Original Department of Neurosurgery, Xuanwu Hospital 2024-04-24 18:01 Beijing

Research background

Vagus nerve stimulation (VNS) has been mainly applied to epilepsy treatment in the past. Animal experiments have found that vagus nerve stimulation combined with motor training can cause neural function remodeling in animals and improve the recovery of locomotion in ischemic stroke models. The latest foreign multicenter clinical trials have confirmed that vagus nerve stimulation combined with intensive upper limb rehabilitation can significantly improve upper limb motor function in patients with moderate to severe long-term arm impairment after ischemic stroke. In 2021, the U.S. Food and Drug Administration has approved the use of the VNS device manufactured by Vivistim in the treatment of moderate-to-severe upper extremity motor dysfunction after chronic ischemic stroke.

Research Programs

Xuanwu Hospital of Capital Medical University is conducting an exploratory IIT study for the recovery of upper limb motor function in ischemic stroke patients. The study, initiated by Professor Shan Yongzhi of the Department of Neurosurgery, Xuanwu Hospital of Capital Medical University, has been approved by the Ethics Committee (Ethics No. Pro-Research and Review [2024] 008-Preliminary-Research-002), and is planned to recruit 10 ischemic stroke patients with the aim of validating the feasibility, safety, and efficacy of vagal nerve stimulation combined with simultaneous rehabilitation training in the recovery of motor function in stroke patients.

Inclusion criteria

Aged between 20 and 70 years old;

Prior history of unilateral supratentorial ischemic stroke of 3 - 60 months with current stable condition;

Weakness of the right or left limb with an FMA motor function score (which is a scale to assess sensory-motor deficits of the limb) of 30 - 80;   

Ability to communicate, understand and give appropriate consent;

Fully informed preoperative consent, voluntary signed informed consent and no contraindications to surgery.

(Please consult the study physician for specific inclusion or exclusion criteria.)

Subject’s benefits

Those who sign up will be provided with priority access to surgery and rehabilitation;

Those who are eligible for inclusion will have access to certain equipment support;

Those who are eligible for inclusion will be compensated by Pinchot for appropriate transportation;

Those who are eligible for inclusion will be provided with medical device clinical trial liability insurance.

Obligations of subjects

Cooperate with relevant examinations

Cooperate with rehabilitation treatment

Cooperate with the follow-up requests

Contact information

If you would like to learn more about this study or meet the above criteria and are interested in participating in the study, please call for a consultation;

Contact: Dr. Shi (same number as WeChat): 16619783686.

Consultations can also be made through outpatient registration (in chronological order)

Monday morning Prof. Yongzhi Shan, renowned expert in neurosurgery

Tuesday afternoon Special Needs Clinic - Prof. Zhao Guoguang

Wednesday afternoon and Friday morning Epilepsy Surgery Specialized Clinic-team doctors’ visit