Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients
Through the Navigation Transcranial Magnetic Stimulation Over the Language Key Areas of Cerebellar to Enhance Language Function Recovery After Brain Tumor Resection
At present, the incidence of language dysfunction in patients with brain language area tumor in the first month after operation was 20%-40%. The investigator's team has confirmed and found that bilateral cerebellar VIIa lobules are the critical areas of cerebellar which is closely related to the language function of the patients. This study aims at enhancing language function recovery after surgery through the transcranial magnetic stimulation stimulates the key areas of cerebellar.
This study is a prospective, randomized, double-blind, multi-center clinical trial in which participants with postoperative aphasia in the brain-language region tumors of three neurosurgery departments, Huashan Hospital, Shanghai Jing'an Center Hospital and Huashan Hospital North Hospital. Participants were randomly divided into Intervention group and control group. Before transcranial magnetic stimulation treatment, the two groups were required to conduct language behavior assessment and magnetic resonance imaging data. Participants in both groups were given 10 consecutive days bilateral cerebellar VIIa lobules Theta Burst Stimulation from one week after surgery and received speech rehabilitation training after stimulation.
The investigators collect patients MRI data and language behavioral assessment scores at 1week post operation and 1 month after the operation and 3 months after the operation. Subsequently, three MRI data and language behavioral assessment scores were processed and statistically analyzed to compare the differences between the two groups
연구 개요
상세 설명
Intervention group: Intermittent Theta Burst Stimulation(Positive stimulation) is used in right cerebellar VIIa lobule. Continuous Theta Burst Stimulation(Negative stimulation) is used in left cerebellar VIIa lobule. The stimulation intensity was 80% Rest Motor Threshold.According to the patients' condition, age and tolerance,the intensity should be adjusted.
Control group: The investigators use with fake stimulation , the appearance is the same as the magnetic stimulator used in the experimental group, and the stimulation will also make sounds, but no magnetic field effect, the stimulation mode is the same as the intervention group.
Subsequently, The investigators collect patients MRI data and language behavioral assessment scores at 1week post operation and 1 month after the operation and 3 months after the operation.three times MRI data and language behavioral assessment scores were processed and statistically analyzed to compare the differences between the two groups from the cerebellar spontaneous neurological activity level (ALFF), cerebellar gray matter volume, functional connectivity of cerebellar network and language behavioral score.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Shanghai
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Shanghai, Shanghai, 중국, 200040
- 모병
- Huashan Hospital Affiliated to Fudan University
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연락하다:
- Jinsong Wu, MD
- 전화번호: 86-021-52887200
- 이메일: wjsongc@126.com
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수석 연구원:
- Jinsong Wu, MD
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부수사관:
- Dongxiao Zhuang, MD
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부수사관:
- Tianming Qiu, MD
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부수사관:
- Jie Zhang, MD
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연락하다:
- Tianming Qiu, MD
- 전화번호: 86-021-52887200
- 이메일: Tianming2100@126.com
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부수사관:
- ruiping Hu, MD
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부수사관:
- Qiao Shan, MD
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부수사관:
- Chengxin Ma, MD
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Shanghai, Shanghai, 중국, 200040
- 모병
- Shanghai Jing'an Central Hospital
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연락하다:
- Qingyang Luo, MD
- 전화번호: 021-61578000
- 이메일: luoqingyang529@sina.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Language dysfunction after brain tumor surgery (aphasia quotient,AQ)< 93.8
- Chinese mother tongue
- Right handedness confirmed by Edinburgh Handedness Scale
- Tumor patients with linguistic region involvement in the dominant hemisphere
- Karnofsky Performance Status (KPS)< 70
- Voluntary participation in this project
Exclusion Criteria:
- Patients with frequent epileptic seizures (> 2 epilepsy episodes per week)
- Previous implants of metal pacemakers, stimulators, hearing aids, dentures, and insulin pumps or claustrophobia
- People with a history of psychiatric disorders
- Patients with severe medical diseases
- Patients with Alzheimer's disease and Parkinson's disease. Medical diseases
- Pregnant women
- Other clinical trials in the same period.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Theta Burst Stimulation
Intervention group: ten consecutive days bilateral cerebellar VIIa lobules Theta Burst Stimulation. Intermittent Theta Burst Stimulation(Positive stimulation) is used in right cerebellar VIIa lobule.Each stimulus had three 50 Hz monopulses, which were repeated every 200 ms. Each stimulation continued for 2 seconds and rested for 8 seconds. The total intervention time was 200s (600 pulses) Continuous Theta Burst Stimulation(Negative stimulation) is used in left cerebellar VIIa lobule,three 50 Hz monopulses in each stimulus, each with an interval of 200 ms, and each intervention lasted 40s (600 pulses). The stimulation intensity was 80% Rest Motor Threshold.According to the patients' condition, age and tolerance,the intensity should be adjusted. |
1.Patients were given 10 consecutive days bilateral cerebellar VIIa lobules Theta Burst Stimulation which was a special mode of Transcranial magnetic stimulation from one week after surgery Intermittent Theta Burst Stimulation(Positive stimulation) is used in right cerebellar VIIa lobule.Each stimulus had three 50 Hz monopulses, which were repeated every 200 ms.
Each stimulation continued for 2 seconds and rested for 8 seconds.
The total intervention time was 200s (600 pulses) Continuous Theta Burst Stimulation(Negative stimulation) is used in left cerebellar VIIa lobule,three 50 Hz monopulses in each stimulus, each with an interval of 200 ms, and each intervention lasted 40s (600 pulses).
다른 이름들:
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가짜 비교기: sham Theta Burst Stimulation
sham group: we flip coil to make fake stimulation, the stimulation will also make sounds, but no magnetic field effect, the stimulation mode is the same as the intervention group.
|
1.Patients were given 10 consecutive days bilateral cerebellar VIIa lobules Theta Burst Stimulation which was a special mode of Transcranial magnetic stimulation from one week after surgery Intermittent Theta Burst Stimulation(Positive stimulation) is used in right cerebellar VIIa lobule.Each stimulus had three 50 Hz monopulses, which were repeated every 200 ms.
Each stimulation continued for 2 seconds and rested for 8 seconds.
The total intervention time was 200s (600 pulses) Continuous Theta Burst Stimulation(Negative stimulation) is used in left cerebellar VIIa lobule,three 50 Hz monopulses in each stimulus, each with an interval of 200 ms, and each intervention lasted 40s (600 pulses).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Boston naming test
기간: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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The change of Boston naming test scores is being assessed
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Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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MMSE
기간: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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The change of Mini-mental State Examination scores is being assessed
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Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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ABC
기간: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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Aphasia Battery of Chinese，Conclude naming, repeating, comprehend and spontaneous speech test，The change of ABC scores is being assessed
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Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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ALFF
기간: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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The change of Cerebellar spontaneous neurological activity level is being assessed
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Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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Cerebellar gray matter volume
기간: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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The change of Cerebellar gray matter volume is being assessed
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Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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Functional connectivity of cerebellar network
기간: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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The change of functional connectivity of cerebellar network is being assessed
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Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Jinsong Wu, MD, Huashan Hospital
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
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