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| Name | Class |
|---|---|
| Shanghai Jing'an Central Hospital | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theta Burst Stimulation | Active Comparator | 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. |
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| sham Theta Burst Stimulation | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial magnetic stimulation | Combination Product | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Boston naming test | The change of Boston naming test scores is being assessed | Change from postoperative 1 week to postoperative 1month & postoperative 3 months |
| MMSE | The change of Mini-mental State Examination scores is being assessed | Change from postoperative 1 week to postoperative 1month & postoperative 3 months |
| ABC | Aphasia Battery of Chinese，Conclude naming, repeating, comprehend and spontaneous speech test，The change of ABC scores is being assessed | Change from postoperative 1 week to postoperative 1month & postoperative 3 months |
| ALFF | The change of Cerebellar spontaneous neurological activity level is being assessed | Change from postoperative 1 week to postoperative 1month & postoperative 3 months |
| Cerebellar gray matter volume | The change of Cerebellar gray matter volume is being assessed | Change from postoperative 1 week to postoperative 1month & postoperative 3 months |
| Functional connectivity of cerebellar network | The change of functional connectivity of cerebellar network is being assessed | Change from postoperative 1 week to postoperative 1month & postoperative 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinsong Wu, MD | Contact | 86-021-52887200 | wjsongc@126.com | |
| Tianming Qiu, MD | Contact | 86-021-52887200 | Tianming2100@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinsong Wu, MD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D007806 | Language Disorders |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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A Prospective Randomized, Double-Blind Clinical Trial
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| Shanghai Jing'an Central Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |