The incidence of stroke has been more than 20 million stroke patients worldwide, and it has become the third highest-burden disease in the world. The disability rate of stroke is as high as 60-80%. The movement disorder left by the disease is the main reason for the high burden of the disease. At present, there is no particularly obvious and effective treatment measure in clinical practice.
If it is not treated in time, it may lead to permanent disability. The high cost of traditional rehabilitation and the fatigue of rehabilitation training institutions and family commuting makes it difficult for patients to adhere to and the treatment effect is poor. Deep Brain Stimulation (DBS)and vagal nerve stimulation (VNS) therapy have achieved good therapeutic effects in many diseases that were considered difficult to treat in the past, such as Parkinson's, depression, and other diseases, so it is applied to In the treatment of motor function recovery after stroke, many animal experiments and human clinical studies have confirmed its efficacy. However, the efficacy and safety of DBS and VNS in the treatment of poststroke motor dysfunction have not been verified by clinical randomized controlled trials.
The investigators plan to design a multicenter, prospective, randomized, parallel controlled equivalent clinical trial, aiming to explore the efficacy and safety of DBS and VNS in the treatment of motor dysfunction after stroke in the following aspects:(1) improvement rate of hemiplegia after stroke (2) improvement rate of life quality, mental and cognitive status, (3)stimulation parameters, (4) adverse effects. The main purpose of our design of this study was to provide more clinical evidence for the use of DBS and VNS in patients with post-stroke motor dysfunction. The primary objective was to determine the effectiveness and safety of DBS and VNS for improving motor dysfunction in stroke patients. The secondary purpose is to explore the mechanism of DBS and VNS in the treatment of the neurological function of post-stroke motor impairment and the improvement of the quality of life and psychosocial status of patients. According to the inclusion and exclusion criteria, the investigators aimed to collect 98 patients who were diagnosed with stroke and left with motor dysfunction. All patients included in the study will undergo DBS implantation after baseline assessment, and then will be randomly divided into 2 groups at a ratio of 1:1: DBS treatment group and VNS group. After 3 and 6 months of follow-up, all the devices are turned off. After a 2-week washout, the control group is turned on, but the stimulation group is given sham stimulation. After 9 and 12 months of follow-up, all the devices are turned on. The investigators will record standardized videos and/or complete a series of clinical scales (see outcome measures) for all patients at baseline, one month postoperatively, three months postoperatively, six months postoperatively, and one year postoperatively. Then, at postoperative 15 and 18 months, postoperative neuroimaging and various post-stroke motor-related scores were performed for data collection and analysis. Meanwhile, the stimulation parameters and adverse effects will also be documented. Finally, two professional raters will assess the severity at different time points according to those standardized videos in a blind manner. Intention-to-treatment analysis and protocol analysis are both conducted by a professional data analyst.
