Trials / Completed
CompletedNCT03597100
Prospective Study for Symptomatic Relief of ET With Cala Therapy
Prospective Study for Symptomatic Relief of Essential Tremor With Cala Therapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 263 (actual)
- Sponsor
- Cala Health, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cala TWO | Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves |
Timeline
- Start date
- 2018-12-14
- Primary completion
- 2019-05-29
- Completion
- 2019-05-29
- First posted
- 2018-07-24
- Last updated
- 2023-10-12
- Results posted
- 2023-10-12
Locations
32 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03597100. Inclusion in this directory is not an endorsement.