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

Glioma Clinical Trial

Official title:

Beijing Neurosurgical Institute, Beijing, China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803057
• Other study ID #: 8220101798
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2023
• Source: Beijing Neurosurgical Institute
• Contact: Shengyu Fang, MD
• Phone: +8613466331405
• Email: fangtuo1[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Motor Cortex; Lesion
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Beijing Neurosurgical Institute and Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Neurosurgical Institute

Country where clinical trial is conducted

China, 

References & Publications (2)

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.258 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor function totally recovering in evaluating with MRC (the UK Medical Research Council) muscle strength test	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).	From the day of tumor resection to 3 months after tumor resection
Secondary	Motor function improve in evaluating with MRC (the UK Medical Research Council) muscle strength test	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).	From the day of tumor resection to 3 months after tumor resection