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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

100

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach

1 country

6 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

December 1, 2018

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2019

Completed

7 months until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed

Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

July 25, 2019

Last Update Submit

February 21, 2020

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (10)

10m walking test
12 weeks
Turn time of time up and go test
12 weeks
Dual-task walking
12 weeks
Tinetti Balance and Gait Analysis
12 weeks
Mini-mental state examination (MMSE)
12 weeks
+5 more secondary outcomes

Study Arms (4)

Group A - Active

ACTIVE COMPARATOR

Active rTMS for Gait Dysfunction of Hemiplegia

Device: Active rTMSOther: Walking training

Group A - Sham

SHAM COMPARATOR

Sham rTMS for Gait Dysfunction of Hemiplegia

Device: Sham rTMSOther: Walking training

Group B - Active

ACTIVE COMPARATOR

Active tDCS for Frontal Gait Dysfunction

Device: Active tDCSOther: Walking trainingOther: Cognition training

Group B - Sham

SHAM COMPARATOR

Sham tDCS for Frontal Gait Dysfunction

Device: Sham tDCSOther: Walking trainingOther: Cognition training

Interventions

Active rTMSDEVICE

4-week (5 days per week) active rTMS (90%rMT, M1, 10Hz for 10s, 50s interval, 20 trains)

Group A - Active

Sham rTMSDEVICE

4-week (5 days per week) sham rTMS

Group A - Sham

Active tDCSDEVICE

4-week (5 days per week) active tDCS (2mA, DLPFC, 20 min)

Group B - Active

Sham tDCSDEVICE

4-week (5 days per week) sham tDCS

Group B - Sham

Walking trainingOTHER

4-week (5 days per week) walking training

Group A - ActiveGroup A - ShamGroup B - ActiveGroup B - Sham

Cognition trainingOTHER

4-week (5 days per week) cognition training

Group B - ActiveGroup B - Sham

Eligibility Criteria

Age35 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

zsneurologylead

Study Sites (6)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai Eighth People's Hospital