Clinical trial NCT05803057: Accelerating Motor Recovering in Patients With SMA Syndrome After Glioma Surgery by Using nrTMS
Official title: Beijing Neurosurgical Institute, Beijing, China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motor Cortex; Lesion
Glioma
Supplementary Motor Area Syndrome
Keywords: human
motor recovery
transcranial magnetic stimulation
Lead sponsor: Beijing Neurosurgical Institute
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 64
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Motor function totally recovering in evaluating with MRC (the UK Medical Research Council) muscle strength test
timeFrame: From the day of tumor resection to 3 months after tumor resection
Secondary outcomes:
measure: Motor function improve in evaluating with MRC (the UK Medical Research Council) muscle strength test
timeFrame: From the day of tumor resection to 3 months after tumor resection
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Neurosurgical Institute and Beijing Tiantan Hospital
state: Beijing
Study officials:
References:
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. Print 2020 Mar 1.
citation: 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.