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

Sponsor

Beijing Neurosurgical Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05803057

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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 patients with SMA syndrome after glioma resection.
Question 2: Whether the nrTMS was useful to improve postoperative motor function in patients 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. We will evaluate the effects of nrTMS treatment through the ratio of recovery of motor function and the time that was from the patient suffering SMA syndrome to totally recover the motor function to the status of motor function in pre-operation.

Condition or Disease	Intervention/Treatment	Phase
Motor Cortex; Lesion Glioma Supplementary Motor Area Syndrome	Device: TMS stimulation treatment Device: TMS stimulation sham-treatment	N/A

Detailed Description

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:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

There are two groups of this study. The one is that the patients receive nrTMS stimulation with high-frequency on the thumb-related motor cortex on the lesional hemisphere. The other is that the patients receive nrTMS sham-stimulation with high-frequency on the thumb-related motor cortex on the lesional hemisphere.There are two groups of this study. The one is that the patients receive nrTMS stimulation with high-frequency on the thumb-related motor cortex on the lesional hemisphere. The other is that the patients receive nrTMS sham-stimulation with high-frequency on the thumb-related motor cortex on the lesional hemisphere.

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.

Primary Purpose:

Treatment

Official Title:

Beijing Neurosurgical Institute, Beijing, China

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TMS treatment Using nrTMS coli to stimulate the thumb related motor cortex with high-frequency.	Device: TMS stimulation treatment Using the TMS treatment coli to stimulation with high frequency
Sham Comparator: TMS Sham-treatment Using nrTMS sham-coli to stimulate the thumb related motor cortex with high-frequency.	Device: TMS stimulation sham-treatment Using the TMS sham-treatment coli to stimulation with high frequency

Arm

Intervention/Treatment

Experimental: TMS treatment

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

Device: TMS stimulation treatment

Using the TMS treatment coli to stimulation with high frequency

Sham Comparator: TMS Sham-treatment

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

Device: TMS stimulation sham-treatment

Using the TMS sham-treatment coli to stimulation with high frequency

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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