Trials / Completed
CompletedNCT02629614
Cala ONE Device for Essential Tremor
Multicenter Study of Safety and Effectiveness of Cala ONE Device for Essential Tremor
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- Cala Health, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2015-12-14
- Last updated
- 2023-07-18
- Results posted
- 2023-07-18
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02629614. Inclusion in this directory is not an endorsement.