High-frequency nrTMS on the Contralateral Broca Mirror Area for Glioma Patients With Early Postoperative Aphasia

Sponsor

Beijing Neurosurgical Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05788445

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this randomized clinical controlled trial is to determine whether the application of high frequency neuronavigated repetitive transcranial magnetic stimulation (nrTMS) on the contralateral of Broca's area can ameliorate glioma patients's non-fluent aphasia after tumor resection.

The questions this trial is aiming to answer are:

Whether the nrTMS can ameliorate glioma patients' postoperative language impairements.
if yes, how effective nrTMS is for improving glioma patients' postoperative language function.

Condition or Disease	Intervention/Treatment	Phase
Non-fluent Aphasia Glioma	Device: nrTMS treatment Device: nrTMS sham	N/A

Detailed Description

The including criteria:

Right-handed, age: 20~65 years old, tumor involves left language function area, no previous history of treatment of neurological diseases, and preoperative cognitive and language function assessment is normal B. Access to formal education at the primary level and above C. Postoperative pathology is primary low-grade glioma D. Language function assessed as motor aphasia on days 7-10 after surgery E. Willing to receive nrTMS rehabilitation F. The patient and family sign informed consent

The excluding criteria:

Tumor grows across the midline to the opposite side B. Undergoing unplanned surgery after the first tumor resection C. Patients request to withdraw from the study during treatment D. During the treatment period, the patient is unable to continue treatment due to force majeure
Patient loss or refusal of follow-up during the study F. Patients are considered by the investigator to be unsuitable for participation in this study

All patients will receive nrTMS treatment or nrTMS sham treatment for 7 sessions within 10 days (one session per day), start at the 7th - 10th day after glioma resection. The effects of nrTMS treatment will be determine by using the Western Aphasia Battery to evaluate patients' language function after each session and each follow-up interview (every 7-10 days after the whole treatment session finished until the end of the 3rd month after tumor resection or patients' language evaluation shows the language function recoveried to the normal level).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

There are two groups in this study. One group includes patients who receive nrTMS stimulation with high frequency on the contralateral Broca's area on the right hemisphere. The second group includes patients who receive nrTMS sham stimulation with high frequency on the contralateral Broca's area on the right hemishere.There are two groups in this study. One group includes patients who receive nrTMS stimulation with high frequency on the contralateral Broca's area on the right hemisphere. The second group includes patients who receive nrTMS sham stimulation with high frequency on the contralateral Broca's area on the right hemishere.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

There are two stimulating colis with the same shape, color and touch. The one is able to stimulate, the other is able to sham-stimulate. All patients are randomly assigned to use one of the two coils for treatment. Except for the designer, all participant, care provider, investigator, and outcomes assessorthey don not know who used which coil to treatment.

Primary Purpose:

Treatment

Official Title:

A Double-blind Randomized Controlled Clinical Trial of High-frequency nrTMS on the Contralateral Broca Mirror Area for Language Recovery in Patients With Non-fluent Aphasia After Glioma Surgery

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nrTMS treatment using nrTMS coli to stimulate the contralateral Broca's area on the right hemisphere with high freqency stimulation.	Device: nrTMS treatment Using the nrTMS treatment coli to stimulation with high frequency
Sham Comparator: nrTMS sham using nrTMS sham-coli to stimulate the contralateral Broca's area on the right hemisphere with high frequency stimulation.	Device: nrTMS sham Using the nrTMS sham coli to stimulation with high frequency

Arm

Intervention/Treatment

Experimental: nrTMS treatment

using nrTMS coli to stimulate the contralateral Broca's area on the right hemisphere with high freqency stimulation.

Device: nrTMS treatment

Using the nrTMS treatment coli to stimulation with high frequency

Sham Comparator: nrTMS sham

using nrTMS sham-coli to stimulate the contralateral Broca's area on the right hemisphere with high frequency stimulation.

Device: nrTMS sham

Using the nrTMS sham coli to stimulation with high frequency

Outcome Measures

Primary Outcome Measures

Improvement of language function [from the day of tumor resection to 3 months after tumor resection]
Based on the result of western aphasia battery, patients' language score incrased 200% of the score before the treatment started.

Secondary Outcome Measures

language recvoery [from the day of tumor resection to 3 months after tumor resection]
Based on the result of western aphasia battery, patients' language score increased above the cut off line for aphaisa that the language function can be identified as non-aphasia.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Right-handed, age: 20~65 years old, tumor involves left language function area, no previous history of treatment of neurological diseases, and preoperative cognitive and language function assessment is normal B. Access to formal education at the primary level and above C. Postoperative pathology is primary low-grade glioma D. Language function assessed as motor aphasia on days 7-10 after surgery E. Willing to receive nrTMS rehabilitation F. The patient and family sign informed consent

Exclusion Criteria:

Tumor grows across the midline to the opposite side B. Undergoing unplanned surgery after the first tumor resection C. Patients request to withdraw from the study during treatment D. During the treatment period, the patient is unable to continue treatment due to force majeure E. Patient loss or refusal of follow-up during the study F. Patients are considered by the investigator to be unsuitable for participation in this study