Binaural ear vagus nerve stimulation for sensory and motor problems after stroke
Research on Binaural Synchronous Vagus Nerve Regulation of Sensorimotor Disorders After Cerebral Infarction
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanchang University Affiliated Rehabilitation Hospital Academic / other |
| Locations | 1 site (Nanchang, Jiangxi) |
| Trial ID | NCT07081568 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nanchang, Jiangxi
- 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
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.