Healthcare Professionals and Cala Trio™ therapy
Today you can offer your essential tremor patients a safe and effective non-invasive therapy without the risks of surgery or pharmaceutical side effects.
Today you can offer your essential tremor patients a safe and effective non-invasive therapy without the risks of surgery or pharmaceutical side effects.
Cala Trio therapy gives your patients control over the demands of their daily activities impacted by hand tremor.
The Cala Trio device is an FDA-cleared Class II Medical Device for the external upper limb tremor stimulator and is safe, effective, and individually calibrated to each patient's unique brain signal pattern.1,2,3
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 (neuromodulation), which targets the root cause of the hand tremor.
Clinical Evidence
What is the PROSPECT study?
PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy. Cala sponsored the largest non-invasive therapeutic clinical research study ever conducted at 26 clinical sites, 231 patients were enrolled in a 3-month study.
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. (Reported by patients using Bain-Finley Activities of Daily Living (BF-ADL).1
62% of patients improved from “Severe” or “Moderate” tremor at the beginning of the study to “Mild” or “Slight” tremor. (As measured by physicians using TETRAS.)1
64% of patients reported having persistent relief for an average of 94 minutes (standard deviation = 138; median = 60).1
Real World Clinical Evidence
A retrospective post-market surveillance study evaluated the real-world effectiveness of Cala Trio therapy based on a total 321 users. This data further confirms efficacy findings from PROSPECT and provides insight into long-term usage of peripheral neuromodulation.4Patient Access
Cala is committed to ensuring all patients have access to Cala Trio therapy. Our Cala Customer Care specialists offer the following assistance to facilitate patient access to therapy:
- Verification of patient insurance benefits.
- Work with you to collect medical necessity documentation.
- Process prior authorization requests (as needed)
If you and the patient determine that Cala Trio therapy is not right for them, they notify Cala and send the device back before the end of the 60-day return period. If this happens, the patient is not held responsible for any costs.*
*Patient agreement is required; Medicare patients are not eligible to participate.
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Mechanism of Action — Essential Tremor Relief with Peripheral Non-invasive Neuromodulation
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Learn more about
Cala Trio therapy
For the visually impaired, a full text alternative of this video is available here
| AUDIO / VO | VISUALS | NOTES | |
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1 |
Music Over |
Opening bumper Cala Trio logo and tag |
"Hands" opening sequence - Last shot of animation locks to first shot of incoming scene. |
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VO: "Essential tremor is a benign yet life-altering condition that impairs performing day to day activities. Although onset typically occurs of essential tremor typically occurs in adults 50 and older, symptoms may appear much earlier in life. Music under |
Title – Understanding Cala Trio. A breakthrough individualized therapy for essential tremor Shots of (2) tremor patients trying to do tasks untreated – frustrated. Nothing is easy. |
Condensed Intro from Product Hero Video including shots of tremor patients trying to do tasks untreated that follows VO. |
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3 |
VO: "A majority of essential tremor patients exhibit postural and kinetic tremor in the upper limbs. In some cases, patients may exhibit tremor of the head, face, voice, trunk or lower limbs." |
MCU patient hands w/ tremor OR a Grey's anatomy showing where on the body tremor can affect |
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4 |
VO: "The exact pathogenesis of essential tremor is unknown. It may be a result of a complex neural involving multiple structures in the cerebellum, basal ganglia, and cortex. Deep brain structures, such as the ventral intermediate nucleus—or VIM—of the thalamus, are also considered relay points in this network." Music under |
Animation – Follow VO Stylized animation showing the VIM region in the Brain Close-up's or call-outs for details on specific areas and functions highlighting the relay points to the neural network Details, text call-outs, and other supporting GFX to follow VO |
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5 |
VO: "Evidence has shown that Invasive brain surgery that targets the VIM, including deep brain stimulation and thalamotomy procedures has been effective in treating essential tremor symptoms. But for most physicians and patients a less invasive and lower risk option has always been desired" |
Show images of scientific journal quotations that support the efficacy of invasive stim – news headline style? |
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6 |
VO: "Now from Cala Health, A breakthrough treatment of essential tremor is here. Introducing Cala Trio, a non-invasive option specifically designed to target the tremor network with peripheral nerve stimulation through the wrist. Surface stimulation is delivered to the median and radial nerves disrupting the pathological tremor frequency signals. This effectively addresses the variability of your patients condition resulting in a meaningful reduction of the tremor a period of time" Music under |
Live action to animation (composite) Patient at home in background… Trio sits on table in foreground. Patient walks up (into focus) and puts it on… Sits... CU - Show pressing start button and lines simulating stimulation up the arm in bursting pattern MED - Show stimulation (2 lines traveling up the arm to the brain). Show region of the nerve location on the wrist shaded and brain (suggesting target zone). Action, pacing and GFX support follow VO |
Shoot 4k – zoom in to focus on details |
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7 |
VO: "Cala Trio provides on-demand tremor relief after a 40 minute stimulation session. In a controlled clinical trial, 62% of patients experienced meaningful symptom improvement using Cala Trio therapy at home. 68% of users reported improvement in activities of daily living. Most notably in handwriting, holding a cup, and using a spoon. Users that experienced benefit reported tremor relief lasting up to an hour and a half following therapy. The most common reported side effect in the study was mild to moderate skin irritation, including electrical stimulation burns, redness and/or itching" |
