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NCT02629614 · ClinicalTrials.gov registry record · NA

Cala ONE Device for Essential Tremor

A NA study, sponsored by Cala Health.

Completed
Registry status
NA
Development phase
93
Enrollment target

NCT02629614: Completed NA study, sponsored by Cala Health.

NCT02629614 is a NA study that has completed, run by Cala Health. The registered enrollment target is 93 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02629614, a NA study, has completed, sponsored by Cala Health.

COMPLETED
Registry status
NA
Development phase
93 participants
Enrollment target

Study Summary

This study evaluates the safety and effectiveness of the Cala ONE device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. This study is a prospective, randomized, double-blinded, sham-controlled study.

Primary Outcome

The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters). The Essential Tremor Rating Assessment Scale (TETRAS) is a commonly used scale to assess and measure the severity of essential tremor. Each task was calculated individually on a 0-4 scale, with higher scores indicating more severe tremors.

Interventions

  • DEVICE Cala ONE Device

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2016-04
Est. Completion 2016-11
Phase NA
Cala Health

6 total trials

What the finished NCT02629614 record still lists

NCT02629614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

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

NCT02629614 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02629614 about?

NCT02629614 is a clinical study titled "Cala ONE Device for Essential Tremor". This study evaluates the safety and effectiveness of the Cala ONE device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. This study is a prospective, randomized, double-blinded, sham-controlled study.

What is the current status of trial NCT02629614?

This trial is currently completed. It is a NA study. The enrollment target is 93 participants. The study started on 2016-04. Estimated completion is 2016-11.

What interventions are being tested in trial NCT02629614?

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

Who is sponsoring clinical trial NCT02629614?

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

How this trial's enrollment target compares

Where NCT02629614's enrollment target sits among peer trials

93 937th of 2000 higher than 1,064 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02629614, the US trial registry maintained by the National Library of Medicine. NCT02629614 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.