Cala ONE Device for Essential Tremor
NCT02629614 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93
Last updated 2023-07-18
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.
Conditions
Interventions
- DEVICE
-
Cala ONE Device
The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
Sponsors & Collaborators
-
Cala Health, Inc.
lead INDUSTRY
Principal Investigators
-
Lin, MD · Clinical Advisor
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-04-30
- Primary Completion
- 2016-11-30
- Completion
- 2016-11-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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