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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin Wang, MD; Phone Number: 02164041991; Email: wang.xin@zs-hospital.sh.cn
• Study Contact Backup: Name: Jing Ding, MD; Phone Number: 02164041991; Email: ding.jing@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Shanghai Zhongshan Hospital
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Sixth People's Hospital
      • Contact: YuWu Zhao, MD
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Tenth People's Hospital
      • Contact: Xueyuan Liu, MD
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Eighth People's Hospital
      • Contact: Jie Shen, MD
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Huadong Hospital
      • Contact: JieJiao Zheng, MD
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Xuhui District Central Hospital
      • Contact: Jian Yang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A - Active; Active rTMS for Gait Dysfunction of Hemiplegia	Device: Active rTMS; 4-week (5 days per week) active rTMS (90%rMT, M1, 10Hz for 10s, 50s interval, 20 trains); Other: Walking training; 4-week (5 days per week) walking training
Sham Comparator: Group A - Sham; Sham rTMS for Gait Dysfunction of Hemiplegia	Other: Walking training; 4-week (5 days per week) walking training; Device: Sham rTMS; 4-week (5 days per week) sham rTMS
Active Comparator: Group B - Active; Active tDCS for Frontal Gait Dysfunction	Other: Walking training; 4-week (5 days per week) walking training; Device: Active tDCS; 4-week (5 days per week) active tDCS (2mA, DLPFC, 20 min); Other: Cognition training; 4-week (5 days per week) cognition training
Sham Comparator: Group B - Sham; Sham tDCS for Frontal Gait Dysfunction	Other: Walking training; 4-week (5 days per week) walking training; Other: Cognition training; 4-week (5 days per week) cognition training; Device: Sham tDCS; 4-week (5 days per week) sham tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Velocity of 10m walking test	Velocity of 10m walking test (10MWT) according to the video	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10m walking test	Step width, step size, step frequency of 10m walking test (10MWT) according to the video	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	12 weeks
Dual-task walking	Pace, step width, step size, step frequency, dual task cost of dual-task walking (DTW) according to the video	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.)	12 weeks
Mini-mental state examination (MMSE)	Cognition evaluation according to Mini-mental state examination (Full score: 30. score <24 indicates cognitive impairment. )	12 weeks
Montreal cognitive assessment (MoCA)	Cognition evaluation according to Montreal cognitive assessment (Full score: 30. score <26 indicates cognitive impairment.	12 weeks
Symbol digit modalities test (SDMT)	Attention evaluation according to Symbol digit modalities test (Counting number of right modalities in 90s. )	12 weeks
Color word test (CWT)	Execution evaluation according to Color word test (Counting number of right ones. )	12 weeks
Hamilton depression scale (HAMD)	Mood evaluation according to Hamilton depression scale (Score >7 indicates possible depression.)	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. )	12 weeks

Collaborators and Investigators

• Sponsor: zsneurology
• Investigators: Principal Investigator: Xin Wang, MD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Gait Disorders, Neurologic; Neurologic Manifestations
• Other Study ID Numbers: 17411953800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No