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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 is testing a device that sends electrical signals to peripheral nerves to relieve hand tremors in people with essential tremor. The device is worn on the wrist and used twice daily. The study will last 3 months and will enroll 20 people at Mayo Clinic in Rochester, MN.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of Daily Activities Following Transcutaneous Stimulation
Assessment of Tremor Severity Following Transcutaneous Stimulation
Essential Tremor Assessment Following Transcutaneous Stimulation
Secondary outcome measures
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.

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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,386 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
~4 spots leftby Dec 2025