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StrokeNCT03529305

Effects of rTMS on Brain Alterations in Stroke Patients

A study testing rTMS and Physical therapy in people with Stroke, run by Hangzhou Normal University at 2 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 The sponsor has not verified this record for over two years, so it may be out of date.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

In this study, the investigators aim to evaluate functional and structural improvements in the brain of stroke patients after rTMS treatment using multi-modal MRI techniques. Specifically, the investigators sought to determine whether rTMS treatment modulate the brain function and structure in patients and, if so… Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Stroke
What is being tested?
rTMS and Physical therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesChina
Study dates
1 Jan 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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • First-ever ischemic stroke
  • One to six months after stroke onset;
  • Mini Mental State Examination (MMSE) score > 24;
  • Brunnstrom recovery stage (BRS) for hand fingers of 3-5
  • Motor deficits of the unilateral upper limb

Who cannot join

  • Patients with hemorrhage, leukoaraiosis, epilepsy, migraine or psychiatric diseases history are excluded in this study.

Trial locations and contacts

2 sites in 1 country.

Lingyu Li, Bachelor contact

+86-15990149749

llyxl621@126.com

China2 sites, 1 recruiting
  • Hangzhou Normal University

    Hangzhou, Zhejiang, 311121

    Active, not recruiting
  • Affiliated Hospital of Nanjing University of Chinese Medicine

    Nanjing, Jiangsu, 210000

    Haiyang Fu, Master, +86-13851905128, fhy112@sina.com

    Recruiting

Other trials in China

About this study

Official title: Effects of Different Frequency rTMS on Brain Functional and Structural Alterations in Stroke Patient: Multi-modal MRI Study

In this study, the investigators aim to evaluate functional and structural improvements in the brain of stroke patients after rTMS treatment using multi-modal MRI techniques. Specifically, the investigators sought to determine whether rTMS treatment modulate the brain function and structure in patients and, if so, whether different frequency of the rTMS treatment will affect the degree of the motor recovery in patients' brain.

The patients will be randomized into three groups: Experimental group 1 (TMS group) received low frequency rTMS; Experimental group 2 (TMS group) received high frequency rTMS; The third group who received only physical therapy constituted the control group. All patients undergo MRI scan one day before and after rTMS treatment.

Read the detailed description

As the second leading cause of death and major cause of disability in the world, stroke is the rapid loss of brain function due to disturbance in the blood supply to the brain. Approximately two thirds of patients with stroke have impaired motor function even at three to six months after stroke onset. The abnormally increased interhemispheric inhibition driven from the unaffected to the affected hemisphere is associated with the motor impairment, which is characterized by increased cortical excitability in the unaffected hemisphere and decreased cortical excitability in the affected hemisphere. Rebalancing the cortical excitability between two hemispheres is associated with a better overall prognosis.

Repetitive transcranial magnetic stimulation (rTMS) is a painless, noninvasive brain stimulation technique. High-frequency rTMS facilitates cortical excitability, whereas low-frequency rTMS decreases the cortical excitability of the stimulated hemisphere. Therefore, rTMS can be used to increase and decrease the cortical excitability of the affected and unaffected hemispheres, respectively, and may facilitate motor function after stroke. However, the previous studies commonly applied behavioral scales to evaluate the effect of the rTMS treatment, little is known how the brain function and structure recover after rTMS treatment and whether the different frequency of rTMS will affect the recovery in the brain of stroke patients.

Non-invasive neuroimaging techniques provide promising avenues to detect brain function and structure in patients after stroke onset and have been increasingly applied to this disease. The morphology of the brain (cortical thickness, gray matter volume) is commonly assessed using T1-weighted MRI (Structural MRI). Diffusion tensor imaging (DTI) is a promising technique to study human brain structure, especially white matter anatomy, by providing multiple quantitative parameters to characterize tissue microstructure from different aspects. Functional magnetic resonance imaging (fMRI) is a functional neuroimaging technique which measures the changes of the blood oxygenation level-dependent (BOLD) signal that are highly correlated with neural activities. Task fMRI which applies stimulus-response pattern to identify the regions activated by performance of a cognitive task, while resting-state fMRI (rs-fMRI) is a promising tool to map intrinsic function of the human brain, which has unique advantages in clinical conditions because it does not require participants to engage in cognitive activities.

In this study, the investigators aim to evaluate functional and structural improvements in the brain of stroke patients after rTMS treatment using multi-modal MRI techniques. Specifically, the investigators sought to determine whether rTMS treatment modulate the brain function and structure in stroke patients and, if so, whether different frequency of the rTMS treatment will affect the degree of the motor recovery in patients' brain.

Conditions
Stroke
Being tested
rTMS, Physical therapy
Keywords
Stroke, rTMS, MRI
Medical subject headings
Stroke

What participants receive

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

  • rTMSDevice

    Receive rTMS treatment to the primary motor cortex (M1)

  • Physical therapyOther

    Receive physical therapy

Study groups in NCT03529305
Study groupRoleWhat they receive
Low frequency rTMSExperimentalPatients receive low frequency rTMS treatment and physical therapy. rTMS is applied over primary motor (M1) cortex of the unaffected side for two weeks, 5 consecutive days each week.
Receives: Device: rTMS; Other: Physical therapy
High frequency rTMSExperimentalPatients receive high frequency rTMS treatment and physical therapy. rTMS is applied over primary motor (M1) cortex of the affected side for two weeks, 5 consecutive days each week.
Receives: Device: rTMS; Other: Physical therapy
Physical therapyActive comparatorPatients receive physical therapy for two weeks.
Receives: Other: Physical therapy

What is being measured

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

  1. Brain functional changes after rTMS treatment

    Brain functional changes in patients' brain measured by fMRI

    Measured: One day before and after two weeks' treatment

  2. Brain morphological changes after rTMS treatment

    Gray matter morphological changes in patients' brain measured by high resolution T1-weighted MRI

    Measured: One day before and after two weeks' treatment

  3. Brain structural changes after rTMS treatment

    White matter anatomical changes in patients' brain measured by DTI

    Measured: One day before and after two weeks' treatment

Timeline

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

  1. First posted18 May 2018
  2. Study start1 Jan 2018
  3. Primary completion31 Dec 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, Care provider
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03529305
Sponsor's protocol ID
2017YFC1310002
Status last verified
Aug 2019
First submitted
19 Apr 2018
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing rTMS and Physical therapy in people with Stroke, run by Hangzhou Normal University at 2 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 5 inclusion and 1 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 Yating Lv, PhD (+86-13396508848, lvyating198247@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain functional changes after rTMS treatment (time frame: One day before and after two weeks' treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Aug 2019.

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