Health Care Professional FAQs
Therapy with Cala TrioTM
In our clinical study of Cala Trio therapy (see the Health Care Professional Guide for details), participants who experienced relief from therapy observed this after the 40-minute stimulation session. We recommend using Cala Trio twice per day for two weeks to evaluate if and how therapy works for you. Note that it is designed to provide at least five sessions when fully charged.
Yes, Cala Trio is designed to stimulate nerves in the left OR right wrist. The device is not interchangeable between the left and right hand. Cala Trio provides transient tremor relief in the treated hand.
The clinical trials evaluated Cala Trio therapy in one hand only. It is unknown if use on both hands will provide better, worse, or similar benefit. 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.
The optimal stimulation level for Cala Trio therapy should be perceptible but comfortable tingling sensation in their thumb, pointer, middle, and ring fingers. Your patient may notice that as they move their hand around the intensity and location of sensation can change. Exactly where they position the device, the amount of water they apply to their wrist before putting the device on, and the stimulation level can affect the way they feel the stimulation sensation. The sensation should be strong, but they should be comfortable going about their daily life for the 40-minute stimulation session.
The 40-minute stimulation duration was informed by research leading to the clinical study supporting Cala Trio labeling.
Calibration is important to ensure an effective therapy. During a stimulation session, the device sends patterned stimulation to the median and radial nerves based on the patients’ tremor frequency. Tremor frequency is determined by measuring 3 postural holds performed during setup. Tremor frequency in patients with essential tremor is typically 4-12 Hz. If the patient is not receiving benefit from therapy, the device can be recalibrated. You can find instructions for recalibration in the Health Care Professional Guide.
See the section on How to Recalibrate Cala Trio in the HCP Guide. In order to ensure effective therapy, or if the device is calibrated incorrectly Cala Trio may need to be recalibrated after initial setup.
From the time screen, press the UP and DOWN buttons simultaneously for three seconds to enter the Calibration Menu.
Instruct the patient to perform their prescribed “Tremor Task” and press the MAIN button to start the calibration. Have the patient continue their “Tremor Task” until all dots are blue (20 secs). The device will vibrate to indicate when the “Tremor Task” is complete.
After calibration, press MAIN to save. If you do not want to save the calibration, press DOWN and then MAIN to exit.
Cala Trio band uses a proprietary skin interface, improving the experience of 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. Over the course of months, the band is eventually unable to support effective therapy. Cala Trio informs the user five days before a band needs to be replaced. Cala Health automatically supplies Cala Trio patients with a 3-month band supply to maintain effective therapy.
Yes; the performance of the band deteriorates with exposure to dry skin, skins oils, and dust. Over the course of months, the band is eventually unable to support effective therapy. Cala Trio informs the user five days before a band needs to be replaced. Cala Health automatically supplies Cala Trio patients with a 3-month band supply to maintain effective therapy.
Prescribing Cala TrioTM
Cala Trio therapy is indicated to treat essential tremor.
At present, we do not know if Cala Trio can/will reduce the need for medications. Cala Health continues to study Cala Trio therapy to better understand its use and efficacy in these situations.
Participants in clinical trials used this therapy as monotherapy or in combination with standard ET medications. Medications included but were not limited to primidone, propranolol, and gabapentin. There were no reported interactions between Cala Trio therapy and medications prescribed to reduce ET symptoms. Cala Health continues to study Cala Trio therapy to better understand its use and efficacy in these situations.
Cala Trio is indicated to treat essential tremor. The clinical studies were conducted with patients that have essential tremor only. We do not yet have data for patients with other neurological conditions.
The device should NOT be used:
- by patients with an implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator.
- by patients that have suspected or diagnosed epilepsy or other seizure disorder.
- by patients who are pregnant.
- on swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions.
Refer to the labeling for a complete list of contraindications, warnings and precautions.
DBS is contraindicated because of the potential risk for interference between Trio and an implanted electrical stimulator.
Participants in the clinical study experienced mild to moderate skin irritation, including sores, electrical stimulation burns or lesions, redness and/or itching at the site of stimulation. For a full list of possible side effects, please see Adverse Reactions in the Health Care Professional Guide.
Fatigue has not been a reported as a side effect of Cala Trio therapy in clinical trials.
Consider the following for this patient:
- Stop therapy until healed
- Wash the affected area with soap and water
- Use hydrocortisone cream 2.5% or petroleum jelly to aid healing of the affected area
- Dress with gauze
- Do not use aloe vera
Once the affected area has healed, if you and the patient agree to continue using therapy, consider the following guidance:
- Reduce stimulation intensity to a level lower than used previously
- Add ample water over the entire wrist before each therapy session
- Tighten and position the band so that the electrodes are flush to the skin; this may include positioning the band higher or lower on the wrist so that the electrodes contact flatter or less curved areas of the wrist.
