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Effect of Vagus Nerve Stimulation Via the Outer Ear on Motor and Cognitive Deficits After Ischemic Stroke

NCT06822140 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-02-19

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) works to treat motor and neurocognitive deficits after ischemic stroke when applied within 30 days after onset of stroke.

The main questions it aims to answer are:

* Does tVNS improve motor deficits measured by the Fugl-Mayer assessment after ischemic stroke?
* Does tVNS ameliorate stroke-related cognitive impairment? Researchers will compare tVNS to a placebo (sham stimulation, i.e. an electrode is fixed on the ear without applying electrical impulses ) to see if tVNS works to treat motor and cognitive deficits after stroke .

Participants will:

* Receive tVNS or sham stimulation for 30 minutes 5 days a week during 5 weeks after ischemic stroke
* Receive smotor and cognitive training during the tVNS or sham stimulation
* Will take part on a standardized stroke rehabilitation program during the 5 weeks in a rehabilitation clinic.

Conditions

Interventions

DEVICE

transcutaneous auricular vagus nerve stimulation

Stimulation parameters: * Stimulating side: ipsilateral to the infarcted brain hemisphere * Location of pStimulation: Cymba conchae * Impulse shape: bi-phasic * Impulse intensity: at least 0.5 mA (max. 2.0 mA). * Impulse duration: 28 sec on, 32 sec off * Impulse frequency: 20-30 Hz.

DEVICE

sham-stimulation

An electrode is only attached to the ear without applying electrical impulses.

Sponsors & Collaborators

  • Rheinburg-Klinik

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2028-02-29
Completion
2028-04-30

Countries

  • Switzerland

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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 NCT06822140 on ClinicalTrials.gov