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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: Completed NA study, sponsored by Cala Health.
NCT03152136 is a NA study that has completed, run by Cala Health. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
For TAPS and sham arms, subjects will be prompted to perform a lateral postural hold prior to entering their PGI-S score before and after each stimulation session. During this hold, the device will record motion data to objectively assess if there are any changes in tremor level.
Interventions
- DEVICE Cala ONE device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2017-07-26 |
| Est. Completion | 2018-03-08 |
| Phase | NA |
What the finished NCT03152136 record still lists
NCT03152136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Cala ONE device is the first listed.
NCT03152136 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03152136's enrollment target sits among peer trials
62 1157th of 2000 higher than 837 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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