Cala Therapy 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 Therapy unique:
1) delivering patterned peripheral nerve stimulation to the median and radial nerves that send signals to the brain
2) surface stimulation of the skin, avoiding surgical procedures. Cala 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.
How is Cala Therapy calibrated to the patient’s individual tremor?
Cala Therapy is calibrated to the patient’s specific tremor motion by performing a tremor-inducing postural hold for 20 seconds. Tremor frequency is determined by measuring 3 postural holds, either Outstretched and Wing-beating postural holds, performed during setup. In order to calibrate therapy, prescribers should select the tremor-inducing task that exhibits the maximum tremor for each patient. 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. During a stimulation session, the device sends this patterned stimulation to the median and radial nerves based on the patients’ tremor frequency. Tremor frequency in patients with essential tremor is typically 4-12 Hz.
What can clinicians and users control about Cala Therapy stimulation to optimize therapy?
Clinicians and users do not need to adjust stimulation to optimize therapy. Cala Therapy is set up to be optimized to the frequency of your patient’s hand tremor. This frequency is automatically determined during setup in a series of Tremor Tasks a prescriber assigns a patient.
Clinicians and users can control two things:
1) comfort of the stimulation
2) proper use of the therapy
To control the comfort of stimulation, patients can adjust the intensity of Cala Therapy to a level that supports paresthesia and is comfortable while doing light activities. If it starts to feel uncomfortable when moving arm, wrist, hand, and fingers, they can decrease it. To support the proper use of the therapy, a clinician can guide a patient in two ways. First, help confirm the patient feels paresthesia in some part of their hand, palm, and fingers from their middle finger to their thumb. Second, help guide the patient to adjust the stimulation intensity to a level that is comfortable for them while doing light activities like eating and drinking.
Is Cala Therapy effective in severe patients?
In the PROSPECT study on-at-home use of Cala Therapy, 62% of patients with ‘severe’ or ‘moderate’ hand tremor improved to ‘mild’ or ‘slight’ as defined by TETRAS, a clinician-rated Tremor Research Group Essential Tremor Rating
Assessment Scale. <more> Additionally, real-world evidence of therapy has shown that 93% of patients had a ≥2-fold improvement (i.e., 50% reduction) in tremor power during their most severe sessions (i.e., when tremor relief was most needed). <more>
MKG-1050 Rev P Aug 2021