High-frequency nrTMS on the Contralateral Broca Mirror Area for Glioma Patients With Early Postoperative Aphasia
- Conditions
- GliomaNon-fluent Aphasia
- Interventions
- Device: nrTMS shamDevice: nrTMS treatment
- Registration Number
- NCT05788445
- Lead Sponsor
- Beijing Neurosurgical Institute
- 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:
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.
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 48
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description nrTMS sham nrTMS sham using nrTMS sham-coli to stimulate the contralateral Broca's area on the right hemisphere with high frequency stimulation. nrTMS treatment nrTMS treatment using nrTMS coli to stimulate the contralateral Broca's area on the right hemisphere with high freqency stimulation.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.