Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Prospective Study for Symptomatic Relief of ET With Cala Therapy
NCT03597100 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 263 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cala Health, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03597100 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03597100?
The interventions under investigation include: Cala TWO (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03597100?
This trial is sponsored by Cala Health, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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