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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	25 Years - 55 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05803057
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Neurosurgical Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Motor Cortex; Lesion, Glioma, Supplementary Motor Area Syndrome

Additional Details

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.

Arms & Interventions

Arms

Experimental: TMS treatment

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

Sham Comparator: TMS Sham-treatment

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

Interventions

Device: - TMS stimulation treatment

Using the TMS treatment coli to stimulation with high frequency

Device: - TMS stimulation sham-treatment

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

Contact a Trial Team

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International Sites

Beijing, Beijing, China

Status

Recruiting

Address

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing, 100005

Site Contact

Tao Jiang, MD and PhD

taojiang1964@163.com

+86-010-67021832

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