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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
4-week (5 days per week) active rTMS (90%rMT, M1, 10Hz for 10s, 50s interval, 20 trains)
4-week (5 days per week) sham rTMS
4-week (5 days per week) active tDCS (2mA, DLPFC, 20 min)
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Eighth People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Huadong Hospital
Shanghai, Shanghai Municipality, China
Velocity of 10m walking test
Velocity of 10m walking test (10MWT) according to the video
Time frame: 12 weeks
10m walking test
Step width, step size, step frequency of 10m walking test (10MWT) according to the video
Time frame: 12 weeks
Turn time of time up and go test
Total time, pace, standing time, turn time of time up and go test (TUGT) according to the video
Time frame: 12 weeks
Dual-task walking
Pace, step width, step size, step frequency, dual task cost of dual-task walking (DTW) according to the video
Time frame: 12 weeks
Tinetti Balance and Gait Analysis
Gait evaluation according to Tinetti Balance and Gait Analysis (Full score: 28. score \>= 19 indicates high risk of fall.)
Time frame: 12 weeks
Mini-mental state examination (MMSE)
Cognition evaluation according to Mini-mental state examination (Full score: 30. score \<24 indicates cognitive impairment. )
Time frame: 12 weeks
Montreal cognitive assessment (MoCA)
Cognition evaluation according to Montreal cognitive assessment (Full score: 30. score \<26 indicates cognitive impairment.
Time frame: 12 weeks
Symbol digit modalities test (SDMT)
Attention evaluation according to Symbol digit modalities test (Counting number of right modalities in 90s. )
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4-week (5 days per week) sham tDCS
4-week (5 days per week) walking training
4-week (5 days per week) cognition training
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGTime frame: 12 weeks
Color word test (CWT)
Execution evaluation according to Color word test (Counting number of right ones. )
Time frame: 12 weeks
Hamilton depression scale (HAMD)
Mood evaluation according to Hamilton depression scale (Score \>7 indicates possible depression.)
Time frame: 12 weeks
Instrumental activities of daily living (IADL)
Daily living ability evaluation according to Instrumental activities of daily living (Full score: 24. Higher score indicates higher independence. )
Time frame: 12 weeks