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
Status | Recruiting |
Enrollment | 106 |
Est. completion date | October 30, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai |
China | Shanghai Jing'an Central Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital | Huashan Hospital North Hospital, Shanghai Jing'an Central Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Boston naming test | The change of Boston naming test scores is being assessed | Change from postoperative 1 week to postoperative 1month & postoperative 3 months | |
Primary | MMSE | The change of Mini-mental State Examination scores is being assessed | Change from postoperative 1 week to postoperative 1month & postoperative 3 months | |
Primary | 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 | |
Primary | ALFF | The change of Cerebellar spontaneous neurological activity level is being assessed | Change from postoperative 1 week to postoperative 1month & postoperative 3 months | |
Primary | 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 | |
Primary | 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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