Efficacy of rTMS and tDCS as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction
NCT ID: NCT04282538
Last Updated: 2020-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-12-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A - Active
Active rTMS for Gait Dysfunction of Hemiplegia
Active rTMS
4-week (5 days per week) active rTMS (90%rMT, M1, 10Hz for 10s, 50s interval, 20 trains)
Walking training
4-week (5 days per week) walking training
Group A - Sham
Sham rTMS for Gait Dysfunction of Hemiplegia
Sham rTMS
4-week (5 days per week) sham rTMS
Walking training
4-week (5 days per week) walking training
Group B - Active
Active tDCS for Frontal Gait Dysfunction
Active tDCS
4-week (5 days per week) active tDCS (2mA, DLPFC, 20 min)
Walking training
4-week (5 days per week) walking training
Cognition training
4-week (5 days per week) cognition training
Group B - Sham
Sham tDCS for Frontal Gait Dysfunction
Sham tDCS
4-week (5 days per week) sham tDCS
Walking training
4-week (5 days per week) walking training
Cognition training
4-week (5 days per week) cognition training
Interventions
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Active rTMS
4-week (5 days per week) active rTMS (90%rMT, M1, 10Hz for 10s, 50s interval, 20 trains)
Sham rTMS
4-week (5 days per week) sham rTMS
Active tDCS
4-week (5 days per week) active tDCS (2mA, DLPFC, 20 min)
Sham tDCS
4-week (5 days per week) sham tDCS
Walking training
4-week (5 days per week) walking training
Cognition training
4-week (5 days per week) cognition training
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
75 Years
ALL
No
Sponsors
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zsneurology
OTHER
Responsible Party
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zsneurology
Medical doctor
Principal Investigators
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Xin Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanghai Eighth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Huadong Hospital
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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XIn Wang, MD
Role: primary
Jie Shen, MD
Role: primary
JieJiao Zheng, MD
Role: primary
YuWu Zhao, MD
Role: primary
Xueyuan Liu, MD
Role: primary
Jian Yang, MD
Role: primary
Other Identifiers
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17411953800
Identifier Type: -
Identifier Source: org_study_id
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