How should my patient expect Cala Therapy to feel?

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.

1. 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
2. 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:

1. Stop therapy until healed
2. Wash the affected area with soap and water
3. Use hydrocortisone cream 2.5% or petroleum jelly to aid healing of the affected area
4. Dress with gauze
5. 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:

1. Reduce stimulation intensity to a level lower than used previously
2. Add ample water over the entire wrist before each therapy session
3. 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