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

Study Overview

• Status: Unknown
• Conditions: Transcranial Magnetic Stimulation; Language Disorders; Cerebellar Function
• Intervention / Treatment: Combination product: Transcranial magnetic stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinsong Wu, MD; Phone Number: 86-021-52887200; Email: wjsongc@126.com
• Study Contact Backup: Name: Tianming Qiu, MD; Phone Number: 86-021-52887200; Email: Tianming2100@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital affiliated to Fudan University
      • Contact: Jinsong Wu, MD; Phone Number: 86-021-52887200; Email: wjsongc@126.com
      • Principal Investigator: Jinsong Wu, MD
      • Sub-Investigator: Dongxiao Zhuang, MD
      • Sub-Investigator: Tianming Qiu, MD
      • Sub-Investigator: Jie Zhang, MD
      • Contact: Tianming Qiu, MD; Phone Number: 86-021-52887200; Email: Tianming2100@126.com
      • Sub-Investigator: ruiping Hu, MD
      • Sub-Investigator: Qiao Shan, MD
      • Sub-Investigator: Chengxin Ma, MD
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Shanghai Jing'an Central Hospital
      • Contact: Qingyang Luo, MD; Phone Number: 021-61578000; Email: luoqingyang529@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: speech rehabilitation training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston naming test	The change of Boston naming test scores is being assessed	Change from postoperative 1 week to postoperative 1month & postoperative 3 months
MMSE	The change of Mini-mental State Examination scores is being assessed	Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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
ALFF	The change of Cerebellar spontaneous neurological activity level is being assessed	Change from postoperative 1 week to postoperative 1month & postoperative 3 months
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
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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Shanghai Jing'an Central Hospital; Huashan Hospital North Hospital
• Investigators: Principal Investigator: Jinsong Wu, MD, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: June 2, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 2, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Communication Disorders; Language Disorders
• Other Study ID Numbers: KY2018-395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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