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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wristband called Cala TWO that sends small electrical pulses to the wrist to help reduce hand tremors. It targets adults with severe essential tremor. The device works by calming the nerves in the wrist, which can lessen the shaking in the hands.

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.

Is transcutaneous stimulation for essential tremor safe for humans?

The Cala system, a device worn on the wrist for essential tremor, has been cleared by the FDA, indicating it meets safety standards for use in humans. ^{1 2 3 4 5}

How does the Cala TWO stimulator treatment for essential tremor differ from other treatments?

The Cala TWO stimulator is unique because it is a non-invasive device worn on the wrist that uses transcutaneous afferent patterned stimulation (TAPS) to deliver high-frequency pulses to the median and radial nerves, providing tremor relief by targeting the peripheral nerves rather than the brain, unlike other treatments that may involve medication or invasive procedures. ^{1 6 7 8 9}

What data supports the effectiveness of the Cala TWO stimulator treatment for essential tremor?

Research shows that peripheral nerve stimulation, like the Cala TWO stimulator, can help control arm tremors in essential tremor patients by delivering high-frequency pulses to specific nerves. A study also found that similar stimulation techniques can reduce tremor severity both during and after treatment. ^{1 7 10 11 12}

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. England pubmed.ncbi.nlm.nih.gov

Rationale and Evidence for Peripheral Nerve Stimulation for Treating Essential Tremor. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Bilateral Posterior Subthalamic Area Deep Brain Stimulation for Essential Tremor: A Case Series. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Intramuscular Stimulation of Muscle Afferents Attains Prolonged Tremor Reduction in Essential Tremor Patients. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Stimulation of the motor cortex for disabling essential tremor. [2009]

6. Germany pubmed.ncbi.nlm.nih.gov

Treatment of essential tremor: a systematic review of evidence and recommendations from the Italian Movement Disorders Association. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Transitioning from Unilateral to Bilateral Upper Limb Tremor Therapy for Parkinson's Disease and Essential Tremor Using Botulinum Toxin: Case Series. [2019]

8. England pubmed.ncbi.nlm.nih.gov

T-type calcium channel antagonists suppress tremor in two mouse models of essential tremor. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of CX-8998, a Selective Modulator of the T-Type Calcium Channel in Inadequately Treated Moderate to Severe Essential Tremor: T-CALM Study Design and Methodology for Efficacy Endpoint and Digital Biomarker Selection. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Cortical excitability in patients with essential tremor. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Resetting of essential tremor and postural tremor in Parkinson's disease with transcranial magnetic stimulation. [2005]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Afferent Patterned Stimulation Therapy Reduces Hand Tremor for One Hour in Essential Tremor Patients. [2020]