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Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients

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ClinicalTrials.gov Identifier: NCT03974659
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborators:
Shanghai Jing'an Central Hospital
Huashan Hospital North Hospital
Information provided by (Responsible Party):
Jinsong Wu, Huashan Hospital

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


Condition or disease Intervention/treatment Phase
Cerebellar Function Transcranial Magnetic Stimulation Language Disorders Combination Product: Transcranial magnetic stimulation Not Applicable

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 : 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974659


Contacts
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Contact: Jinsong Wu, MD 86-021-52887200 wjsongc@126.com
Contact: Tianming Qiu, MD 86-021-52887200 Tianming2100@126.com

Locations
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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   
Sponsors and Collaborators
Huashan Hospital
Shanghai Jing'an Central Hospital
Huashan Hospital North Hospital
Investigators
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Principal Investigator: Jinsong Wu, MD Huashan Hospital

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Responsible Party: Jinsong Wu, Principal Investigator, Clinical Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT03974659     History of Changes
Other Study ID Numbers: KY2018-395
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Brain Neoplasms
Language Disorders
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms