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Efficacy of Trans-auricular Vagus Nerve Stimulation on Upper Extremity Motor Recovery in Stroke Survivors

NCT07132021 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-04

No results posted yet for this study

Summary

The aim of this clinical trial is to determine if trans-auricular vagus nerve stimulation (taVNS) is effective in improving upper extremity function in stroke survivors. The primary objectives include: Investigating whether taVNS improves motor function in stroke survivors. The secondary objectives include: Assessing any potential side effects associated with the method. Investigating taVNS effects on daily routine functions and spasticity Researchers will conduct a comparative analysis between taVNS and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness. Participants in the trial will: Undergo taVNS combined with physical therapy or a sham procedure with physical therapy daily over a two-week period.

Conditions

Interventions

DEVICE

Active taVNS

Protocol uses a 25 Hz frequency with 500 μs pulse width in biphasic configuration, operating at a 1:1 duty cycle with current intensity set to the maximum tolerable level without inducing pain. The total stimulation duration is 60 minutes. The stimulation is combined with physical therapy focused on upper extremity function.

DEVICE

Sham taVNS

Physical therapy focused on upper extremity function with masking for transcutaneous vagus nerve stimulation

Sponsors & Collaborators

  • Fundação de Amparo à Ciência e Tecnologia de Pernambuco

    collaborator OTHER

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Universidade Federal de Pernambuco

    lead OTHER

Principal Investigators

  • Kátia Monte-Silva, PhD in Neurosciences · Universidade Federal de Pernambuco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-09-01
Completion
2026-12-01

Countries

  • Brazil

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 NCT07132021 on ClinicalTrials.gov