An interventional study of nrTMS treatment and nrTMS sham in Non-fluent Aphasia and Glioma, sponsored by Beijing Neurosurgical Institute. Not yet recruiting. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Beijing Neurosurgical Institute · Not applicable, Interventional, and Treatment
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:
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).
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's planned enrollment of 48 is above the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →Beijing Neurosurgical Institute is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
using nrTMS coli to stimulate the contralateral Broca's area on the right hemisphere with high freqency stimulation.
Device: nrTMS treatment
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 treatment coli to stimulation with high frequency
Using the nrTMS sham coli to stimulation with high frequency
Improvement of language function
Based on the result of western aphasia battery, patients' language score incrased 200% of the score before the treatment started.
Time frame: from the day of tumor resection to 3 months after tumor resection
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.
Time frame: from the day of tumor resection to 3 months after tumor resection
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Beijing Neurosurgical Institute