Cala Trio™ System
How does Cala Therapy work on my hand tremor?
Cala 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.
Will Cala Therapy reduce or eliminate my essential tremor symptoms?
Cala Therapy 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 Therapy 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 Therapy is effective for you. (Reference: Pahwa, et al. An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor, Neuromodulation 2019.)
What were the results of users who were on medications compared to users not on medications?
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.
Can I use Cala Trio therapy more than once per day? Will that result in better or longer relief?
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.
What is the battery life of Cala Trio? How long does it take to charge?
When the battery is fully charged, it will last at least 5 sessions depending on your stimulation intensity. At a low battery level, it takes 3-4 hours to fully charge Cala Trio.
How long after a 40 minute therapy session does tremor reduction last? If I use Cala Trio regularly most days, will I still benefit on the day I don’t use it?
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)
How far in advance of activity should I use Cala Trio to ensure tremor reduction later?
A stimulation session is 40 minutes. Begin therapy approximately 40 minutes before any activity when you desire temporary reduction of your tremor.
What is/are the best time(s) for me to use Cala Therapy?
Therapy can be administered at any time during your day.
What normal activities can I do while stimulating/using Cala Therapy?
During your 40-minute therapy session, most activities are fine to continue.
Do not use Cala Therapy 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 Therapy 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”.
How should I prepare my skin prior to using the Cala Trio? Can I wear lotion?
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.
What do I need to go through airport security with my Cala Trio (travel)?
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.
Is Cala Trio therapy painful? How does it feel?
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.
Does Cala Trio therapy help with hand tremor from Parkinson’s disease or multiple sclerosis?
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.
How is Cala Therapy customized to my hand tremor?
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.
What if I am not getting results from Cala 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.calahealth.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.
How do you clean Cala Trio, is it waterproof?
Cala Trio is splash proof, but not waterproof; you cannot swim or shower with it on.
Cleaning Cala Trio band can help maintain a good connection between the band and your skin. To clean the band, use a disinfecting wipe on the inside of the band to wipe the three square, black electrodes. All other Cala Trio components can also be cleaned by using a disinfecting wipe as often as once per week.