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

Transcranial Direct Current Stimulation Clinical Trial

Official title:

Efficacy of Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04282538
• Other study ID #: 17411953800
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Xin Wang, MD
• Phone: 02164041991
• Email: wang.xin[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Disease
• Cerebrovascular Disorders
• Gait Disorders, Neurologic
• Gait Dysfunction, Neurologic
• Neurologic Manifestations
• Repetitive Transcranial Magnetic Stimulation
• Transcranial Direct Current Stimulation

Intervention

Device:
• 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

Other:
• Walking training
4-week (5 days per week) walking training
• Cognition training
4-week (5 days per week) cognition training

Locations

Country	Name	City	State
China	Shanghai Eighth People's Hospital	Shanghai	Shanghai
China	Shanghai Huadong Hospital	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai
China	Shanghai Xuhui District Central Hospital	Shanghai	Shanghai
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
zsneurology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Velocity of 10m walking test	Velocity of 10m walking test (10MWT) according to the video	12 weeks
Secondary	10m walking test	Step width, step size, step frequency of 10m walking test (10MWT) according to the video	12 weeks
Secondary	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	12 weeks
Secondary	Dual-task walking	Pace, step width, step size, step frequency, dual task cost of dual-task walking (DTW) according to the video	12 weeks
Secondary	Tinetti Balance and Gait Analysis	Gait evaluation according to Tinetti Balance and Gait Analysis (Full score: 28. score >= 19 indicates high risk of fall.)	12 weeks
Secondary	Mini-mental state examination (MMSE)	Cognition evaluation according to Mini-mental state examination (Full score: 30. score <24 indicates cognitive impairment. )	12 weeks
Secondary	Montreal cognitive assessment (MoCA)	Cognition evaluation according to Montreal cognitive assessment (Full score: 30. score <26 indicates cognitive impairment.	12 weeks
Secondary	Symbol digit modalities test (SDMT)	Attention evaluation according to Symbol digit modalities test (Counting number of right modalities in 90s. )	12 weeks
Secondary	Color word test (CWT)	Execution evaluation according to Color word test (Counting number of right ones. )	12 weeks
Secondary	Hamilton depression scale (HAMD)	Mood evaluation according to Hamilton depression scale (Score >7 indicates possible depression.)	12 weeks
Secondary	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. )	12 weeks