Effects of rTMS on Brain Alterations in Stroke Patients

• ClinicalTrials.gov Identifier: NCT03529305
• Recruitment Status: Unknown
• First Posted: May 18, 2018
• Last Update Posted: August 7, 2019
• Sponsor: Hangzhou Normal University
• Information provided by (Responsible Party): Yating Lv, PhD, Hangzhou Normal University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Device: rTMS; Other: Physical therapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Effects of Different Frequency rTMS on Brain Functional and Structural Alterations in Stroke Patient: Multi-modal MRI Study
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: rTMS; Receive rTMS treatment to the primary motor cortex (M1); Other: Physical therapy; Receive physical therapy
Experimental: 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.	Device: rTMS; Receive rTMS treatment to the primary motor cortex (M1); Other: Physical therapy; Receive physical therapy
Active Comparator: Physical therapy; Patients receive physical therapy for two weeks.	Other: Physical therapy; Receive physical therapy

Outcome Measures

Primary Outcome Measures :

1. Brain functional changes after rTMS treatment [ Time Frame: One day before and after two weeks' treatment ]
   Brain functional changes in patients' brain measured by fMRI
2. Brain morphological changes after rTMS treatment [ Time Frame: One day before and after two weeks' treatment ]
   Gray matter morphological changes in patients' brain measured by high resolution T1-weighted MRI
3. Brain structural changes after rTMS treatment [ Time Frame: One day before and after two weeks' treatment ]
   White matter anatomical changes in patients' brain measured by DTI

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Yating Lv, PhD; +86-13396508848; lvyating198247@gmail.com

Contact: Lingyu Li, Bachelor; +86-15990149749; llyxl621@126.com

Locations

China, Jiangsu

Affiliated Hospital of Nanjing University of Chinese Medicine; Recruiting

Nanjing, Jiangsu, China, 210000

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

China, Zhejiang

Hangzhou Normal University; Active, not recruiting

Hangzhou, Zhejiang, China, 311121

Sponsors and Collaborators

Hangzhou Normal University

Investigators

• Principal Investigator: Yu-Feng Zang, MD; Hangzhou Normal University

More Information

• Responsible Party: Yating Lv, PhD, Associate Investigator, Hangzhou Normal University
• ClinicalTrials.gov Identifier: NCT03529305
• Other Study ID Numbers: 2017YFC1310002
• First Posted: May 18, 2018
• Last Update Posted: August 7, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yating Lv, PhD, Hangzhou Normal University:

Stroke; rTMS; MRI

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases