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

Not Applicable

• Conditions: Cerebrovascular Disease; Transcranial Direct Current Stimulation; Gait Dysfunction, Neurologic; Repetitive Transcranial Magnetic Stimulation
• Interventions: Device: Sham tDCS; Device: Active rTMS; Device: Sham rTMS; Device: Active tDCS; Other: Walking training; Other: Cognition training

• Registration Number: NCT04282538
• Lead Sponsor: zsneurology

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.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-07-25
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-21
• Last Update Submitted: 2020-02-21
• Study First Posted: 2020-02-24
• Last Update Posted: 2020-02-24
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B - Active	Cognition training	Active tDCS for Frontal Gait Dysfunction
Group B - Sham	Sham tDCS	Sham tDCS for Frontal Gait Dysfunction
Group A - Active	Active rTMS	Active rTMS for Gait Dysfunction of Hemiplegia
Group A - Sham	Sham rTMS	Sham rTMS for Gait Dysfunction of Hemiplegia
Group A - Sham	Walking training	Sham rTMS for Gait Dysfunction of Hemiplegia
Group B - Active	Active tDCS	Active tDCS for Frontal Gait Dysfunction
Group A - Active	Walking training	Active rTMS for Gait Dysfunction of Hemiplegia
Group B - Active	Walking training	Active tDCS for Frontal Gait Dysfunction
Group B - Sham	Walking training	Sham tDCS for Frontal Gait Dysfunction
Group B - Sham	Cognition training	Sham tDCS for Frontal Gait Dysfunction

Primary Outcome Measures

Name	Time	Method
Velocity of 10m walking test	12 weeks	Velocity of 10m walking test (10MWT) according to the video

Secondary Outcome Measures

Name	Time	Method
Montreal cognitive assessment (MoCA)	12 weeks	Cognition evaluation according to Montreal cognitive assessment (Full score: 30. score \<26 indicates cognitive impairment.
Turn time of time up and go test	12 weeks	Total time, pace, standing time, turn time of time up and go test (TUGT) according to the video
Dual-task walking	12 weeks	Pace, step width, step size, step frequency, dual task cost of dual-task walking (DTW) according to the video
Instrumental activities of daily living (IADL)	12 weeks	Daily living ability evaluation according to Instrumental activities of daily living (Full score: 24. Higher score indicates higher independence. )
Tinetti Balance and Gait Analysis	12 weeks	Gait evaluation according to Tinetti Balance and Gait Analysis (Full score: 28. score \>= 19 indicates high risk of fall.)
10m walking test	12 weeks	Step width, step size, step frequency of 10m walking test (10MWT) according to the video
Mini-mental state examination (MMSE)	12 weeks	Cognition evaluation according to Mini-mental state examination (Full score: 30. score \<24 indicates cognitive impairment. )
Symbol digit modalities test (SDMT)	12 weeks	Attention evaluation according to Symbol digit modalities test (Counting number of right modalities in 90s. )
Hamilton depression scale (HAMD)	12 weeks	Mood evaluation according to Hamilton depression scale (Score \>7 indicates possible depression.)
Color word test (CWT)	12 weeks	Execution evaluation according to Color word test (Counting number of right ones. )

Trial Locations

Locations (6)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Eighth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Huadong Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Xuhui District Central Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China