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Repetitive Transcranial Magnetic StimulationNCT04282538

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

A study testing Active rTMS, Active tDCS and Walking training in people with Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation, run by zsneurology at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 35 to 75 years
What is being tested?
Active rTMS, Active tDCS and Walking training
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
6 sitesChina
Study dates
1 Dec 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

Xin Wang, MD contact

02164041991

wang.xin@zs-hospital.sh.cn

Jing Ding, MD contact

02164041991

ding.jing@zs-hospital.sh.cn

6 sites in 1 country

China6 sites, 6 recruiting

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

    XIn Wang, MD

    Recruiting

  • Shanghai Eighth People's Hospital

    Shanghai, Shanghai Municipality

    Jie Shen, MD

    Recruiting

  • Shanghai Huadong Hospital

    Shanghai, Shanghai Municipality

    JieJiao Zheng, MD

    Recruiting

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality

    YuWu Zhao, MD

    Recruiting

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality

    Xueyuan Liu, MD

    Recruiting

  • Shanghai Xuhui District Central Hospital

    Shanghai, Shanghai Municipality

    Jian Yang, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Active rTMS, Sham rTMS, Active tDCS, Sham tDCS, Walking training
Medical subject headings
Cerebrovascular Disorders, Gait Disorders, Neurologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active rTMSDevice

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

  • Sham rTMSDevice

    4-week (5 days per week) sham rTMS

  • Active tDCSDevice

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

  • Sham tDCSDevice

    4-week (5 days per week) sham tDCS

  • Walking trainingOther

    4-week (5 days per week) walking training

  • Cognition trainingOther

    4-week (5 days per week) cognition training

Study groups in NCT04282538
Study groupRoleWhat they receive
Group A - ActiveActive comparatorActive rTMS for Gait Dysfunction of Hemiplegia
Receives: Device: Active rTMS; Other: Walking training
Group A - ShamSham comparatorSham rTMS for Gait Dysfunction of Hemiplegia
Receives: Device: Sham rTMS; Other: Walking training
Group B - ActiveActive comparatorActive tDCS for Frontal Gait Dysfunction
Receives: Device: Active tDCS; Other: Walking training; Other: Cognition training
Group B - ShamSham comparatorSham tDCS for Frontal Gait Dysfunction
Receives: Device: Sham tDCS; Other: Walking training; Other: Cognition training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Velocity of 10m walking test

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

    Measured: 12 weeks

Secondary outcomes (10)

  1. 10m walking test

    Step width, step size, step frequency of 10m walking test (10MWT) according to the video

    Measured: 12 weeks

  2. 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

    Measured: 12 weeks

  3. Dual-task walking

    Pace, step width, step size, step frequency, dual task cost of dual-task walking (DTW) according to the video

    Measured: 12 weeks

  4. Tinetti Balance and Gait Analysis

    Gait evaluation according to Tinetti Balance and Gait Analysis (Full score: 28. score >= 19 indicates high risk of fall.)

    Measured: 12 weeks

  5. Mini-mental state examination (MMSE)

    Cognition evaluation according to Mini-mental state examination (Full score: 30. score <24 indicates cognitive impairment. )

    Measured: 12 weeks

  6. Montreal cognitive assessment (MoCA)

    Cognition evaluation according to Montreal cognitive assessment (Full score: 30. score <26 indicates cognitive impairment.

    Measured: 12 weeks

  7. Symbol digit modalities test (SDMT)

    Attention evaluation according to Symbol digit modalities test (Counting number of right modalities in 90s. )

    Measured: 12 weeks

  8. Color word test (CWT)

    Execution evaluation according to Color word test (Counting number of right ones. )

    Measured: 12 weeks

  9. Hamilton depression scale (HAMD)

    Mood evaluation according to Hamilton depression scale (Score >7 indicates possible depression.)

    Measured: 12 weeks

  10. 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. )

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2020
  2. Study start1 Dec 2018
  3. Primary completion30 Nov 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04282538
Sponsor's protocol ID
17411953800
Status last verified
Feb 2020
First submitted
25 Jul 2019
Last updated
24 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active rTMS, Active tDCS and Walking training in people with Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation, run by zsneurology at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xin Wang, MD (02164041991, wang.xin@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Velocity of 10m walking test (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04282538.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.

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