Daily Use of Cala Trio Device Effectively Eases Hand Tremors, Trial Reports

Daily Use of Cala Trio Device Effectively Eases Hand Tremors, Trial Reports

Using Cala Health’s non-invasive therapeutic device Cala Trio for 40 minutes twice daily effectively helped to reduce hand tremors within three months, results from a clinical study show.

The results, “Study Design, Baseline Demographics, and Interim Results from the Prospective Study for Symptomatic Relief of Essential Tremor with Cala Therapy (PROSPECT) Trial” (LBA No. 9), were presented at the International Congress of Parkinson’s Disease and Movement Disorders in Nice, France.   

Cala Trio is a wrist-worn device that delivers neuromodulation therapy, calibrated to individual needs, through the skin to provide symptomatic relief of hand tremors. The device gently stimulates the nerves responsible for the tremor, interrupting nerve circuits to allow for better control of movement.

“We are thrilled with the results of the PROSPECT trial. It is tremendously exciting to see the relief our non-invasive neuromodulation therapy brings to patients with essential tremor, without surgery or drugs,” Kate Rosenbluth, founder and chief scientific officer at Cala Health, said in a news release. “We are deeply grateful to the patients and investigators who participated in this study.”

The PROSPECT trial (NCT03597100) claims to be largest study conducted in patients with essential tremor, a benign neurological condition that is characterized by uncontrolled, rhythmic shaking, typically in the limbs. The trial enrolled 263 people at 26 U.S. sites; all had essential tremor symptoms for an average of more than 25 years (median age at study, 69.6).

Essential tremor — often misdiagnosed as Parkinson’s disease — is a progressive movement disorder most common in people ages 40 and older. It mainly affects the hands and arms, but head, voice, and leg tremors are also known.

Unlike Parkinson’s, which is associated with motor symptoms such as slow movement and muscle stiffness, essential tremor does not cause other health problems, although unsteady gait may be observed. Parkinson’s patients also typically experience tremors when their hands are at rest, while essential tremor is evident when people are using their hands.

Trial data showed that, for a majority of these people, using Cala Trio in 40-minute sessions twice daily for three months effectively reduced hand tremor severity. The average symptom relief lasted 96.7 minutes after each stimulation session — done at least two hours apart — in patients reporting benefits.

In total, 62% of participants improved from severe or moderate tremors to mild or slight tremors, according to the physician-reported Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS); 68% said their tremors went from severe or moderate before treatment to mild after Cala Trio use, according to results of the self-reported Bain and Findley Activities of Daily Living (ADL) scale.

Overall, 54% of patients reported a greater than 50% reduction in tremor power after finishing the study’s three months of treatment, and 25% experienced a 70% easing in tremor power, the study reports.

Participants also reported significant improvement in Quality of Life in Essential Tremor Questionnaire (QUEST) scores by study end.

“For patients living with ET [essential tremor], this means that they can now more easily complete daily tasks such as handwriting, drinking from a glass, and using a soup spoon — tasks that were otherwise much more difficult,” said Stuart Isaacson, MD, director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton in Florida.

“Treatment with Cala Trio represents a novel approach to improving tremor in people living with essential tremor and provides a safe and effective therapeutic option.”

Transient device-related adverse events were reported in 18% of participants, which included wrist discomfort, skin irritation, and pain. None required medical intervention.

Cala Trio has been cleared by the U.S. Food and Drug Administration to treat essential tremor, and is currently available by prescription in select U.S. markets.

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Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.
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9 comments

  1. Wendy Thomas says:

    I have had ET for many years. It rules my life. I would be very pleased to be free of it! Any information you have would be gladly received.

  2. Ed Brand says:

    I’m delighted this technology may help those with ET, but the headline is misleading, as it does not seem to pertain to Parkinson’s tremor.

  3. Are you doing any more trials? I would love to be able to participate in one of the trials.

    I have had ET since I was a teenager. I always dealt with and compensated for my tremors and figured that they were the norm. ET is hereditary in father’s side of the family. Two of my siblings have ET as well as two of my children.

    About four years ago, I finally had a diagnosis by a neurologist who then tried me on Propranolol, it helped except that I have low blood pressure and they couldn’t give me a higher dosage because of my low blood pressure; Gabapentin, it didn’t do anything except started causing memory loss; Primadone, it made me extremely dizzy and nauseous and needed a walker to be able to walk and this was at 50mg taken at night.

    Also, can this be Medicare approved?

  4. Roland Dusseault says:

    I have been living with essential tremors for over 35 years.
    Propanalol has helped a bit, but I have low blood pressure, and a low heart rate, so the dosage has to be limited.
    Primidone causes me to become quite lethargic, and confused.
    I was in a study at the University of Toronto, and had focused ultrasound under mri, in order to destroy part of (I think), my thalamus. This showed some good results for about 6-8 months, but I am right back to where I was prior to the surgery(except now with a numb lower lip, and numbness in my fingertips)..side effects.
    Different strengths and dosages of cbd oil have not helped.
    Is it possible For a neurologist in Canada to obtain a Cala Trio, for a trial with his/her patients?

  5. I was briefly on this study (Cala trio) for approx. one month. I didn’t really see much improvement if any with the tremor. I was encouraged to put the setting as high as I could tolerate (1-12 I think levels). I stuck with around 5 or so. Wore it diligently twice a day for the time I was supposed to and it really didn’t help.
    btw, I am sad to hear of Roland’s experience with FUS. I thought that might have long-term benefits. I don’t know if they have done long-term studies on people who have had it done. I am not a candidate but may be eligible for DBS which frightens me. There is a device in England I want to see get developed – wrist band that helps calm hand tremors.

  6. Lindsey says:

    It would be helpful if essential tremor patients who treated with ultrasound or DBS would share their results. We hear a lot about the promotion of these procedures but little from the people who have had the treatment.

  7. Rhonda Harryman says:

    I have lived with ET for 30 years. Father and brother had this too. I see a neurologist at Mercy Neurology in OKC,OK. I would like to be notified when Medicare will cover or if I can participate in a study in the OKC area. I take propranolol 40mg 3 times daily. Helps a bit. Also think I have beginning central tremors. Thank you for not using my email for any other purpose. R.L. Harryman

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