CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 263 enrolled
Drug / intervention
Cala TWOdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03597100
NCT03597100N/ACompleted
CompareCT.gov

Prospective Study for Symptomatic Relief of Essential Tremor With Cala Therapy

Cala Health, Inc.·interventional·Posted Jul 24, 2018·Updated Oct 12, 2023

In Brief

A clinical study evaluating Cala TWO for Essential Tremor. Completed, enrolled 263 participants across 32 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEssential Tremor
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 24, 2018
Enrollment StartDec 14, 2018
Primary CompletionMay 29, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.9 years ago

Interventions

Cala TWOdevice

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