for any individual patient. (Reference: Pahwa, et al. An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor, Neuromodulation 2019.)
Cala Trio therapy is only indicated to aid in the transient relief of hand tremors in the treated hand following stimulation in adults with essential tremor. Clinical trials have evaluated it in only this use. With a novel technology, first-in-class therapy, Cala Health continues to study Cala Trio therapy to better understand its use and efficacy and will share insight as we learn.
Talk to your doctor. Cala Trio cannot be used if you have a pacemaker, implantable cardiac device, or other implanted electronic device. Please refer to the Safety Information in the Patient Guide for a complete list of warnings and precautions.
Do not use Cala Trio if you have another implanted electronic device. DBS is contraindicated because of the potential risk for interference between Trio and an implanted electrical stimulator. Please refer to the Safety Information in the Patient Guide for a complete list of warnings and precautions.
Like prescription medications, we believe the decision to try Cala Trio, a novel technology, first-in-class therapy, should be made between a patient and physician.
The following are possible minor/moderate risks or adverse reactions that you may experience with the use of Cala Trio:
- Discomfort with stimulation (e.g. stinging, sensation of weakness, etc.)
- Allergic reaction to electrodes or other materials
- Skin irritation, including electrical stimulation burns, redness and/or itching
In the unlikely event that any of the following more significant issues happen, immediately stop using Cala Trio and contact your physician.
- Signs of significant and persistent skin irritation, sores, electrical stimulation burns, or lesions at the site of stimulation
- Significant and persistent increase in muscle tightness or stiffness
- A feeling of chest pressure during stimulation
- Swelling of your arm, wrist, or hand
For a full list of possible side effects, please see Adverse Reactions in the Patient Guide.
Getting Started with Cala Trio
Like prescription medications, the decision to try Cala Trio, a novel technology, first-in-class therapy, should be made between a patient and physician. Whether that is your primary care physician or your neurologist that’s up to you.
We have a doctor discussion guide available on calatrio.com designed to assist your conversation with your doctor about incorporating Cala Trio therapy into your treatment plan. It provides information about essential tremor, Cala Trio, and the Cala Trio prescription form.
If you need to measure your own wrist, a flexible measuring tape works. Simply wrap it around your wrist and note the cm mark where the tape meets the beginning of the measuring tape.
Alternatively, a rigid ruler can be used. Place a piece of string or yarn around your wrist, then measure the string piece with the ruler.
If your essential tremor makes this challenging, ask a family or friend.
If you prefer, call Customer Success and we can send you a wrist measuring tool in the mail.
The long side of the prescription form has a ruler with centimeter markings. Size Reference: Small = 13.6-16.4 cm / Medium = 16.5-18.4 cm / Large = 18.5-20.4 cm.
Therapy can be administered at any time during your day.
A stimulation session is 40 minutes. Begin therapy approximately 40 minutes before any activity when you desire temporary reduction of your tremor.
During your 40-minute therapy session, most activities are fine to continue. Correct placement of the Cala Trio Band electrodes is essential to therapy success, so refrain from any activity that would cause the placement of the band to change.
Most activities are fine to do while using Cala Trio. Do not use Cala Trio while sleeping, driving, bathing, operating machinery, and doing any activity in which possible involuntary muscle contractions due to therapy may cause undue risk of injury. Please refer to the labeling for a complete list of warnings, precautions, and contraindications.
Correct placement of the Cala Trio band is essential to therapy success, so refrain from any activity that would cause the placement of the band to change. If for any reason, you need to remove the band during stimulation, stop the therapy session by pressing and holding the MAIN button until you see “therapy stopped”.
Dampen the entire circumference of your wrist with ample amounts of water before using Cala Trio. If there is any excess oil or lotion on your wrist, wash with soap and water and rinse well before wearing Cala Trio.
Water helps with the connection between your skin and the electrodes in the band. Without water you may experience discomfort or a warning display during therapy.
During set up, Cala Trio 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.
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.
Many patients in clinical studies we have conducted have continued to take medication for their tremor while using Cala Trio.
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.
The TSA changes procedures from time to time, so you could check on their website. “Remove personal electronic devices larger than a cell phone from your carry-on bag and place them into a bin with nothing placed on or under them for X-ray screening. (E.g. laptops, tablets, e-readers and handheld game consoles.)”
Additionally, some people traveling with medical devices have found it helpful to have 1) a completed TSA notification card and 2) proof of your prescription therapy to present to a TSA officer to help with passenger screening.
