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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Shanghai
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Shanghai, Shanghai, Chiny, 200040
- Rekrutacyjny
- Huashan Hospital Affiliated to Fudan University
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Kontakt:
- Jinsong Wu, MD
- Numer telefonu: 86-021-52887200
- E-mail: wjsongc@126.com
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Główny śledczy:
- Jinsong Wu, MD
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Pod-śledczy:
- Dongxiao Zhuang, MD
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Pod-śledczy:
- Tianming Qiu, MD
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Pod-śledczy:
- Jie Zhang, MD
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Kontakt:
- Tianming Qiu, MD
- Numer telefonu: 86-021-52887200
- E-mail: Tianming2100@126.com
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Pod-śledczy:
- ruiping Hu, MD
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Pod-śledczy:
- Qiao Shan, MD
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Pod-śledczy:
- Chengxin Ma, MD
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Shanghai, Shanghai, Chiny, 200040
- Rekrutacyjny
- Shanghai Jing'an Central Hospital
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Kontakt:
- Qingyang Luo, MD
- Numer telefonu: 021-61578000
- E-mail: luoqingyang529@sina.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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).
Inne nazwy:
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Pozorny komparator: 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).
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Boston naming test
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Jinsong Wu, MD, Huashan Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- KY2018-395
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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