Through the Navigation Transcranial Magnetic Stimulation Over the Language Key Areas of Cerebellar to Enhance Language Function Recovery After Brain Tumor Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Cerebellar gray matter volume
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Transcranial magnetic stimulation (Combination Product)
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.
干预措施: Transcranial magnetic stimulation (Combination Product)
结局指标
主要结局
Cerebellar gray matter volume
时间窗: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Cerebellar gray matter volume is being assessed
ABC
时间窗: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Aphasia Battery of Chinese，Conclude naming, repeating, comprehend and spontaneous speech test，The change of ABC scores is being assessed
Boston naming test
时间窗: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Boston naming test scores is being assessed
MMSE
时间窗: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Mini-mental State Examination scores is being assessed
ALFF
时间窗: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of Cerebellar spontaneous neurological activity level is being assessed
Functional connectivity of cerebellar network
时间窗: Change from postoperative 1 week to postoperative 1month & postoperative 3 months
The change of functional connectivity of cerebellar network is being assessed
次要结局
未报告次要终点
研究者
Jinsong Wu
Principal Investigator, Clinical Professor
Huashan Hospital