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Transcutaneous Stimulation for Essential Tremor
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.
- Essential Tremor
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.Adults eligible for deep brain stimulation (DBS) surgery at Mayo Clinic to treat essential tremorYou are able to understand the study and agree to participate by signing a form.You have been suspected or diagnosed with epilepsy or other seizure disorder.You have a serious problem with alcohol, as determined by specific criteria in the DSM-5.You have a medical device like a pacemaker or defibrillator implanted in your body.You had a botulinum toxin injection for hand tremor within the 6 months before the study starts.You have another brain disease that affects movement or memory, like Parkinson's plus syndromes, dementia with Lewy bodies, or Alzheimer's disease.You have had a specific type of brain surgery to treat tremors in the past.You have had a lot of alcohol or caffeine within 8 hours before the study, which could affect the study results.If you take medication for tremors, you should have been on the same dose for at least 30 days before joining the study.If you take antidepressant medications, you must have been on the same dose for at least 90 days before joining the study.Criterion: You must be 21 years old or older and approved for deep brain stimulation (DBS) surgery at Mayo Clinic to treat essential tremor.You agree to follow the instructions of the study, which includes not changing your dose of tremor and antidepressant medication (if you take them), avoiding alcohol and caffeine 8 hours before study visits and not using the Cala TWO device 8 hours before study visits.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- Group 1: Transcutaneous stimulation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
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."
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."
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."
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."
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