Transcutaneous Stimulation for Essential Tremor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Ethanol dependence, Implanted device, Epilepsy, Neurodegenerative disease, Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

Adults eligible for deep brain stimulation (DBS) surgery at Mayo Clinic to treat essential tremor

Stable dose of tremor medications, if applicable, for 30 days prior to study entry

You are able to understand the study and agree to participate by signing a form.

Exclusion Criteria

You have nerve problems in your arms that could affect the test.

You have any skin problems, like infections or open wounds, on the wrist where the stimulation will be done.

You are suspected of having a specific type of Parkinson's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline function and tremor severity are collected, and subjects are fitted with the Cala TWO device

1 day

1 visit (in-person)

Treatment

Participants receive twice daily treatment with the Cala TWO device for 3 months

12 weeks

Daily home sessions

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

3 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

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?

Group I: Transcutaneous stimulation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Cala Health, Inc.

Industry Sponsor

Trials

9

Recruited

860+

Published Research Related to This Trial

Intramuscular electrical stimulation using a selective and adaptive timely stimulation (SATS) approach resulted in an average 32% reduction in tremor during stimulation in nine patients with Essential Tremor, demonstrating its efficacy.

The SATS method not only provided immediate tremor relief but also led to prolonged tremor reduction lasting up to 24 hours after stimulation, suggesting it could be a promising alternative treatment for Essential Tremor patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intramuscular Stimulation of Muscle Afferents Attains Prolonged Tremor Reduction in Essential Tremor Patients. Pascual-Valdunciel, A., Gonzalez-Sanchez, M., Muceli, S., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10588491/

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.pdf

Cala 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.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37869579/

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-tremor

Transcutaneous Afferent Patterned Stimulation Shows ... Cala Health's TAPS therapy has demonstrated effectiveness in reducing tremors for essential tremor patients, offering a promising noninvasive ...

5. tremorjournal.org tremorjournal.org/articles/10.5334/tohm.775

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 ...

6. calahealth.com calahealth.com/

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.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K243848.pdf

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.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05480215

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 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8065649/

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 ...