Glioma, Non-fluent Aphasia
Conditions
Keywords
human, language recovery, neuronavigated repetitive transcranial magnetic stimulation
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).
Interventions
DEVICEnrTMS treatment
Using the nrTMS treatment coli to stimulation with high frequency
DEVICEnrTMS sham
Using the nrTMS sham coli to stimulation with high frequency
Sponsors
Beijing Neurosurgical Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed