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

Not Applicable

Recruiting

• Conditions: Supplementary Motor Area Syndrome; Motor Cortex; Lesion; Glioma
• Interventions: Device: TMS stimulation sham-treatment; Device: TMS stimulation treatment

• Registration Number: NCT05803057
• Lead Sponsor: Beijing Neurosurgical Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-25
• Status Verified: 2023-04
• Study Start: 2023-04-01
• Study First Posted: 2023-04-07
• Last Update Submitted: 2023-04-30
• Last Update Posted: 2023-05-03
• Primary Completion: 2024-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMS Sham-treatment	TMS stimulation sham-treatment	Using nrTMS sham-coli to stimulate the thumb related motor cortex with high-frequency.
TMS treatment	TMS stimulation treatment	Using nrTMS coli to stimulate the thumb related motor cortex with high-frequency.

Primary Outcome Measures

Name	Time	Method
Motor function totally recovering in evaluating with MRC (the UK Medical Research Council) muscle strength test	From the day of tumor resection to 3 months after tumor resection	The motor function recovers back to the status in pre-operation. The motor status means that the muscle strength muscle of upper limb that is controlled by lesional hemisphere. Moreover, the recovering back means that the muscle strength achieves at grade 5 (healthy grade).

Secondary Outcome Measures

Name	Time	Method
Motor function improve in evaluating with MRC (the UK Medical Research Council) muscle strength test	From the day of tumor resection to 3 months after tumor resection	The motor function improves compared with the day of SMA syndrome occuring. The motor status means that the strength muscle of upper limb that is controlled by lesional hemisphere. Moreover, the motor imporvement means that the muscle strength is higher than the SMA syndrome occurring but does not achieve grade 5 (healthy grade).

Trial Locations

Locations (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China