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

April 30, 2023 updated by: TAO JIANG, Beijing Neurosurgical Institute

Beijing Neurosurgical Institute, Beijing, China

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor function totally recovering in evaluating with MRC (the UK Medical Research Council) muscle strength test
Time Frame: 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).
From the day of tumor resection to 3 months after tumor resection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor function improve in evaluating with MRC (the UK Medical Research Council) muscle strength test
Time Frame: 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).
From the day of tumor resection to 3 months after tumor resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Neurosurgical Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 25, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 30, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8220101798

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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