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Prospective Study for Symptomatic Relief of ET With Cala Therapy

NCT03597100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2023-10-12

Study results available
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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

DEVICE

Cala TWO

Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves

Sponsors & Collaborators

  • Cala Health, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-14
Primary Completion
2019-05-29
Completion
2019-05-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03597100 on ClinicalTrials.gov