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

Primary Purpose

Cerebellar Function, Transcranial Magnetic Stimulation, Language Disorders

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebellar Function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Huashan Hospital Affiliated to Fudan UniversityRecruiting
  • Shanghai Jing'an Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Theta Burst Stimulation

sham Theta Burst Stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Boston naming test
The change of Boston naming test scores is being assessed
MMSE
The change of Mini-mental State Examination scores is being assessed
ABC
Aphasia Battery of Chinese,Conclude naming, repeating, comprehend and spontaneous speech test,The change of ABC scores is being assessed
ALFF
The change of Cerebellar spontaneous neurological activity level is being assessed
Cerebellar gray matter volume
The change of Cerebellar gray matter volume is being assessed
Functional connectivity of cerebellar network
The change of functional connectivity of cerebellar network is being assessed

Secondary Outcome Measures

Full Information

First Posted
May 20, 2019
Last Updated
June 2, 2019
Sponsor
Huashan Hospital
Collaborators
Shanghai Jing'an Central Hospital, Huashan Hospital North Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03974659
Brief Title
Enhanced Recovery After Surgery Using TMS on Cerebellar Language Area for Brain Tumor Patients
Official Title
Through the Navigation Transcranial Magnetic Stimulation Over the Language Key Areas of Cerebellar to Enhance Language Function Recovery After Brain Tumor Resection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
Collaborators
Shanghai Jing'an Central Hospital, Huashan Hospital North Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Function, Transcranial Magnetic Stimulation, Language Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Prospective Randomized, Double-Blind Clinical Trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Theta Burst Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sham Theta Burst Stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Transcranial magnetic stimulation
Other Intervention Name(s)
speech rehabilitation training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Boston naming test
Description
The change of Boston naming test scores is being assessed
Time Frame
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Title
MMSE
Description
The change of Mini-mental State Examination scores is being assessed
Time Frame
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Title
ABC
Description
Aphasia Battery of Chinese,Conclude naming, repeating, comprehend and spontaneous speech test,The change of ABC scores is being assessed
Time Frame
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Title
ALFF
Description
The change of Cerebellar spontaneous neurological activity level is being assessed
Time Frame
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Title
Cerebellar gray matter volume
Description
The change of Cerebellar gray matter volume is being assessed
Time Frame
Change from postoperative 1 week to postoperative 1month & postoperative 3 months
Title
Functional connectivity of cerebellar network
Description
The change of functional connectivity of cerebellar network is being assessed
Time Frame
Change from postoperative 1 week to postoperative 1month & postoperative 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinsong Wu, MD
Phone
86-021-52887200
Email
wjsongc@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tianming Qiu, MD
Phone
86-021-52887200
Email
Tianming2100@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinsong Wu, MD
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinsong Wu, MD
Phone
86-021-52887200
Email
wjsongc@126.com
First Name & Middle Initial & Last Name & Degree
Tianming Qiu, MD
Phone
86-021-52887200
Email
Tianming2100@126.com
First Name & Middle Initial & Last Name & Degree
Jinsong Wu, MD
First Name & Middle Initial & Last Name & Degree
Dongxiao Zhuang, MD
First Name & Middle Initial & Last Name & Degree
Tianming Qiu, MD
First Name & Middle Initial & Last Name & Degree
ruiping Hu, MD
First Name & Middle Initial & Last Name & Degree
Jie Zhang, MD
First Name & Middle Initial & Last Name & Degree
Qiao Shan, MD
First Name & Middle Initial & Last Name & Degree
Chengxin Ma, MD
Facility Name
Shanghai Jing'an Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyang Luo, MD
Phone
021-61578000
Email
luoqingyang529@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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