Transcranial Magnetic Stimulation Clinical Trial
Official title:
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
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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