Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT03778060
Eligibility Criteria:
Subject population (children, adults, groups): Adults approved for DBS surgery at Mayo Clinic for treatment of essential tremor
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT03778060
Study Brief:
Protocol Section:
NCT03778060