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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03597100
The ClinicalTrials.gov registry entry for NCT03597100 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 263 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 396-participant average among 41 other Essential Tremor trials with a reported enrollment target (34% lower). The listed sponsor is Cala Health, which has 6 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 is the first listed.
NCT03597100 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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