CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Transcutaneous Vagus Nerve Stimulation (tVNS) +1 moredevice
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/NCT03592745
NCT03592745Phase 2Completed
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Evaluating the Use of Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Upper Limb Motor Recovery After Stroke

Northwell Health·interventional·Posted Jul 19, 2018·Updated Jun 29, 2021

In Brief

A Phase 2 clinical trial evaluating Transcutaneous Vagus Nerve Stimulation (tVNS) and Sham Transcutaneous Vagus Nerve Stimulation (tVNS) for Stroke and 2 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate if multiple therapy sessions of Transcutaneous Vagus Nerve Stimulation (tVNS) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy in a sham stimulation condition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Cerebrovascular Accident (CVA), Hemiparesis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 19, 2018
Enrollment StartAug 9, 2018
Primary CompletionJun 12, 2020
Study CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.0 years ago

Interventions

Transcutaneous Vagus Nerve Stimulation (tVNS)device

tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.

Sham Transcutaneous Vagus Nerve Stimulation (tVNS)device

tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.