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

zsneurology

Status: Unknown

Conditions: Gait Dysfunction, Neurologic; Cerebrovascular Disease; Transcranial Direct Current Stimulation; Repetitive Transcranial Magnetic Stimulation

Treatments: Other: Cognition training; Other: Walking training; Device: Active tDCS; Device: Sham rTMS; Device: Sham tDCS; Device: Active rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT04282538

17411953800

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Group A - Active

Active Comparator group

Description:

Active rTMS for Gait Dysfunction of Hemiplegia

Treatment:

Device: Active rTMS

Other: Walking training

Group A - Sham

Sham Comparator group

Description:

Sham rTMS for Gait Dysfunction of Hemiplegia

Treatment:

Device: Sham rTMS

Other: Walking training

Group B - Active

Active Comparator group

Description:

Active tDCS for Frontal Gait Dysfunction

Treatment:

Other: Cognition training

Device: Active tDCS

Other: Walking training

Group B - Sham

Sham Comparator group

Description:

Sham tDCS for Frontal Gait Dysfunction

Treatment:

Other: Cognition training

Device: Sham tDCS

Other: Walking training