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

NCT ID: NCT05803057

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-03-31

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.

Conditions

Motor Cortex; Lesion; Glioma; Supplementary Motor Area Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TMS treatment

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

Group Type: EXPERIMENTAL

TMS stimulation treatment

Intervention Type: DEVICE

Using the TMS treatment coli to stimulation with high frequency

TMS Sham-treatment

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

Group Type: SHAM_COMPARATOR

TMS stimulation sham-treatment

Intervention Type: DEVICE

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

Interventions

TMS stimulation treatment

Using the TMS treatment coli to stimulation with high frequency

Intervention Type: DEVICE

TMS stimulation sham-treatment

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Neurosurgical Institute

OTHER

Sponsor Role: lead

Responsible Party

TAO JIANG

Director, Department of Neurosurgery, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shengyu Fang, MD

Role: CONTACT

fangtuo1@aliyun.com

+8613466331405

Tao Jiang, MD

Role: CONTACT

taojiang1964@foxmail.com

+86-18610066686

Facility Contacts

Tao Jiang, MD and PhD

Role: primary

taojiang1964@163.com

+86-010-67021832

References

Nakajima R, Kinoshita M, Yahata T, Nakada M. Recovery time from supplementary motor area syndrome: relationship to postoperative day 7 paralysis and damage of the cingulum. J Neurosurg. 2019 Feb 8;132(3):865-874. doi: 10.3171/2018.10.JNS182391. Print 2020 Mar 1.

Reference Type: BACKGROUND

PMID: 30738403 (View on PubMed)

Fang S, Li L, Weng S, Zhang Z, Fan X, Jiang T, Wang Y. Increasing nodal vulnerability and nodal efficiency implied recovery time prolonging in patients with supplementary motor area syndrome. Hum Brain Mapp. 2022 Sep;43(13):3958-3969. doi: 10.1002/hbm.25896. Epub 2022 May 4.

Reference Type: RESULT

PMID: 35507429 (View on PubMed)

Other Identifiers

8220101798

Identifier Type: -

Identifier Source: org_study_id