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NCT03597100 · ClinicalTrials.gov registry record · NA
Prospective Study for Symptomatic Relief of ET With Cala Therapy
A NA study of Essential Tremor, sponsored by Cala Health.
- Completed
- Registry status
- NA
- Development phase
- 263
- Enrollment target
- 20
- Study locations
NCT03597100: Completed NA study of Essential Tremor, sponsored by Cala Health.
NCT03597100 is a NA study of Essential Tremor that has completed, run by Cala Health. The registered enrollment target is 263 participants, below the 396-participant average among 41 other Essential Tremor trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03597100, a NA study of Essential Tremor, has completed, sponsored by Cala Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 263 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective, multi-center, single-arm, non-significant risk study designed to evaluate the Cala TWO device. Subjects will be screened for eligibility and fitted with a Cala TWO device. Subjects will wear the device at home for a period of 3 months, during which they will be asked to stimulate their dominant hand twice a day. The stimulation amplitude will be based on each subject's stimulation threshold. Subjects will have in clinic assessments at enrollment, month 1 and 3.
Primary Outcome
Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) subset score: TETRAS subset score relevant to the stimulated upper limb. The subset score is the sum of 6 rated tasks. Each task is rated 0 to 4, where a higher score indicates more severe tremor. Minimum subset score = 0; Maximum subset score = 24.
Conditions Studied
Interventions
- DEVICE Cala TWO
Study Locations (20)
California
- USC - Los Angeles
- Parkinson's Institute and Clinical Center - Mountain View
- University of California San Francisco - San Francisco
- Pacific Neuroscience Institute - Santa Monica
Florida
- Parkinson's Center - Boca Raton
- USF - Tampa
New York
- Parkinson's Disease and Movement Disorders Center of Long Island - Long Island City
- Mount Sinai & Beth Isreal - New York
Arizona
- Barrow Neurological Institute (Dignity Health) - Phoenix
Colorado
- Rocky Mountain Movement Disorders Center - Denver
Connecticut
- Hospital for Special Care - New Britain
District of Columbia
- Medstar Gerogetown Health Institute - Georgetown
Georgia
- Augusta University - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2018-12-14 |
| Est. Completion | 2019-05-29 |
| Phase | NA |
What the finished NCT03597100 record still lists
NCT03597100 is an interventional study that assigns participants to a tested intervention. The registered 263 participants enrollment target is mid-sized for trials with a published cap, below the 396-participant average among 41 other Essential Tremor trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Essential Tremor appearing as the primary indexed condition, and to 1 intervention - of which Cala TWO is the first listed.
NCT03597100 names 20 study sites across 15 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT03597100 about?
NCT03597100 is a clinical study titled "Prospective Study for Symptomatic Relief of ET With Cala Therapy". Prospective, multi-center, single-arm, non-significant risk study designed to evaluate the Cala TWO device. Subjects will be screened for eligibility and fitted with a Cala TWO device. Subjects will wear the device at home for a period of 3 months, during which they will be asked to stimulate their ...
What is the current status of trial NCT03597100?
This trial is currently completed. It is a NA study. The enrollment target is 263 participants. The study started on 2018-12-14. Estimated completion is 2019-05-29.
What conditions does trial NCT03597100 study?
This clinical trial studies the following conditions: Essential Tremor.
What interventions are being tested in trial NCT03597100?
The interventions under investigation include: Cala TWO (DEVICE).
Who is sponsoring clinical trial NCT03597100?
This trial is sponsored by Cala Health, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03597100 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03597100's enrollment target sits among peer trials
263 9th of 41 higher than 33 of 41 other Essential Tremor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Essential Tremor 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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