Compares two implanted brain and nerve stimulation methods for stroke hemiplegia

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 80 who have one-sided weakness or paralysis after a first stroke. They would receive an implanted brain or vagus nerve stimulator.

Age

18 to 80 years

Sex

Women and men can both join.

Disease stage

First one-sided stroke above the brainstem, ischemic or hemorrhagic. Stable after acute treatment. 6 months to 1 year since the stroke. NIHSS score from 2 to 20. Weakness of the paralysed muscles at grades 1 to 4. Able to walk at least 10 m with help from one or more people. Right-handed.

Earlier treatment

Usual rehabilitation before joining has helped little.

Main reasons for not taking part

• Dementia or mental illness that makes it hard to cooperate
• Stroke caused by injury or a brain tumor
• Serious illness such as cancer, or heart, liver, kidney or blood disease
• Pacemaker, defibrillator, metal implant or other implant affected by electrical impulses
• Pregnant or breast-feeding, or planning a birth soon

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 80 years old?YesNo

What the trial wants to find out

Background: Hemiplegia is a common complication after a stroke. Studies have shown that traditional medical and rehabilitation treatments are not good for improving patients' motor function, deep brain stimulation (DBS) and vagus nerve stimulation (VNS) can improve the motor function of patients, but there is no comparative study between them. Objectives: This study compares the efficacy and safety of DBS and VNS in the recovery of motor function in patients with post-stroke hemiplegia, determining the best treatment for patients with post-stroke hemiplegia, and providing high-level clinical evidence for patients and clinicians to choose from. Methods/Design: This is a randomized, double-blind, sham-controlled, cross-controlled pilot study. A total of 98 patients with post-stroke hemiplegia are assigned to receive DBS or VNS. 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. Then, at postoperative 15 and 18 months, postoperative neuroimaging and various post-stroke motor-related scores were performed for data collection and analysis. Discussion: We propose a study design and rationale to compare the efficacy and safety of DBS and VNS in patients with post-stroke hemiplegia to provide evidence and reference for implantable neuromodulation in the treatment of post-stroke dysfunction, and to compare the therapeutic effects of DBS and VNS to provide evidence for patient and clinical diagnosis and treatment choices. Study limitations are related to the small sample size and short study period.

The 2 groups in the trial

• The DBS electrodes are implanted into MLR.Treatment being tested

  The DBS electrodes are implanted into MLR.MLR-DBS#Deep brain stimulation of the mesencephalic locomotor region#The arm will be switched on one month postoperatively for electrical stimulation therapy, exercise training rehabilitation, and EMG-triggered neuromuscular stimulation. Specialist doctors will assess the patient's rehabilitation status through the telerehabilitation system every week, and provide, and guide on rehabilitation training and electrical stimulation therapy. Device: GPi-DBS devices DBS electrode: 3387 (Medtronic, Minneapolis, MN, USA) or L302 (PINS Medical, Beijing, China) or 1210(SceneRay, Suzhou, China); Extension wire: 37086 (Medtronic, Minneapolis, MN, USA) or E202 (PINS Medical, Beijing, China) or 1340/SR1341 (SceneRay, Suzhou, China); Implantable pulse generator: ACTIVA PC/RC (Medtronic, Minneapolis, MN, USA) or G102/G102R (PINS Medical, Beijing, China) or 1180/SR1101 (SceneRay, Suzhou, China).

• The electrodes are implanted into the patient's vagus nerveExisting treatment, for comparison

  The electrodes are implanted into the patient's vagus nerve. A pre-surgery assessment was performed. Device implantation was done under general anesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunneled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region