Clinical Evidence

Essential Tremor

Essential tremor (ET) is one of the most common movement disorders that is well classified in its physiologic and phenotypic mechanisms.

The largest therapeutic clinical trial in ET, PROSPECT, was conducted using the Cala Trio™ device. Studies have shown that commonly prescribed medications benefit about half of patients with essential hand tremor which is similar to Cala Trio therapy. The electrical stimulation uses the same pathways as brain implants.

The FDA-cleared, wearable Cala Trio therapy avoids common side-effects and risks associated with traditional ET treatment options. PROSPECT Data

Cala TrioTM delivers significant tremor reduction in clinician-rated, patient-rated and objective accelerometer measurements.

The largest therapeutic essential tremor study ever conducted, PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy (PROSPECT)

Per-patient tremor power* reduction demonstrated in home-use therapy sessions

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* Tremor power is a calculation of amplitude and frequency. Tremor power decreases with lower amplitude motions and lower frequency motions.
Tremor reduction of 50% is comparable to first-line pharmacotherapies: propranolol and primidone, but without their side effect profile.2,3 Some patients had tremor reduction as large as 55-90%, similar to surgical outcomes, but without the risk of permanent side effects.2,4

 

2 Zesiewicz T a, Elble R, Louis ED, et al. Practice parameter: therapies for essential tremor: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2005;64:2008–2020.

3 Hedera P, Cibulčík F, Davis TL. Pharmacotherapy of Essential Tremor. J Cent Nerv Syst Dis. SAGE Publications; 2013;5:43-55.

4 Sinai A, Nassar M, Eran A, et al. Magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: a 5-year single-center experience. J Neurosurg. Epub 2019 Jul 5.:1–8.

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PROSPECT Data

 

 

Mechanism of Action

The Cala Trio has electrodes on the inside of the wrist band which deliver electrical stimulation to the median and radial nerves. This desynchronizes tremulous activity in the brain. This new approach of peripheral surface stimulation is thought to disrupt pathological tremor frequency signals in the central neural network and show meaningful reduction of tremor in the patient’s treated hand.

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Now you can treat your patients’ specific tremor patterns using advanced targeted therapy for more personalized care.

 

Variability of Essential Tremor

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.5

The clinical sub-types of essential tremor are not well understood at this time. This may explain the variance in the magnitude of response seen in patients using Cala Trio. On average, 54% of patients improved by at least 50% and 25% of patients improved by at least 70%, measured by tremor power.* Use of the device is the best way to assess if Cala Trio is effective for any individual patient.

* Tremor power is a calculation of amplitude and frequency. Tremor power decreases with lower amplitude motions and lower frequency motions.

5 Dietrich Haubenberger, M.H.Sc., M.D., and Mark Hallett, M.D., D.M.,N Engl J Med 378;19 May 10, 2018

 

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Early Research

Several multi-center clinical trials have studied the effectiveness of Cala Trio in treating essential tremor. Physician-rated and patient-rated improvements are shown below.

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6 Pahwa, et al. An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor, Neuromodulation 2019.

 

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Indication for Use

The Cala Trio therapy is prescribed by a physician and is indicated to aid in the transient relief of hand tremors in the treated hand following stimulation in adults with essential tremor. Refer to the indications for use for a complete list of warnings, precautions, and contraindications.

 

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