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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
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.
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 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).
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
3,239 Previous Clinical Trials
3,771,579 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
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Eligibility Criteria:
This trial includes the following eligibility 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.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.
Timeline:
This trial has the following timeline:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Transcutaneous stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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