Effects of rTMS on Brain Alterations in Stroke Patients

NCT ID: NCT03529305

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-12-31

Brief 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, 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low frequency rTMS

Patients 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.

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

Receive rTMS treatment to the primary motor cortex (M1)

Physical therapy

Intervention Type: OTHER

Receive physical therapy

High frequency rTMS

Patients 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.

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

Receive rTMS treatment to the primary motor cortex (M1)

Physical therapy

Intervention Type: OTHER

Receive physical therapy

Physical therapy

Patients receive physical therapy for two weeks.

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: OTHER

Receive physical therapy

Interventions

rTMS

Receive rTMS treatment to the primary motor cortex (M1)

Intervention Type: DEVICE

Physical therapy

Receive physical therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. First-ever ischemic stroke

2. One to six months after stroke onset;

3. Mini Mental State Examination (MMSE) score > 24;

4. Brunnstrom recovery stage (BRS) for hand fingers of 3-5

5. Motor deficits of the unilateral upper limb

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Normal University

OTHER

Sponsor Role: lead

Responsible Party

Yating Lv, PhD

Associate Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu-Feng Zang, MD

Role: PRINCIPAL_INVESTIGATOR

Hangzhou Normal University

Locations

Affiliated Hospital of Nanjing University of Chinese Medicine

Nanjing, Jiangsu, China

Site Status: RECRUITING

Hangzhou Normal University

Hangzhou, Zhejiang, China

Site Status: ACTIVE_NOT_RECRUITING

Countries

China

Central Contacts

Yating Lv, PhD

Role: CONTACT

lvyating198247@gmail.com

+86-13396508848

Lingyu Li, Bachelor

Role: CONTACT

llyxl621@126.com

+86-15990149749

Facility Contacts

Haiyang Fu, Master

Role: primary

fhy112@sina.com

+86-13851905128

Other Identifiers

2017YFC1310002

Identifier Type: -

Identifier Source: org_study_id