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NCT03152136 · ClinicalTrials.gov registry record · NA

A Pilot Study of the Cala ONE Device for Essential Tremor

A NA study, sponsored by Cala Health.

Completed
Registry status
NA
Development phase
62
Enrollment target

NCT03152136 is a NA study that has completed, run by Cala Health. The registered enrollment target is 62 participants.

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The verdict

NCT03152136, a NA study, has completed, sponsored by Cala Health.

COMPLETED
Registry status
NA
Development phase
62 participants
Enrollment target

Study Summary

Prospective, multi-center, randomized, controlled study designed to evaluate safety and repeatable effectiveness. Subjects will be randomized 2:1:1 to transcutaneous afferent patterned stimulation (TAPS), sham, or 'no intervention', respectively. Subjects randomized to the TAPS and sham arms will be blinded to their randomization assignments for the first two weeks of participation (controlled phase). After the first two weeks, all subjects will be crossed over to TAPS (open-label phase) for 2 weeks. During study participation, all subjects are to remain on a stable dosage of medications prescribed for the treatment of essential tremor, if applicable.

Interventions

  • DEVICE Cala ONE device

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2017-07-26
Est. Completion 2018-03-08
Phase NA

Sponsor

Cala Health

6 total trials

What the Registry Record Tells You About NCT03152136

The ClinicalTrials.gov registry entry for NCT03152136 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cala Health, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Cala ONE device is the first listed.

NCT03152136 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03152136 about?

NCT03152136 is a clinical study titled "A Pilot Study of the Cala ONE Device for Essential Tremor". Prospective, multi-center, randomized, controlled study designed to evaluate safety and repeatable effectiveness. Subjects will be randomized 2:1:1 to transcutaneous afferent patterned stimulation (TAPS), sham, or 'no intervention', respectively. Subjects randomized to the TAPS and sham arms will be...

What is the current status of trial NCT03152136?

This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2017-07-26. Estimated completion is 2018-03-08.

What interventions are being tested in trial NCT03152136?

The interventions under investigation include: Cala ONE device (DEVICE).

Who is sponsoring clinical trial NCT03152136?

This trial is sponsored by Cala Health, which has 6 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.