Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation, Cerebrovascular Disease, Gait Dysfunction, Neurologic
Conditions
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.
Interventions
DEVICEActive rTMS
4-week (5 days per week) active rTMS (90%rMT, M1, 10Hz for 10s, 50s interval, 20 trains)
DEVICESham rTMS
4-week (5 days per week) sham rTMS
DEVICEActive tDCS
4-week (5 days per week) active tDCS (2mA, DLPFC, 20 min)
DEVICESham tDCS
4-week (5 days per week) sham tDCS
OTHERWalking training
4-week (5 days per week) walking training
OTHERCognition training
4-week (5 days per week) cognition training
Sponsors
zsneurology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Velocity of 10m walking test | 12 weeks | Velocity of 10m walking test (10MWT) according to the video |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dual-task walking | 12 weeks | Pace, step width, step size, step frequency, dual task cost of dual-task walking (DTW) according to the video |
| 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.) |
| Mini-mental state examination (MMSE) | 12 weeks | Cognition evaluation according to Mini-mental state examination (Full score: 30. score \<24 indicates cognitive impairment. ) |
| 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 |
| Symbol digit modalities test (SDMT) | 12 weeks | Attention evaluation according to Symbol digit modalities test (Counting number of right modalities in 90s. ) |
| Color word test (CWT) | 12 weeks | Execution evaluation according to Color word test (Counting number of right ones. ) |
| Hamilton depression scale (HAMD) | 12 weeks | Mood evaluation according to Hamilton depression scale (Score \>7 indicates possible depression.) |
| 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. ) |
| 10m walking test | 12 weeks | Step width, step size, step frequency of 10m walking test (10MWT) according to the video |
Countries
China
Contacts
Primary ContactXin Wang, MD
Backup ContactJing Ding, MD
Outcome results
None listed