Info – graphics over outgoing scene Video of 1 pre & post postural task from TETRAS comparison segment. (Condensed; don't show data on left) Then Graphically show 3 semi-circles of the key statistics the VO is stating (75%, 78%, 48%) with "TETRAS rating by blinded physicians" Text on screen bottom A 3% mild adverse event rate across treatment and sham groups included skin irritation. This resolved within 24 hours without treatment or sequalae. |
May also have publication credit across the bottom of the screen as required |
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8 |
VO: "Essential tremor is a progressive and clinically heterogeneous condition with sporadic and familial forms. Tremor amplitude increases with age. Accounting for substantial disability in older people. Understandably the magnitude of response varies in patients using Cala Trio." |
Animation Show oscillations graphically from accelerometer at the bottom of the screen while a patient does a postural hold |
Cala clinical science team is working on how we want to show this and describe the variable response |
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VO: "on average a 49% reduction in tremor amplitude is demonstrated. However some patients have greater than an 80% reduction. Use of the device is the best way to asses if Cala Trio is effective for any individual patient. With Cala Trio, therapy is calibrated to the patient's specific tremor motion by performing tremor tasks for 20-second.This only needs to be performed the first time the device is used. The accelerometer inside Cala Trio will measure the frequency of the patient tremor across 3 axes. During therapy, patterned stimulation to the median and radial nerves is delivered at the patient's tremor frequency." Music under |
Outstretched hands in postural hold with device on; patient is doing this alone in a home environment CU show ‘measurement stored' screen. Then show patient starting therapy and the animation of the stimulation traveling up the arm in 2 lines or 2 waves small text on screen: Cala Trio can be recalibrated as needed. |
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10 |
VO: "Traditionally, stimulation products used on skin use hydrogel electrodes that can only be applied once and leave a sticky residue." A proprietary electrode has been created for Cala Trio. This allows multi-day wear of the electrodes. The Cala Trio band can be used for 90 days which improves the user experience of traditional hydrogel electrodes. "The device monitors days of use and will remind the patient to change their band." |
Visual: a picture of traditional sticky hydrogels being peeled off the skin Close up of electrode on Cala Trio Band with live action of the patient putting on the device Or image of the electrodes close-up and then live action to the device on a patient's wrist CU "replace band" screen Text on screen sync'ed with VO saying one month: Bands are worn for 1 month |
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VO: "The device has a battery that provides at least 5 stimulation sessions between charging. The base station is magnetized making it easy for users with essential tremor to secure it into place. Cala Trio should be stored in the base station when not being worn." |
Visual of charging base on a table with cord plugged into the wall The stimulator attached to a band being slid down into charging opening. (slow mo or graphics to represent magnetic effect??) CU charging screen of the device |
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"Cala Trio requires a physician's prescription. Prescription forms can be downloaded from the Cala Trio website. There are 3 important elements of the prescription First, the device is unique to the patients right or left-hand. In order to match the anatomical nerve locations in the wrist. Second, various sizes are available to ensure proper fit. So that stimulation is delivered to the target nerves Lastly, prescribers select the tremor-inducing task which elicits the maximum tremor. This information ensures the calibration step is optimized." |
Live action MD prescribing the device for a patient in a clinic setting Show the prescription form Photo of left and right-handed devices placed on two wrists correctly - overlay reinforcing the large button is towards the elbow Text on screen to match VO: 3 elements of the prescription
Prescription forms available at http://www.calatrio.com/HCP Cala Trio Therapy is a contraindicated for patients with cardiac pacemaker, implanted defibrillator, or other implanted electronic device, or implanted metal in the wrist. |
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13 |
VO: "once the prescription is processed, the cala trio is shipped directly to your patients home with complete instructions. Prescribers may opt to have the device shipped to their office for therapy initiation./p> The Cala Health Customer Success team is available to answer all of your patients questions" |
Live action - Patient receives package Show patient opening a door at home and being handed their Cala Trio package, then sitting at a desk setting it up Patient on phone visual if time allows |
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14 |
VO: "A breakthrough in care is here. Specifically designed for your patients with essential tremor. Providing on demand and individualized treatment. Cala Trio allows patients to activate their therapy, when and where they need it, without systemic side effects or drug interactions. Inspire more present moments, welcome more meaningful engagements, and deliver better outcomes to your essential tremor patients with Cala Trio therapy." |
Collage of live action shots of patients living their fullest life wearing Cala Therapy |
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15 |
Music under Sting or Fade Out |
Close with Cala Trio logo and the tagline "Freedom to Be" Bottom Disclaimer: Caution: 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 warnings, precautions, and contraindications. Engineered by Cala Health www.calatrio.com 1-888-699-1009 |
FDA Cleared
Read the Clinical Research to learn more about how Cala Trio can help patients with essential tremor.
