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Trial Title:
High-frequency nrTMS on the Contralateral Broca Mirror Area for Glioma Patients With Early Postoperative Aphasia
NCT ID:
NCT05788445
Condition:
Non-fluent Aphasia
Glioma
Conditions: Official terms:
Glioma
Aphasia
Aphasia, Broca
Conditions: Keywords:
human
language recovery
neuronavigated repetitive transcranial magnetic stimulation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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.
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, 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:
Intervention type:
Device
Intervention name:
nrTMS treatment
Description:
Using the nrTMS treatment coli to stimulation with high frequency
Arm group label:
nrTMS treatment
Intervention type:
Device
Intervention name:
nrTMS sham
Description:
Using the nrTMS sham coli to stimulation with high frequency
Arm group label:
nrTMS sham
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
April 2023
Completion date:
May 2025
Lead sponsor:
Agency:
Beijing Neurosurgical Institute
Agency class:
Other
Source:
Beijing Neurosurgical Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05788445
