Transcutaneous Stimulation for Essential Tremor
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new wristband device, Cala TWO, which may help reduce hand tremors in people with essential tremor, a common condition causing involuntary shaking. The study aims to determine if using this device twice daily for three months can effectively manage tremors without the risks of brain surgery. The trial seeks adults already approved for deep brain stimulation surgery at Mayo Clinic. Participants will wear the Cala TWO device to assess its effectiveness in providing tremor relief. An optional part of the study includes brain scans to examine any changes in brain activity. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new non-surgical treatment options for essential tremor.
Will I have to stop taking my current medications?
The trial requires that you stay on a stable dose of your current tremor and antidepressant medications during the study. You don't need to stop taking them, but you must not change the dosage.
What prior data suggests that the Cala TWO device is safe for essential tremor patients?
Research shows that the Cala TWO stimulator is generally safe for people with essential tremor. Studies have found that similar devices, like the Cala Trio, are well-tolerated by users. These devices help reduce hand tremors by stimulating nerves in the body. The FDA has approved the Cala Trio, confirming it meets safety standards for treating tremors.
Previous research on this type of therapy, called TAPS (transcutaneous afferent patterned stimulation), indicates it is safe for many people with essential tremor. No major reports of severe side effects have emerged, suggesting these devices are a safer option compared to more invasive treatments like deep brain stimulation.
Overall, the evidence supports the safety of the Cala TWO device, making it a promising choice for those seeking relief from tremors without significant risks.12345Why are researchers excited about this trial?
Unlike standard treatments for essential tremor, which often involve medications like beta-blockers or anti-seizure drugs, the Cala TWO stimulator offers a non-invasive option by using transcutaneous stimulation. This device targets specific nerves in the wrist to reduce hand tremors, providing a unique mechanism of action compared to traditional oral medications or invasive surgical options like deep brain stimulation. Researchers are excited about the potential of Cala TWO because it offers a wearable, drug-free alternative that could significantly improve quality of life without the side effects associated with current treatments.
What evidence suggests that the Cala TWO device is effective for essential tremor?
Research has shown that the Cala TWO device, which uses a special type of nerve stimulation, may help treat essential tremor. In one study, 45% of patients using this therapy experienced a reduction in their tremors by at least half. Another study found that combining this therapy with regular treatment led to better results than regular treatment alone. Long-term data indicated that 89% of patients noticed some improvement in their tremors, with an average improvement of 64%. These findings suggest that the Cala TWO device, which participants in this trial will use, could be an effective, non-invasive option for reducing hand tremors in people with essential tremor.26789
Who Is on the Research Team?
Kendall H Lee
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Adults over 21 years old with essential tremor approved for deep brain stimulation surgery at Mayo Clinic can join. They must have been on a stable dose of tremor and antidepressant medications, if taken, for specific periods before the study starts. Participants should not consume significant alcohol or caffeine or use the Cala TWO device within 8 hours of study visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline function and tremor severity are collected, and subjects are fitted with the Cala TWO device
Treatment
Participants receive twice daily treatment with the Cala TWO device for 3 months
Optional PET/CT Assessment
Optional PET/CT sessions to evaluate changes in brain metabolism at baseline, after acute stimulation, and at the end of 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cala TWO stimulator
Trial Overview
The trial is testing the Cala TWO wristband device as a non-invasive treatment to reduce hand tremors in essential tremor patients. It involves twice-daily treatments over three months and optional PET/CT scans to monitor brain activity changes due to the therapy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants in the clinical study will consist of subjects with essential tremor who are scheduled more than 3 months in advance to undergo deep brain stimulation surgery for treatment of essential tremor at Mayo Clinic. Subjects will wear a Cala TWO stimulator to reduce hand tremors.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Cala Health, Inc.
Industry Sponsor
Published Research Related to This Trial
Citations
A Randomized Pragmatic Clinical Trial - PMC
TAPS therapy used over one month resulted in 45% of patients experiencing a ≥50% tremor power reduction (≥2 improvement ratio in tremor power, ...
2.
calahealth.com
calahealth.com/wp-content/uploads/2024/01/SD-20014-Clinical-Press-Release-JAN-2024.pdfCala Announces Data from Multiple Clinical Studies ...
A randomized pragmatic trial by CVS Health found that adding Cala TAPS therapy to standard of care (SOC) improved outcomes over SOC alone.
A Randomized Pragmatic Clinical Trial
This study found that adding TAPS treatment to SOC significantly improves tremor power and BF-ADL scores in patients with ET compared to SOC ...
4.
neurologylive.com
neurologylive.com/view/transcutaneous-afferent-patterned-stimulation-shows-effective-outcomes-essential-tremorTranscutaneous Afferent Patterned Stimulation Shows ...
Cala Health's TAPS therapy has demonstrated effectiveness in reducing tremors for essential tremor patients, offering a promising noninvasive ...
Real-World Evidence with Long Term Follow-Up
Accelerometry data indicated 89% of patients experienced tremor improvement, with an average 64% improvement. 63% of patients rated at least ...
Cala kIQ - Cala kIQ
The only FDA-cleared, wearable device that delivers effective therapy for action hand tremor in people with essential tremor and Parkinson's disease.
January 16, 2025 Cala Health, Inc. Amanda Johnston ...
Cala kIQ is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
Symptomatic Relief of Action Tremor With Cala Trio Using ...
Demonstrate safety and effectiveness of symptomatic action tremor relief in the treated hand following stimulation with the Cala Trio System ...
Medical Devices for Tremor Suppression: Current Status and ...
The newer version of this device, Cala Trio (Cala Health, USA; previously known as Cala TWO), is currently FDA-registered. The PROspective study for SymPtomatic ...
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