Accelerating Motor Recovering in Patients With SMA Syndrome After Glioma Surgery by Using nrTMS

Beijing Neurosurgical Institute

Status: Enrolling

Conditions: Glioma; Supplementary Motor Area Syndrome; Motor Cortex; Lesion

Treatments: Device: TMS stimulation sham-treatment; Device: TMS stimulation treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05803057

8220101798

Details and patient eligibility

About

The goal of this randomized clinical controlled trial is to learn about whether neuro-navigation repetitive transcranial magnetic stimulation (nrTMS) was useful to accelerate the recovery in patients with SMA syndrome after glioma resection. The main questions aim to answer:

• Question 1: Whether the nrTMS was useful to accelerate the recovery of motor function back to the preoperative status in participants with SMA syndrome after glioma resection.
• Question 2: Whether the nrTMS was useful to improve postoperative motor function in participants with SMA syndrome after glioma resection.

Participants will continue to receive nrTMS treatment or nrTMS sham-treatment for 7 times on the 8th day after glioma resection to determine whether the TMS was helpful for exercise rehabilitation. The investigator will evaluate the effects of nrTMS treatment through the ratio of recovery of motor function and the time that was from the participants suffering SMA syndrome to totally recover the motor function to the status of motor function in pre-operation.

Full description

This study will use the 8-coil (Magstem, England, No.4150) and sham 8-coil (Magstem, England) The criteria of enrolled patients are： A. Inclusion time: from April 01 2023 to March 31 2025 (including the current month); B. Inpatients in neurosurgery oncology wards of Beijing Tiantan Hospital; C. Right-handed, age: 25-55 years old, tumor located in SMA, no previous treatment history of nervous system disease; D. The patient received wake-up surgery and applied direct cortical electrical stimulation during the operation to determine the location of the motor area; E. Postoperative pathology was low grade glioma; F. Can accept nrTMS rehabilitation treatment.

The excluding criteria are:

A. The tumor grows across the midline to the opposite side; B. When collecting rs-fMRI data, head movement exceeds 1mm and head deflection exceeds 1 °; C. The patient did not have SMA syndrome after operation; D. Vulnerable or special groups and protective measures, such as pregnant women.

Enrollment: 64 estimated patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inpatients in neurosurgery oncology wards of Beijing Tiantan Hospital
• Right-handed, age: 25-55 years old
• Tumor located in supplementary motor area
• No previous treatment history of central nervous system disease
• The patient received awaken craniotomy
• Pathological diagnosis is low grade glioma
• Volunteer to accept nrTMS treatment

Exclusion criteria

• The tumor grows across the midline to the opposite side
• Regarding rs-fMRI data, head movement exceeds 1mm and head deflection exceeds 1 °
• The patient did not have SMA syndrome after operation
• Vulnerable or special groups and protective measures, such as pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

TMS treatment

Experimental group

Description:

Using nrTMS coli to stimulate the thumb related motor cortex with high-frequency.

Treatment:

Device: TMS stimulation treatment

TMS Sham-treatment

Sham Comparator group

Description:

Using nrTMS sham-coli to stimulate the thumb related motor cortex with high-frequency.

Treatment:

Device: TMS stimulation sham-treatment