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

March 15, 2023 updated by: Beijing Neurosurgical Institute

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

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:

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The including criteria:

A. 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:

A. 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

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

A. 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:

A. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of language function
Time Frame: 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.
from the day of tumor resection to 3 months after tumor resection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
language recvoery
Time Frame: 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.
from the day of tumor resection to 3 months after tumor resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Neurosurgical Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. 82203170

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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