- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03529305
Effects of rTMS on Brain Alterations in Stroke Patients
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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Jiangsu
-
Nanjing, Jiangsu, 중국, 210000
- 모병
- Affiliated Hospital of Nanjing University of Chinese Medicine
-
연락하다:
- Haiyang Fu, Master
- 전화번호: +86-13851905128
- 이메일: fhy112@sina.com
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 311121
- 모집하지 않고 적극적으로
- Hangzhou Normal University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
Patients with hemorrhage, leukoaraiosis, epilepsy, migraine or psychiatric diseases history are excluded in this study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
|
Receive rTMS treatment to the primary motor cortex (M1)
Receive physical therapy
|
실험적: 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.
|
Receive rTMS treatment to the primary motor cortex (M1)
Receive physical therapy
|
활성 비교기: Physical therapy
Patients receive physical therapy for two weeks.
|
Receive physical therapy
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Brain functional changes after rTMS treatment
기간: One day before and after two weeks' treatment
|
Brain functional changes in patients' brain measured by fMRI
|
One day before and after two weeks' treatment
|
Brain morphological changes after rTMS treatment
기간: One day before and after two weeks' treatment
|
Gray matter morphological changes in patients' brain measured by high resolution T1-weighted MRI
|
One day before and after two weeks' treatment
|
Brain structural changes after rTMS treatment
기간: One day before and after two weeks' treatment
|
White matter anatomical changes in patients' brain measured by DTI
|
One day before and after two weeks' treatment
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Yu-Feng Zang, MD, Hangzhou Normal University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
rTMS에 대한 임상 시험
-
Centre hospitalier de Ville-Evrard, France모병
-
Changping LaboratoryBeijing HuiLongGuan Hospital모병
-
National Taiwan University Hospital Hsin-Chu Branch아직 모집하지 않음
-
University of TehranStanford University완전한