Long-Term Transcutaneous Stimulation and Essential Tremor: A PET Study
Public ClinicalTrials.gov record NCT03778060. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Cala TWO Device: Clinical Efficacy and Effects on Regional Brain Metabolism in Essential Tremor Subjects Scheduled to Undergo Deep Brain Stimulation Surgery
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 can range from mildly limiting to severely disabling. Treatment options are limited and there are currently no medications specifically designed to treat it, and medications that are prescribed to relieve tremors are often limited by either inadequate efficacy or intolerable side effects. A subset of essential tremor patients whose tremors are inadequately treated by medication choose to undergo deep brain stimulation (DBS) of the ventral intermediate thalamic nucleus. DBS has been shown to be highly effective for tremor suppression. However, DBS carries significant risks. As a result, a very small (less than 3%) percentage of essential tremor patients undergo DBS therapy. The medical technology company Cala Health has developed a wristband device (the Cala TWO) that offers individuals with essential tremor a novel non-pharmacological, non-invasive alternative, in the form of stimulation of peripheral nerves, to aid in hand tremor relief. This innovative form of therapy has the potential to have important health, quality of life, and economic benefits for essential tremor patients. The present pilot study (Aim 1) will assess the effectiveness of 3-month twice daily treatment with the Cala TWO device to aid in the relief of hand tremors in adult essential tremor subjects that have been approved to undergo deep brain stimulation surgery at Mayo Clinic - Rochester. This study is a prospective, within subject, non-significant risk study at Mayo Clinic - Rochester, enrolling approximately 20 subjects. A completely optional component of this study (Aim 2) is seeking to perform three standard PET/CT sessions on a subset of these subjects (n=10) at Mayo Clinic - Rochester to evaluate changes in brain metabolic activity as a result of 3 months treatment with the device. The first session would take place upon a subjects entry into the study (start of month 1) and prior to any treatment with the Cala device, a second the following day after a 40 minute treatment period with the Cala device, and a third session at the end of the third month. This study is a prospective, within subject, greater than minimum risk study.
Study identification
- NCT ID
- NCT03778060
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 10, 2019
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Jan 29, 2026
2019 – 2026
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03778060, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 29, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03778060 live on ClinicalTrials.gov.