Patient FAQs

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.)

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.

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”.

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.)

Treatment for both hands is available with two (2) complete prescriptions from your physician.

Consult with your physician and determine the hand where tremor reduction would help you the most. Cala Trio provides transient relief of hand tremors in the treated hand.

Cala Trio has specific bands for left and right wrists. With two (2) complete prescriptions from your physician, we can support you in using therapy on both hands.

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.

You will feel a tingling or pulsing sensation in your fingers. You will be able to decrease the intensity during a therapy session should you feel discomfort.

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.

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.

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.

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.

Cala Trio cannot be used if you have a pacemaker.

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.

Cala Trio is splash proof, but not waterproof; you cannot swim or shower with it on.

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.

You can travel with Cala Trio. 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.

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.

At this time Cala Trio is only cleared for sale and available in the USA.

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 is now available in the greater metro areas of Austin, Seattle, Minneapolis/St. Paul, San Francisco and San Diego. VA physicians can prescribe Cala Trio. Cala Trio will be available in more markets soon.