The Cala Trio device is cleared by the FDA as an external upper limb tremor stimulator, Class II (initially under de novo DEN170028 with subsequent 510(k) clearances K182706 and K203288).
Healthcare Provider Steps for Prescribing:
Review indications for use and contraindications
Indications for Use: To aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor (ET)
Please supply medical necessity documents with the prescription to ensure the most efficient insurance approval process. This saves your office staff time. The Cala Customer Care team can help the patient understand the copayment amount determined by their specific benefit plan.
Prescription (interactive PDF), Medical Necessity,Patient Intake, and Agreement forms
Choose which hand to treat* and select the “tremor task” — a postural hold** that is used to characterize the patient’s tremor and calibrate the therapy.
*Each Cala Trio device is designed for the left OR right wrist. The device is not interchangeable.
**Assess both tasks and choose the more severe postural hold.
Accurate measurement of the patient’s wrist is essential to safety and efficacy.
Example of wrist placement
What happens when a prescription is received
- Cala Customer Care team contacts the patient to confirm insurance details from the Patient Intake and Agreement form and provides an estimate of copayment, prior authorization (if needed), and coverage.
- Upon receipt of prior authorization (if needed), the patient signs the agreement form (if not previously submitted), and Cala Therapy is shipped to their home.
- Once the Cala Trio device is delivered, a 30-minute training session is available.
- If you and the patient determine that Cala Trio therapy is not right for them, they notify Cala and send the device back before the end of the 60-day return period. If this happens, the patient is not held responsible for any costs.*
*Patient agreement is required; patients using Medicare benefits are not eligible.
Cala gives your essential tremor patients Freedom to be.™
What happens when a prescription is received
- Cala Customer Care team contacts the patient to confirm insurance details from the Patient Intake and Agreement form and provides an estimate of copayment, prior authorization (if needed), and coverage.
- Upon receipt of prior authorization (if needed), the patient signs the agreement form (if not previously submitted), and Cala Therapy is shipped to their home.
- Once the Cala Trio device is delivered, a 30-minute training session is available.
- If you and the patient determine that Cala Trio therapy is not right for them, they notify Cala and send the device back before the end of the 60-day return period. If this happens, the patient is not held responsible for any costs.*
*Patient agreement is required; patients using Medicare benefits are not eligible.
Cala gives your essential tremor patients Freedom to be.™
Cala is an ACHC accredited Durable Medical Equipment Provider
Cala Customer Care supports your patient with training, home delivery, and technical support like a specialty pharmacy. Cala maintains accreditation through the Accreditation Commission for Health Care (ACHC), a non-profit healthcare accreditation organization focused on the needs of small providers.Yes; the performance of the band deteriorates with exposure to dry skin, skin oils, and dust. Over the course of months, the band is eventually unable to support effective therapy. Cala Trio informs the user ten (10) days before a band needs to be replaced. Cala Health automatically supplies Cala Trio patients with one band every three months to maintain effective therapy.
MKG-1050 Rev P Aug 2021
It is recommended that other devices be used in separate sessions since no data has been published using electrical stimulation devices simultaneously with Cala Trio.
Cala Therapy 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 Therapy informs the user five days before a band needs to be replaced. Cala Health automatically supplies Cala Therapy patients with one band every 3 months to maintain effective therapy.
Does the band need to be replaced even if the patient isn’t stimulating every day?
Yes; the performance of the band deteriorates with exposure to dry skin, skin oils, and dust. Over the course of months, the band is eventually unable to support effective therapy.
MKG-1050 Rev P Aug 2021
The optimal stimulation level for Cala 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.
What are the side effects?
Patients using Cala Therapy have experienced two main side effects.
- Mild to moderate skin irritation, including sores, electrical stimulation burns or lesions, redness and/or itching at the site of stimulation: 11% in the PROSPECT trial
- Significant discomfort, electrical shock sensation, and pain: 4% in the PROSPECT trial
Of the 18% of patients who experienced a device-related adverse event, none of these were considered serious (see Table 4 in the PROSPECT publication).
For a full list of possible side effects, please see Adverse Reactions in the Health Care Professional Guide.
What guidance can I consider for my patient who has experienced skin irritation, including electrical stimulation burns, redness and/or itching from using Cala Trio therapy?
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.
MKG-1050 Rev P Aug 2021
- 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.
- 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.
- The Cala Trio device is cleared by the FDA as an external upper limb tremor stimulator, Class II (initially under de novo DEN170028 with subsequent 510(k) clearances 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
