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

Primary Purpose

Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation, Cerebrovascular Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Active rTMS
Sham rTMS
Active tDCS
Sham tDCS
Walking training
Cognition training
Sponsored by
zsneurology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Zhongshan HospitalRecruiting
  • Shanghai Eighth People's HospitalRecruiting
  • Shanghai Huadong HospitalRecruiting
  • Shanghai Sixth People's HospitalRecruiting
  • Shanghai Tenth People's HospitalRecruiting
  • Shanghai Xuhui District Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

Group A - Active

Group A - Sham

Group B - Active

Group B - Sham

Arm Description

Active rTMS for Gait Dysfunction of Hemiplegia

Sham rTMS for Gait Dysfunction of Hemiplegia

Active tDCS for Frontal Gait Dysfunction

Sham tDCS for Frontal Gait Dysfunction

Outcomes

Primary Outcome Measures

Velocity of 10m walking test
Velocity of 10m walking test (10MWT) according to the video

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2019
Last Updated
February 21, 2020
Sponsor
zsneurology
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1. Study Identification

Unique Protocol Identification Number
NCT04282538
Brief Title
Efficacy of rTMS and tDCS as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction
Official Title
Efficacy of Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
zsneurology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation, Cerebrovascular Disease, Gait Dysfunction, Neurologic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A - Active
Arm Type
Active Comparator
Arm Description
Active rTMS for Gait Dysfunction of Hemiplegia
Arm Title
Group A - Sham
Arm Type
Sham Comparator
Arm Description
Sham rTMS for Gait Dysfunction of Hemiplegia
Arm Title
Group B - Active
Arm Type
Active Comparator
Arm Description
Active tDCS for Frontal Gait Dysfunction
Arm Title
Group B - Sham
Arm Type
Sham Comparator
Arm Description
Sham tDCS for Frontal Gait Dysfunction
Intervention Type
Device
Intervention Name(s)
Active rTMS
Intervention Description
4-week (5 days per week) active rTMS (90%rMT, M1, 10Hz for 10s, 50s interval, 20 trains)
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Intervention Description
4-week (5 days per week) sham rTMS
Intervention Type
Device
Intervention Name(s)
Active tDCS
Intervention Description
4-week (5 days per week) active tDCS (2mA, DLPFC, 20 min)
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
4-week (5 days per week) sham tDCS
Intervention Type
Other
Intervention Name(s)
Walking training
Intervention Description
4-week (5 days per week) walking training
Intervention Type
Other
Intervention Name(s)
Cognition training
Intervention Description
4-week (5 days per week) cognition training
Primary Outcome Measure Information:
Title
Velocity of 10m walking test
Description
Velocity of 10m walking test (10MWT) according to the video
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
10m walking test
Description
Step width, step size, step frequency of 10m walking test (10MWT) according to the video
Time Frame
12 weeks
Title
Turn time of time up and go test
Description
Total time, pace, standing time, turn time of time up and go test (TUGT) according to the video
Time Frame
12 weeks
Title
Dual-task walking
Description
Pace, step width, step size, step frequency, dual task cost of dual-task walking (DTW) according to the video
Time Frame
12 weeks
Title
Tinetti Balance and Gait Analysis
Description
Gait evaluation according to Tinetti Balance and Gait Analysis (Full score: 28. score >= 19 indicates high risk of fall.)
Time Frame
12 weeks
Title
Mini-mental state examination (MMSE)
Description
Cognition evaluation according to Mini-mental state examination (Full score: 30. score <24 indicates cognitive impairment. )
Time Frame
12 weeks
Title
Montreal cognitive assessment (MoCA)
Description
Cognition evaluation according to Montreal cognitive assessment (Full score: 30. score <26 indicates cognitive impairment.
Time Frame
12 weeks
Title
Symbol digit modalities test (SDMT)
Description
Attention evaluation according to Symbol digit modalities test (Counting number of right modalities in 90s. )
Time Frame
12 weeks
Title
Color word test (CWT)
Description
Execution evaluation according to Color word test (Counting number of right ones. )
Time Frame
12 weeks
Title
Hamilton depression scale (HAMD)
Description
Mood evaluation according to Hamilton depression scale (Score >7 indicates possible depression.)
Time Frame
12 weeks
Title
Instrumental activities of daily living (IADL)
Description
Daily living ability evaluation according to Instrumental activities of daily living (Full score: 24. Higher score indicates higher independence. )
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang, MD
Phone
02164041991
Email
wang.xin@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Ding, MD
Phone
02164041991
Email
ding.jing@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XIn Wang, MD
Facility Name
Shanghai Eighth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Shen, MD
Facility Name
Shanghai Huadong Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JieJiao Zheng, MD
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YuWu Zhao, MD
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueyuan Liu, MD
Facility Name
Shanghai Xuhui District Central Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Yang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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