Trans-auricular vagus nerve stimulation to improve arm function after stroke
Efficacy of Trans-auricular Vagus Nerve Stimulation on Upper Extremity Motor Recovery in Stroke Survivors
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Universidade Federal de Pernambuco Academic / other |
| Locations | 1 site (Recife, Pernambuco) |
| Trial ID | NCT07132021 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Recife, Pernambuco
- Federal University of Pernambuco — Recife, Pernambuco, Brazil (Recruiting)
Study contacts
- Study coordinator: DANIEL G DE MELO, MsC
- Email: gmelodaniel@gmail.com
- Phone: +5581995173332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.