Binaural ear vagus nerve stimulation for sensory and motor problems after stroke
Official title: Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction
Run by Nanchang University Affiliated Rehabilitation Hospital · NCT07081568 · Data updated 2026-11-12
This trial will test whether synchronized electrical stimulation of the vagus nerve in both ears helps adults who recently had an ischemic stroke improve movement and feeling in affected limbs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Nanchang University Affiliated Rehabilitation Hospital Academic / other |
| Locations | 1 site (Nanchang, Jiangxi) |
| Status | Recruiting |
| Started | June 25, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 7, 2025 |
| Trial ID | NCT07081568 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with a first ischemic stroke 7–14 days after onset who have measurable sensory or motor deficits and intact skin at the stimulation sites are ideal candidates.
✕Probably not a fit
Patients with severe cognitive impairment, implanted intracranial devices or metal implants, uncontrolled involuntary movements, or fractures limiting limb movement are excluded and may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Forty adults with a first ischemic stroke 7–14 days after onset will be randomized 1:1 to receive either synchronized transcutaneous auricular vagus nerve stimulation to both ears or a sham (false) stimulation using the same device. The design is double-blind with patients, outcome evaluators, and statisticians masked; allocation is concealed with preset device modes and opaque envelopes. Treatments are delivered at the Affiliated Rehabilitation Hospital of Nanchang University using a standardized binaural VNS device, and clinical sensory and motor outcomes will be compared between groups. Safety, tolerability, and functional recovery measures will be recorded over the study period.
Why it matters
Potential benefit: If successful, this approach could speed recovery of motor and sensory function after stroke and reduce long-term disability.
How similar studies have gone: Related vagus nerve stimulation approaches have shown promising results for post-stroke motor recovery in prior studies, but synchronized binaural auricular stimulation is relatively novel and less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with first-episode ischemic stroke within 7 to 14 days of onset; * Be over 18 years old; * The skin at the irritated area remains intact; * The informed consent form has been signed. Exclusion Criteria: * Severe cognitive dysfunction (Mini-Mental State Examination≥19); * Peripheral limb movement limiting factors (fractures); * History of major neurological and mental disorders in the past; * Uncontrollable limb and facial muscle twitching, and spontaneous profuse sweating; * Intracranial shunt pumps, metal implants
Where it's running
-
The Fourth Affiliated Rehabilitation Hospital of Nanchang University
Nanchang, Jiangxi, China Recruiting
Study contacts
- Study coordinator: Han Jinjing Attending Physician
- Email: 515476321@qq.com
- Phone: 13672202061
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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.