Trans-auricular vagus nerve stimulation to improve arm function after stroke
Official title: Efficacy of Trans-auricular Vagus Nerve Stimulation on Upper Extremity Motor Recovery in Stroke Survivors
Run by Universidade Federal de Pernambuco · NCT07132021 · Data updated 2026-11-12
This study will try trans-auricular vagus nerve stimulation plus physical therapy to see if it helps adults who had a stroke regain arm movement.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Universidade Federal de Pernambuco Academic / other |
| Locations | 1 site (Recife, Pernambuco) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | September 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT07132021 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with unilateral ischemic or hemorrhagic stroke onset within the past five years and persistent upper-extremity motor impairment who can participate in physical therapy and have no contraindications to taVNS.
✕Probably not a fit
People with other neurological disorders, significant cognitive deficits, peripheral upper-extremity injuries, recent botulinum toxin use, or recent medications that alter cortical excitability may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with unilateral ischemic or hemorrhagic stroke and upper extremity motor impairment (onset within five years) will receive either active trans-auricular vagus nerve stimulation (taVNS) or a sham procedure paired with daily physical therapy. Interventions are delivered over a two-week period with motor function as the primary outcome and safety, daily activities, and spasticity as secondary outcomes. The protocol compares active stimulation to a sham that mimics the procedure without therapeutic stimulation. Adverse events and tolerability will be monitored throughout the treatment period.
Why it matters
Potential benefit: If effective, this approach could improve upper-limb motor recovery and day-to-day function for stroke survivors.
How similar studies have gone: Early pilot studies and some trials of vagus nerve stimulation paired with rehabilitation (including noninvasive approaches) have shown promising but not yet definitive improvements in upper-limb recovery.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients aged between 18 and 75 years, with motor impairment in the upper extremity caused by unilateral ischemic or hemorrhagic stroke with stroke onset within the last five years. Exclusion Criteria: * Patients with any contraindication to taVNS, peripheral upper extremity injuries, use of medication affecting cortical excitability in the past 3 months, use of botulinum toxin in the past 3 months, presence of any other neurological disorder, or significant cognitive deficits.
Where it's running
-
Federal University of Pernambuco
Recife, Pernambuco, Brazil Recruiting
Study contacts
- Study coordinator: DANIEL G DE MELO, MsC
- Email: gmelodaniel@gmail.com
- Phone: +5581995173332
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.