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Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cerebellar Function Transcranial Magnetic Stimulation Language Disorders | Combination Product: Transcranial magnetic stimulation | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 106 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | A Prospective Randomized, Double-Blind Clinical Trial |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Through the Navigation Transcranial Magnetic Stimulation Over the Language Key Areas of Cerebellar to Enhance Language Function Recovery After Brain Tumor Resection |
| Actual Study Start Date : | October 30, 2018 |
| Estimated Primary Completion Date : | April 30, 2021 |
| Estimated Study Completion Date : | October 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: 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. |
Combination Product: Transcranial magnetic stimulation
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).
Other Name: speech rehabilitation training
|
|
Sham Comparator: 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.
|
Combination Product: Transcranial magnetic stimulation
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).
Other Name: speech rehabilitation training
|
- Boston naming test [ Time Frame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months ]The change of Boston naming test scores is being assessed
- MMSE [ Time Frame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months ]The change of Mini-mental State Examination scores is being assessed
- ABC [ Time Frame: 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
- ALFF [ Time Frame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months ]The change of Cerebellar spontaneous neurological activity level is being assessed
- Cerebellar gray matter volume [ Time Frame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months ]The change of Cerebellar gray matter volume is being assessed
- Functional connectivity of cerebellar network [ Time Frame: Change from postoperative 1 week to postoperative 1month & postoperative 3 months ]The change of functional connectivity of cerebellar network is being assessed
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
| Contact: Jinsong Wu, MD | 86-021-52887200 | wjsongc@126.com | |
| Contact: Tianming Qiu, MD | 86-021-52887200 | Tianming2100@126.com |
| China, Shanghai | |
| Huashan Hospital Affiliated to Fudan University | Recruiting |
| Shanghai, Shanghai, China, 200040 | |
| Contact: Jinsong Wu, MD 86-021-52887200 wjsongc@126.com | |
| Contact: Tianming Qiu, MD 86-021-52887200 Tianming2100@126.com | |
| Principal Investigator: Jinsong Wu, MD | |
| Sub-Investigator: Dongxiao Zhuang, MD | |
| Sub-Investigator: Tianming Qiu, MD | |
| Sub-Investigator: ruiping Hu, MD | |
| Sub-Investigator: Jie Zhang, MD | |
| Sub-Investigator: Qiao Shan, MD | |
| Sub-Investigator: Chengxin Ma, MD | |
| Shanghai Jing'an Central Hospital | Recruiting |
| Shanghai, Shanghai, China, 200040 | |
| Contact: Qingyang Luo, MD 021-61578000 luoqingyang529@sina.com | |
| Principal Investigator: | Jinsong Wu, MD | Huashan Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 20, 2019 | ||||||||
| First Posted Date ICMJE | June 5, 2019 | ||||||||
| Last Update Posted Date | June 5, 2019 | ||||||||
| Actual Study Start Date ICMJE | October 30, 2018 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients | ||||||||
| Official Title ICMJE | Through the Navigation Transcranial Magnetic Stimulation Over the Language Key Areas of Cerebellar to Enhance Language Function Recovery After Brain Tumor Resection | ||||||||
| Brief Summary |
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 |
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| Detailed Description |
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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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: A Prospective Randomized, Double-Blind Clinical Trial Masking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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| Condition ICMJE |
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||||||||
| Intervention ICMJE | Combination Product: Transcranial magnetic stimulation
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).
Other Name: speech rehabilitation training
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
106 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | October 30, 2021 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03974659 | ||||||||
| Other Study ID Numbers ICMJE | KY2018-395 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Jinsong Wu, Huashan Hospital | ||||||||
| Study Sponsor ICMJE | Huashan Hospital | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Huashan Hospital | ||||||||
| Verification Date | October 2018 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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