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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282538
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
zsneurology, Shanghai Zhongshan Hospital

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.

Condition or disease Intervention/treatment Phase
Repetitive Transcranial Magnetic Stimulation Transcranial Direct Current Stimulation Cerebrovascular Disease Gait Dysfunction, Neurologic Device: Active rTMS Device: Sham rTMS Device: Active tDCS Device: Sham tDCS Other: Walking training Other: Cognition training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation as Adjunctive Rehabilitation for Cerebrovascular Disease-related Gait Dysfunction
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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
Device: Sham rTMS
4-week (5 days per week) sham rTMS

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

Active Comparator: Group B - Active
Active tDCS for Frontal Gait Dysfunction
Device: Active tDCS
4-week (5 days per week) active tDCS (2mA, DLPFC, 20 min)

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

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

Sham Comparator: Group B - Sham
Sham tDCS for Frontal Gait Dysfunction
Device: Sham tDCS
4-week (5 days per week) sham tDCS

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

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




Primary Outcome Measures :
  1. Velocity of 10m walking test [ Time Frame: 12 weeks ]
    Velocity of 10m walking test (10MWT) according to the video


Secondary Outcome Measures :
  1. 10m walking test [ Time Frame: 12 weeks ]
    Step width, step size, step frequency of 10m walking test (10MWT) according to the video

  2. Turn time of time up and go test [ Time Frame: 12 weeks ]
    Total time, pace, standing time, turn time of time up and go test (TUGT) according to the video

  3. Dual-task walking [ Time Frame: 12 weeks ]
    Pace, step width, step size, step frequency, dual task cost of dual-task walking (DTW) according to the video

  4. Tinetti Balance and Gait Analysis [ Time Frame: 12 weeks ]
    Gait evaluation according to Tinetti Balance and Gait Analysis (Full score: 28. score >= 19 indicates high risk of fall.)

  5. Mini-mental state examination (MMSE) [ Time Frame: 12 weeks ]
    Cognition evaluation according to Mini-mental state examination (Full score: 30. score <24 indicates cognitive impairment. )

  6. Montreal cognitive assessment (MoCA) [ Time Frame: 12 weeks ]
    Cognition evaluation according to Montreal cognitive assessment (Full score: 30. score <26 indicates cognitive impairment.

  7. Symbol digit modalities test (SDMT) [ Time Frame: 12 weeks ]
    Attention evaluation according to Symbol digit modalities test (Counting number of right modalities in 90s. )

  8. Color word test (CWT) [ Time Frame: 12 weeks ]
    Execution evaluation according to Color word test (Counting number of right ones. )

  9. Hamilton depression scale (HAMD) [ Time Frame: 12 weeks ]
    Mood evaluation according to Hamilton depression scale (Score >7 indicates possible depression.)

  10. Instrumental activities of daily living (IADL) [ Time Frame: 12 weeks ]
    Daily living ability evaluation according to Instrumental activities of daily living (Full score: 24. Higher score indicates higher independence. )



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282538


Contacts
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Contact: Xin Wang, MD 02164041991 wang.xin@zs-hospital.sh.cn
Contact: Jing Ding, MD 02164041991 ding.jing@zs-hospital.sh.cn

Locations
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China, Shanghai
Shanghai Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: XIn Wang, MD         
Shanghai Eighth People's Hospital Recruiting
Shanghai, Shanghai, China
Contact: Jie Shen, MD         
Shanghai Huadong Hospital Recruiting
Shanghai, Shanghai, China
Contact: JieJiao Zheng, MD         
Shanghai Sixth People's Hospital Recruiting
Shanghai, Shanghai, China
Contact: YuWu Zhao, MD         
Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China
Contact: Xueyuan Liu, MD         
Shanghai Xuhui District Central Hospital Recruiting
Shanghai, Shanghai, China
Contact: Jian Yang, MD         
Sponsors and Collaborators
zsneurology
Investigators
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Principal Investigator: Xin Wang, MD Shanghai Zhongshan Hospital
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Responsible Party: zsneurology, Medical doctor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04282538    
Other Study ID Numbers: 17411953800
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Gait Disorders, Neurologic
Neurologic Manifestations
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms