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Behavioural Intervention

Transcutaneous Stimulation for Essential Tremor

N/A
Recruiting
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
Adults approved for DBS surgery at Mayo Clinic for treatment of essential tremor
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

Study 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.

Eligible Conditions
  • Essential Tremor

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Adults eligible for deep brain stimulation (DBS) surgery at Mayo Clinic to treat essential tremor

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.

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Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,031 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What demographic is most suitable for this research initiative?

"This trial is seeking 20 adults between 21 and 70 years old with familial tremor. Participants must be able to provide signed, informed consent for the study, have been deemed eligible for DBS surgery at Mayo Clinic to treat their essential tremor, take a stable dose of any prescribed tremour or antidepressant medications they may use in the month prior and three months before joining respectively, abstain from alcohol/caffeine 8 hours pre-study visits and not use their Cala TWO device during the same period."

Answered by AI

Does this study accept participants below the age of sixty?

"The cut-off age for consideration in this medical trial is 70, while the youngest participants must be 21 or older."

Answered by AI

Are any new enrollees being welcomed into this experiment?

"According to clinicaltrials.gov, the recruitment phase is currently ongoing for this research trial that was originally posted in February 11th 2019 and modified on February 18th 2022."

Answered by AI

How many participants is this study recruiting?

"Correct. Records on clinicaltrials.gov attest to this medical trial's active recruitment process, which started on the 11th of February 2019 and was most recently revised 18 days ago. This study requires 20 patients from a single research centre."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Did not meet criteria
~3 spots leftby Mar 2025