Efficacy of rTMS and tDCS as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction
Efficacy of rTMS and tDCS as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction
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.
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.
Inclusion Criteria:

 1. 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.

 2. 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.