Download the prescription form online. Simple instructions are provided. Fax the prescription to 833-230-9251.
Sizing the device is easy.
- Choose which hand to treat. Cala Trio is designed to stimulate nerves in the left OR right wrist. The device is NOT interchangeable between the left and right hand.
- Measure the patient’s wrist circumference over the wrist bone (head of the ulna/styloid process) to determine band size. Measurement guides are available to download at www.calatrio.com. Small is 13.6 – 16.4cm. Medium is 16.5 – 18.4cm. Large is 18.5 – 20.4cm.
- After fitting the device, the physician should choose a tremor task, either wing-beating or outstretched postural hold, for calibration and tremor measurements. The “Tremor Task” is a postural hold that is repeated to characterize the patient’s tremor. CHOOSE the MORE SEVERE postural hold.
Setting up Cala Trio includes
- Positioning and Fastening Cala Trio
- Calibrating Cala Trio
- Setting Therapy Intensity
See the section for Setting Up Cala Trio in the Health Care Professional Guide for details on each of these steps.
Efficacy
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; *note- meaningful symptomatic improvement is greater than 30% tremor reduction. 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.)
The short-term tremor reduction can last for up to an hour and a half after a single session. However, there is a large variation in the length of time tremor relief lasted. Cala Health is working to understand the factors that affect this variation in benefit duration. (Reference: Data on-file, publication pending)
A randomized clinical trial1 with 77 patients with essential tremor was conducted. 40 participants received Cala Trio therapy and 37 participants received a sham device. Results were rated by physicians (TETRAS) and patients (ADLs) after a single 40-minute session.
- 75% of subjects displayed temporary meaningful tremor symptom improvement in TETRAS as rated by blinded expert physicians (greater than 30% tremor reduction)
- 70% of subjects reported meaningful tremor symptom improvement in ADLs (greater than 30% tremor reduction)
In a subsequent study, patients displayed significant tremor reduction lasting for up to an hour and a half2.
1 Refer to the physician labeling for details on this study. (Pahwa, R. , Dhall, R. , Ostrem, J. , Gwinn, R. , Lyons, K. , Ro, S. , Dietiker, C. , Luthra, N. , Chidester, P. , Hamner, S. , Ross, E. and Delp, S. (2019), An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor. Neuromodulation: Technology at the Neural Interface. doi:10.1111/ner.12930)
2 Data on-file, publication pending
Mechanism of Action
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.
With Cala Trio, therapy is calibrated to the patient’s specific tremor motion by performing a tremor-inducing postural hold for 20 seconds. In order to calibrate therapy, prescribers should select the tremor-inducing task that exhibits the maximum tremor for each patient. This step is important to ensure effective therapy for each user. The accelerometer in the device measures the patient’s tremor motion, calculates the dominant tremor frequency, and stores that information to deliver patterned stimulation to the median and radial nerves.
Cala Trio is a neuromodulation device that communicates with the body. Neuromodulation devices use electrodes to deliver stimulation to nerves in the body inhibiting signals or triggering neural impulses. Two aspects make Cala Trio unique, 1) delivering patterned peripheral nerve stimulation to the median and radial nerves that send signals to the brain, and 2) surface stimulation of the skin, avoiding surgical procedures.
With Cala Trio, therapy is calibrated to each patient’s specific tremor. The sensor in the device measures the frequency of tremor. Then during therapy, the device sends patterned stimulation to the median and radial nerves at the patient’s tremor frequency.
Pricing and Reimbursement
As a novel, first-in class therapy, insurance coverage is not yet available. The process for obtaining insurance coverage for new therapies takes years. Because of the importance of insurance coverage, we have proactively planned for this work, started it, and will provide updates on our progress. In the meantime, rather than wait to offer it with insurance coverage, we are bringing this therapy to tremor patients to help control their tremor now. We offer a number of payment options to accommodate patients’ financial situations. Cala Trio therapy is eligible as a qualified medical expense for health savings and flexible spending accounts. If your patients have an HSA or FSA, they can use pre-tax dollars to pay for it. They should check with their individual plan.
Cala Health offers numerous payment plans, if desired. Payment plans start at $159/mo. Cala Trio therapy is eligible as a qualified medical expense for health savings and flexible spending accounts. If your patients have an HSA or FSA, they can use pre-tax dollars to pay for it. They should check with their individual plan.