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

Glioma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05788445
• Other study ID #: No. 82203170
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: May 2025

Study information

• Verified date: March 2023
• Source: Beijing Neurosurgical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Glioma
• Non-fluent Aphasia

Intervention

Device:
• nrTMS treatment
Using the nrTMS treatment coli to stimulation with high frequency
• nrTMS sham
Using the nrTMS sham coli to stimulation with high frequency

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of language function	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	language recvoery	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