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

NCT05788445 | Unknown DMC

• 1 other identifier: No. 82203170
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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. 1.Whether the nrTMS can ameliorate glioma patients' postoperative language impairements.
2. 2.if yes, how effective nrTMS is for improving glioma patients' postoperative language function.

Conditions

Non-fluent Aphasia; Glioma

Keywords

human; language recovery; neuronavigated repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Improvement of language function

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

  from the day of tumor resection to 3 months after tumor resection

Secondary Outcomes (1)

• language recvoery

  from the day of tumor resection to 3 months after tumor resection

Study Arms (2)

nrTMS treatment

EXPERIMENTAL

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

Device: nrTMS treatment

nrTMS sham

SHAM COMPARATOR

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

Device: nrTMS sham

Interventions

nrTMS treatment DEVICE

Using the nrTMS treatment coli to stimulation with high frequency

nrTMS treatment

nrTMS sham DEVICE

Using the nrTMS sham coli to stimulation with high frequency

nrTMS sham

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Neurosurgical Institute: lead

MeSH Terms

Conditions

Aphasia, Broca; Glioma

Condition Hierarchy (Ancestors)

Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 28, 2023
• Study Start: April 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: March 28, 2023

Record last verified: 2023-03