Cala Trio therapy is available by prescription for an individual. There are three aspects of the prescription that are unique to you. During calibration, Cala Trio learns about your tremor and personalizes therapy according to its characteristics. If a friend is interested in Cala Trio, share your experience, and encourage your friend to talk to their physician about Cala Trio.
Cala Trio can be available upon submission of a prescription by your Veterans Health Administration (VHA) health care provider. Ask the VHA to consider Cala Trio for you with these two steps:
We are here to support you!
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 calatrio.com. In the Patient Guide, review the Troubleshooting section to see details on how to address specific warning messages. On calatrio.com, you can find videos on Getting Started to lead you through setup and on Using Cala Trio to guide you through daily use of your therapy.
Should you need further help, contact Cala Trio Customer Success at 888-699-1009 and Customer Success@CalaTrio.com. We are available from Monday to Friday, 7am-4pm Pacific Time.
Cala Trio Customer Success provides support, direct to you! We will contact you when your device ships to see if you would like assistance with set up and calibration. Additionally, we provide a variety of print materials from patient guides to quick start guides as well as online resources from videos to frequently asked questions to help you with any aspect of Cala Trio therapy. Also, feel free to contact Cala Trio Customer Success via email at CustomerSuccess@CalaTrio.com or call 888-699-1009 Monday to Friday, 7am to 4pm Pacific if you have any questions.
Pricing and Reimbursement
All payment options for Cala Trio therapy come with our 60-Day Evaluation Program. You can start using Cala Trio to see how personalized, on-demand therapy reduces your hand tremor. If you are not completely satisfied, simply return it within 60 days and we will refund your purchase price minus a $99 fee. Shipping is free.
It depends. We offer different payment options to accommodate patients’ financial situations. You can purchase the stimulator outright or you can spread payments over 12 months on a payment plan. All payment plans require a valid credit card on file in a secure payment system.
To see if you qualify for our special financing option please give our Customer Success team a call at (888) 699-1009 or email us at CustomerSuccess@CalaTrio.com
Cala Trio band uses a proprietary skin interface, improving the experience of other sticky hydrogel electrodes. The band can be used for months before needing to be replaced. The performance of the band deteriorates with exposure to dry skin, skins oils, and dust. After 3 months, a new band is required in order to maintain effective therapy.
Cala Trio is a novel technology, first-in-class therapy. It is not currently covered by Medicare or private insurance. Insurance coverage for Cala Trio will take at least one year. We are working hard to keep that time frame as short as possible. We offer a number of payment options to accommodate patients’ financial situations. Cala Trio is a qualified medical expense for health savings accounts (HSA/FSA).
Please call us at (888) 699-1009 to learn about financing options and special pricing for qualified patients.
Cala Trio is eligible as a qualified medical expense for health savings and flexible spending accounts. If you have an HSA or FSA, you can use pre-tax dollars to pay for it. Check with your individual plan to understand eligibility.
Cala Trio is a novel technology, first-in-class therapy. It is not currently covered by Medicare or private insurance. Insurance coverage for Cala Trio will take at least one year. We are working hard to keep that time frame as short as possible. We offer a number of payment options to accommodate patients’ financial situations. Cala Trio is a qualified medical expense for health savings accounts (HSA/FSA). Medicare will pay for medical equipment and supplies only if a supplier has a Medicare supplier number. We do not have a Medicare supplier number, therefore Medicare will not pay for any medical equipment and supplies we sell or rent to you. You will be personally and fully responsible for payment.
Please call us at (888) 699-1009 to learn about financing options and special pricing for qualified patients.
Some VA facilities are able to purchase the Cala Trio through the local prosthetics department. Ask your Veterans Administration Medical Facility to consider Cala Trio therapy for you with these two steps: 1) Provide your VA Healthcare Provider with the Doctor Discussion Guide, and 2) Ask the Prosthetics Department to email CustomerSuccess@CalaTrio.com for Ordering Information.
If you are not completely satisfied, simply return it within 60 days and we will refund your purchase price minus a $99 Evaluation Program fee. Shipping is free.
Cala Health has your payment information for the band subscription. Every three months, you will receive a 3-month band supply. Cala will send you an email letting you know when to expect the charge and shipment. Your credit card information is stored in a secure environment and payments are compliant with the Payment Card Industry Data Security Standards (PCI_DSS).