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

Primary Purpose

Non-fluent Aphasia, Glioma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nrTMS treatment
nrTMS sham
Sponsored by
Beijing Neurosurgical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-fluent Aphasia focused on measuring human, language recovery, neuronavigated repetitive transcranial magnetic stimulation

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    nrTMS treatment

    nrTMS sham

    Arm Description

    using nrTMS coli to stimulate the contralateral Broca's area on the right hemisphere with high freqency stimulation.

    using nrTMS sham-coli to stimulate the contralateral Broca's area on the right hemisphere with high frequency stimulation.

    Outcomes

    Primary Outcome Measures

    Improvement of language function
    Based on the result of western aphasia battery, patients' language score incrased 200% of the score before the treatment started.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    March 15, 2023
    Sponsor
    Beijing Neurosurgical Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05788445
    Brief Title
    High-frequency nrTMS on the Contralateral Broca Mirror Area for Glioma Patients With Early Postoperative Aphasia
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Neurosurgical Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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: Whether the nrTMS can ameliorate glioma patients' postoperative language impairements. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-fluent Aphasia, Glioma
    Keywords
    human, language recovery, neuronavigated repetitive transcranial magnetic stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    nrTMS treatment
    Arm Type
    Experimental
    Arm Description
    using nrTMS coli to stimulate the contralateral Broca's area on the right hemisphere with high freqency stimulation.
    Arm Title
    nrTMS sham
    Arm Type
    Sham Comparator
    Arm Description
    using nrTMS sham-coli to stimulate the contralateral Broca's area on the right hemisphere with high frequency stimulation.
    Intervention Type
    Device
    Intervention Name(s)
    nrTMS treatment
    Intervention Description
    Using the nrTMS treatment coli to stimulation with high frequency
    Intervention Type
    Device
    Intervention Name(s)
    nrTMS sham
    Intervention Description
    Using the nrTMS sham coli to stimulation with high frequency
    Primary Outcome Measure Information:
    Title
    Improvement of language function
    Description
    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
    Secondary Outcome Measure Information:
    Title
    language recvoery
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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