NCT04282538Unknown不适用
Efficacy of Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction
zsneurology6 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Velocity of 10m walking test
研究概览
简要总结
This study was a prospective, randomized, single-blind, parallel-controlled, multicenter clinical study to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation and transcranial direct current stimulation assisted rehabilitation in the treatment of cerebrovascular disease-related gait disorders.
详细描述
This study was a prospective, randomized, single-blind, parallel-controlled, multicenter clinical study. The main purpose was to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation and transcranial direct current stimulation assisted rehabilitation in the treatment of cerebrovascular disease-related gait disorders. The secondary objective was to assess the effects of these two types of neuromodulation on cognitive, emotional, and daily living abilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group A: Gait Dysfunction of Hemiplegia
- •Age ≥ 35 years old, ≤ 75 years old;
- •There was a cerebral infarction event in the past ≥ 2 months, leaving unilateral lower extremity paralysis, muscle strength IV to V- grade;
- •Brunnstrom staging: lower limb of paralysis (IV-V grade), lower limb of healthy side (IV-V grade), upper limbs (IV-V grade), hands (IV-V grade);
- •Able to stand for 5 minutes without assistance, without gait aid, and to walk independently for 5 minutes without stopping;
- •Mini-mental state examination (MMSE) > 17 points, able to complete cognitive and gait assessments.
- •Group B: Frontal Gait Dysfunction
- •Age ≥ 35 years old, ≤ 75 years old;
- •Meet the frontal gait characteristics: a) Balance dysfunction: wide step base, trunk swing, increased fall, decreased trunk movement control, and autonomous activity dysfunction; b) difficulty in starting, dragging and freezing; c) without limb ataxia, dysarthria, nystagmus, decreased facial expression, decreased upper limb joint activity, upper motor neuron impaired signs, and resting tremor;
- •There was a cerebral infarction event ≥ 2 months, or asymptomatic stroke event but the head MRI suggested single or multiple lacunar infarction or ischemic lesion (diameter ≤ 2cm);
- •limb muscle strength V- to V grade, and the muscle strength of both limbs is the same;
- •Able to stand for 5 minutes without assistance, without gait aid, to walk independently for 5 minutes;
- •Able to complete cognitive and gait assessments.
排除标准
- •Other gait abnormalities caused by other diseases, such as Parkinson's disease, hydrocephalus, cerebellar disease, vestibular system disease, extrapyramidal abnormalities, abnormalities of proprioceptive sensibility, visual abnormalities, auditory abnormalities, peripheral nerves and musculoskeletal diseases;
- •Symptomatic cerebral infarction <2 months; Severe nervous system diseases, such as previous cerebral hemorrhage, history of subarachnoid hemorrhage, craniocerebral trauma, cerebral vascular malformation, brain tumor, central nervous system infection, demyelinating disease, epilepsy, myelopathy, etc.;
- •Severe cognitive impairment, major depression, and aphasia disable to finish the cognitive and gait assessments;
- •serious cardiovascular, pulmonary, blood, rheumatism and other complications, pregnancy;
- •Metal implants such as pacemakers or cochlear implants;
- •Taking drugs that affect cortical excitability: such as antiepileptic drugs, sedation, benzodiazepines, antidepressants, dopamine, amphetamines, etc.;
- •long-term heavy drinking: the alcohol content of men drinking more than 168g per week, women more than 112g;
- •Neurological rehabilitation treatment was received within 1 month before the start of the trial.
结局指标
主要结局
Velocity of 10m walking test
时间窗: 12 weeks
Velocity of 10m walking test (10MWT) according to the video
次要结局
- Montreal cognitive assessment (MoCA)(12 weeks)
- Turn time of time up and go test(12 weeks)
- Dual-task walking(12 weeks)
- Instrumental activities of daily living (IADL)(12 weeks)
- Tinetti Balance and Gait Analysis(12 weeks)
- 10m walking test(12 weeks)
- Mini-mental state examination (MMSE)(12 weeks)
- Symbol digit modalities test (SDMT)(12 weeks)
- Hamilton depression scale (HAMD)(12 weeks)
- Color word test (CWT)(12 weeks)
研究者
zsneurology
Medical doctor
Shanghai Zhongshan Hospital
研究点 (6)
Loading locations...
相似试验
招募中
不适用
rTMS With and Without Text4Support for the Treatment of Resistant Depression.Depressive Disorder, Treatment-ResistantNCT05570344University of Alberta200
进行中（未招募）
不适用
Trans cranial magnetic stimulation in bipolar depressioISRCTN16011816Amsterdam UMC Location VUmc166
已完成
不适用
Efficacy of Repetitive Transcranial Magnetic Stimulation to Reduce Muscle SpasticityIRCT20171215037872N1Shiraz University of Medical Sciences40
已完成
不适用
Efficacy of Repetitive Transcranial Magnetic Stimulation in Treating Refractory Obsessive Compulsive DisorderIRCT201308041743N11Research center for behavioral disorders and substance abuse, Hamadan University of Medical Science21
招募中
3 期
Effect of repetitive transcranial magnetic stimulation in children with generalised dystoniaCTRI/2022/01/039806Child Neurology Division