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NCT03778060 · ClinicalTrials.gov registry record · NA

Long-Term Transcutaneous Stimulation and Essential Tremor: A PET Study

A NA study of Essential Tremor, sponsored by Mayo Clinic.

Active
Registry status
NA
Development phase
20
Enrollment target
1
Study location

NCT03778060 is a NA study of Essential Tremor that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 20 participants, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03778060, a NA study of Essential Tremor, is active but no longer recruiting, sponsored by Mayo Clinic.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
20 participants
Enrollment target
1
Study location

Study 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 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

Conditions Studied

Essential Tremor

Interventions

  • DEVICE Cala TWO stimulator

Study Locations (1)

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2019-02-11
Est. Completion 2026-12
Phase NA

Sponsor

Mayo Clinic

2,844 total trials

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What the Registry Record Tells You About NCT03778060

The ClinicalTrials.gov registry entry for NCT03778060 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (95% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Essential Tremor appearing as the primary indexed condition, and to 1 intervention - of which Cala TWO stimulator is the first listed.

NCT03778060 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT03778060 about?

NCT03778060 is a clinical study titled "Long-Term Transcutaneous Stimulation and Essential Tremor: A PET Study". 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 c...

What is the current status of trial NCT03778060?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2019-02-11. Estimated completion is 2026-12.

What conditions does trial NCT03778060 study?

This clinical trial studies the following conditions: Essential Tremor.

What interventions are being tested in trial NCT03778060?

The interventions under investigation include: Cala TWO stimulator (DEVICE).

Who is sponsoring clinical trial NCT03778060?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03778060 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.