What side effects are associated with this type of intervention?

Peripheral nerve stimulation treatments for Essential Tremor, such as the Cala TWO device, generally have mild side effects. These can include sensations like tingling, lightheadedness, and mild discomfort at the site of stimulation. In studies, these side effects were infrequent and typically resolved quickly. Other neuromodulation techniques, like transcutaneous electrical nerve stimulation, have also reported minimal adverse events, primarily limited to local skin irritation or mild paresthesia.

What prior FDA approvals exist?

The Cala TWO device, which uses peripheral nerve stimulation to aid in hand tremor relief for Essential Tremor patients, represents a novel non-pharmacological approach. While the context does not specify prior FDA approvals for similar peripheral nerve stimulation devices, it does mention that the Cala TWO device offers an alternative to deep brain stimulation (DBS), a more invasive treatment option. DBS has been FDA-approved and is highly effective for tremor suppression, though it carries significant risks. The Cala TWO device's non-invasive nature and potential benefits highlight its importance in expanding treatment options for Essential Tremor.

What other types of research exist?

Promising novel alternatives to the Cala TWO device for Essential Tremor patients include: 1) Deep Brain Stimulation (DBS) of the ventral intermediate thalamic nucleus, which is highly effective for tremor suppression but carries significant risks. 2) Focused Ultrasound Thalamotomy, which is a non-invasive procedure that has shown safety and efficacy in clinical trials for medication-refractory tremor-dominant Parkinson's disease and essential tremor. 3) Gamma Knife Thalamotomy, another non-invasive option with long-term results for tremor treatment. These alternatives offer different approaches to managing essential tremor, ranging from non-invasive to minimally invasive surgical options.

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Behavioural Intervention

Transcutaneous Stimulation for Essential Tremor

N/A

Waitlist Available

Led By Kendall H Lee

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patient assessed at entry to study, twice daily over the course of 3 months, and at exit of study (3 months).

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed, potential side effects may include skin irritation at the site of stimulation (wrist), discomfort from wearing the device, or unforeseen reactions related to nerve stimulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patient assessed at entry to study, twice daily over the course of 3 months, and at exit of study (3 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patient assessed at entry to study, twice daily over the course of 3 months, and at exit of study (3 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and patient assessed at entry to study, twice daily over the course of 3 months, and at exit of study (3 months). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of Daily Activities Following Transcutaneous Stimulation

Assessment of Tremor Severity Following Transcutaneous Stimulation

Essential Tremor Assessment Following Transcutaneous Stimulation

Secondary study objectives

Daily Changes in Tremor over 3 Months of Transcutaneous Stimulation

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcutaneous stimulationExperimental Treatment1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Essential Tremor (ET) treatments work through various mechanisms to reduce tremor severity. Peripheral nerve stimulation, like the Cala TWO device, modulates tremor by stimulating nerves in the wrist, which can help reduce hand tremors non-invasively. Pharmacologic treatments, such as propranolol and primidone, act on the central nervous system to dampen tremor signals. Botulinum toxin injections target specific muscles to reduce tremor by temporarily paralyzing them. Deep brain stimulation (DBS) involves implanting electrodes in the brain to regulate abnormal signals. These treatments are crucial for ET patients as they offer different approaches to manage symptoms, improving quality of life and functional abilities.

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Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,298 Previous Clinical Trials

3,958,425 Total Patients Enrolled

7 Trials studying Essential Tremor

211 Patients Enrolled for Essential Tremor

Cala Health, Inc.Industry Sponsor

8 Previous Clinical Trials

838 Total Patients Enrolled

5 Trials studying Essential Tremor

738 Patients Enrolled for Essential Tremor

Kendall H LeePrincipal InvestigatorMayo Clinic

Media Library

Cala TWO stimulator (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03778060 — N/A

Cala TWO stimulator (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03778060 — N/A

Essential Tremor Research Study Groups: Transcutaneous stimulation

Essential Tremor Clinical Trial 2023: Cala TWO stimulator Highlights & Side Effects. Trial Name: NCT03778060 — N/A

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