Status:
ACTIVE_NOT_RECRUITING
Long-Term Transcutaneous Stimulation and Essential Tremor: A PET Study
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Cala Health, Inc.
Conditions:
Essential Tremor
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
Essential tremor (ET) is the most common movement disorder in the United States and affects up to 5% of the population. ET patients experience involuntary shaking of the hands, head and/or voice that ...
Detailed Description
Hypothesis: The primary research question is whether customized patterned transcutaneous afferent electrical stimulation to the median and radial nerves via the Cala TWO wrist-band device significant...
Eligibility Criteria
Inclusion
- Subject population (children, adults, groups): Adults approved for DBS surgery at Mayo Clinic for treatment of essential tremor
- Prospective subjects must meet all of the following criteria to be eligible for study participation:
- Must be greater than or equal to 21 years of age. Must be approved for DBS surgery at Mayo Clinic for treatment of essential tremor.
- Competent and willing to provide signed, informed consent to participate in the study.
- Stable dose of tremor medications, if applicable, for 30 days prior to study entry.
- Stable dose of antidepressant medications, if applicable, for 90 days prior to study entry.
- Willing to comply with study protocol requirements including: remaining on a stable dosage of tremor and antidepressant medications, if applicable, during the duration of the study; no significant alcohol or caffeine consumption within 8 hours of study visits; no usage of the Cala TWO device within 8 hours of study visits.
Exclusion
- Prospective subjects that meet any of the following criteria are not eligible for enrollment in this study:
- Moderate to severe ethanol dependence as defined by the criteria outlined in the DSM-5 (score of 4 or higher).
- Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator.
- Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radiosurgical thalamotomy, and focused ultrasound for the treatment of tremor.
- Suspected or diagnosed epilepsy or other seizure disorder. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site (wrist).
- Peripheral neuropathy affecting the tested upper extremity. Presence of any other neurodegenerative disease like Parkinson plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
- Anyone suspected to have the diagnosis of idiopathic Parkinson's disease (PD). This includes excluding anyone with the presence of parkinsonian features including bradykinesia rigidity, or postural instability. Subjects that exhibit only mild resting tremor but no other symptoms or signs of PD may be included.
- Botulinum toxin injection for hand tremor within 6 months prior to study enrollment.
- Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Principal Investigator.
- Significant alcohol or caffeine consumption within 8 hours of study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee), and significant alcohol is considered more than 14 g (equivalent to 5 oz of wine, 12 oz of beer, or 1.5 oz of distilled spirits).
- Subjects unable to communicate with the investigator and staff. Any health condition that in the investigator's opinion should preclude participation in this study.
- Pregnancy or anticipated pregnancy during the course of the study.
Key Trial Info
Start Date :
February 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03778060
Start Date
February 11 2019
End Date
December 1 2026
Last Update
May 25 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905