Efficacy of rTMS and tDCS as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    zsneurology
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Updated on 16 February 2024
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transcranial magnetic stimulation
stroke
mini-mental state examination
transcranial direct current stimulation
infarct
hemiplegia
cerebral infarction
cerebrovascular disease
nystagmus
repetitive transcranial magnetic stimulation
dysarthria
lower limb
upper limb
lacunar infarction
head mri

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.

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.

Details
Condition Vascular Diseases, Vascular Diseases, Transcranial magnetic stimulation, Spastic gait, Cerebrovascular disease, Transcranial Direct Current Stimulation
Age 35years - 75years
Treatment Sham rTMS, Active tDCS, Sham tDCS, Active rTMS, Walking training, Cognition training
Clinical Study IdentifierNCT04282538
Sponsorzsneurology
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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)
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

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
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transcranial magnetic stimulation
stroke
mini-mental state examination
transcranial direct current stimulation
infarct
hemiplegia
cerebral infarction
cerebrovascular disease
nystagmus
repetitive transcranial magnetic stimulation
dysarthria
lower limb
upper limb
lacunar infarction
head mri

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