NCT04282538
Unknown
Not Applicable
Efficacy of Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction
zsneurology6 sites in 1 country100 target enrollmentDecember 1, 2018
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Repetitive Transcranial Magnetic Stimulation
- Sponsor
- zsneurology
- Enrollment
- 100
- Locations
- 6
- Primary Endpoint
- Velocity of 10m walking test
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
zsneurology
Medical doctor
Shanghai Zhongshan Hospital
Eligibility Criteria
Inclusion Criteria
- •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);
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Velocity of 10m walking test
Time Frame: 12 weeks
Velocity of 10m walking test (10MWT) according to the video
Secondary Outcomes
- 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)
Study Sites (6)
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