Efficacy and Safety of Deep Brain Stimulation in Mesencephalic Locomotor Region（MLR） for Poststroke Hemiplegia

Stroke Sequelae Clinical Trial

Official title: A Randomized Controlled Trial Exploring the Efficacy and Safety of Deep Brain Stimulation in the Treatment of Motor Dysfunction After Stroke#the PASTS-Stroke Study#

Status Not yet recruiting

Clinical Trial Summary

Abstract: Background: The leftover movement disorder of stroke patients is one of the main causes of disability, and there is still no specific solution. Studies have shown that the improvement of movement disorder symptoms in patients receiving DBS is a potential therapy. treatment approach. However, at present, there are few large-sample studies in this area at home and abroad, which cannot well reveal its actual therapeutic effect and safety, and do not fully understand its potential neural mechanisms, so it is impossible to form a unified and standardized treatment standard, which limits its wide application in clinical practice. Objectives: This study aimed to determine the efficacy and safety of hemiplegia recovery after deep brain electrical stimulation in stroke patients with hemiplegia. Methods/Design: This was a double-blind randomized cross-over controlled pilot study in which 62 patients were assigned to receive deep brain stimulation (DBS) and randomized into DBS and control groups using a randomized controlled study approach, DBS group One month after the operation, electrical stimulation was started, and the control group was given sham stimulation treatment. After 3 and 6 months of follow-up, all the machines were turned off. After a 2-week washout period, the control group was turned on, but the DBS group was given sham stimulation. After the 9th and 12th month of follow-up, all patients were given start-up treatment, and neuroimaging and various post-stroke motor-related scores were performed for data collection and analysis. Discussion: The investigators propose a research design and rationale to explore the effectiveness and safety of DBS in patients with post-stroke hemiplegia, and provide evidence and reference for DBS in the treatment of post-stroke dyskinesia. Study limitations are related to the small sample size and short study time period.

Clinical Trial Description

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 make it difficult for patients to adhere to treatment, and the treatment effect is poor.Deep Brain Stimulation (DBS) therapy has 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 in the treatment of poststroke motor dysfunction have not been verified by clinical randomized controlled trials.

The invstigators plan to design a multicenter, prospective, randomized, parallel- controlled equivalent clinical trial, aiming to to explore the efficacy and safety of DBS 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 deep brain stimulation (DBS) in patients with post-stroke motor dysfunction. The primary objective was to determine the effectiveness and safety of deep brain stimulation (DBS) for improving motor dysfunction in stroke patients. The secondary purpose is to explore the mechanism of deep brain stimulation (DBS) in the treatment of 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 62 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 conventional rehabilitation group. The DBS electrodes will be implanted into MLR.The other operation procedures and subsequent follow-up plan are the same. The DBS device will be switched on in four weeks postoperatively and the optimal stimulation parameters will be used. The invstigators will record standardized videos and/or complete a series of clinical scales (see outcome measures) for all patients at baseline, one month postoperatively (after activation of DBS device), three months postoperatively, six months postoperatively, and one year postoperatively. Meanwhile, the stimulation parameters and adverse effects will also be documented.Finally, two professional raters will assess the severity at different timepoints according to those standardized videos in a blind manner.Intention-to-treatment analysis and per protocol analysis are both conducted by a professional data analyst. ;

Related Conditions & MeSH terms

• Hemiplegia
• Stroke
• Stroke Sequelae

• NCT number: NCT05968248
• Study type: Interventional
• Source: Chinese PLA General Hospital
• Contact: Zhiqi Mao, PhD
• Phone: 8618910155994
• Email: markmaoqi@126.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 10, 2023
• Completion date: November 11, 2027