NCT07132021

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universidade Federal de Pernambuco · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Stroke

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2025-08-20
• Last updated: 2025-08-20

Locations

1 site across 1 country: Brazil