Using non-invasive vagus nerve stimulation with motor training to help stroke patients regain upper limb function
A Randomized, Double-blind Controlled Trial Investigating the Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Improving Upper Extremity Motor Function in Stroke Patients
This study is testing if using a gentle electrical stimulation on the ear, along with movement training, can help stroke patients regain better use of their arms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05943431 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) combined with motor training for improving upper extremity function in patients recovering from ischemic stroke. The approach utilizes non-invasive electrical stimulation to target the vagus nerve, aiming to enhance motor recovery without the need for surgical intervention. Participants will be randomly assigned to receive either paired taVNS, unpaired taVNS, or sham taVNS during their rehabilitation process. The study seeks to determine if this innovative method can provide significant benefits over traditional rehabilitation techniques.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with ischemic stroke who are in the acute or recovery phase and have unilateral upper limb dysfunction.
Not a fit: Patients with significant cognitive impairments, other neuropsychiatric disorders, or those who have received prior neuromodulation treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved motor function and quality of life for stroke patients with upper extremity dysfunction.
How similar studies have performed: Previous studies have shown promising results with vagus nerve stimulation techniques, suggesting that this approach may be effective, although taVNS itself is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with ischemic stroke according to a clinically qualified physician with reference to the Chinese Stroke Prevention and Control Guideline (2021). * Patients in the acute/recovery phase (after 2 weeks of onset) with stable signs; * No previous neuropsychiatric-related diseases; * No significant impairment of cognitive function and able to cooperate in completing the corresponding rehabilitation training; * With unilateral upper limb dysfunction; * Patients who have not received various neuromodulation rehabilitation treatments; * No contraindications to taVNS; * Patients voluntarily cooperated with the study and signed an informed consent form. Exclusion Criteria: * Patients have other mental health disorders (dementia, Parkinson's disease, depression, schizophrenia, bipolar disorder, etc.) * Patients have uncontrolled epilepsy, i.e., having had a seizure within 4 weeks prior to enrollment * Patients have cardiac arrhythmias or other abnormalities * Patients have a history of respiratory disease or disorder, including dyspnea and asthma; * The presence of gastrointestinal disorders such as diarrhea and vomiting that make it difficult for the patient to cooperate * Patients have a history of vasovagal syncope * Patients are under treatment with other neurostimulation/modulation * The presence of severe spasticity, other serious injuries to the upper extremities, or other medical conditions * Patients have difficulty in communication and understanding and inability to cooperate in completing the test; * Women who are pregnant or breastfeeding.
Where this trial is running
Guangzhou, Guangdong
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Qiuyou Xie, PhD — Southern Medical University, China
- Study coordinator: Xue-Zhen XIAO, PhD
- Email: xuezhenxiao@brainclos.com
- Phone: +8613425122570
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.