search
Back to results

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

Primary Purpose

Motor Cortex; Lesion, Glioma, Supplementary Motor Area Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TMS stimulation treatment
TMS stimulation sham-treatment
Sponsored by
Beijing Neurosurgical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motor Cortex; Lesion focused on measuring human, motor recovery, transcranial magnetic stimulation

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Neurosurgical Institute and Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TMS treatment

TMS Sham-treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
March 14, 2023
Last Updated
April 30, 2023
Sponsor
Beijing Neurosurgical Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT05803057
Brief Title
Accelerating Motor Recovering in Patients With SMA Syndrome After Glioma Surgery by Using nrTMS
Official Title
Beijing Neurosurgical Institute, Beijing, China
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Neurosurgical Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motor Cortex; Lesion, Glioma, Supplementary Motor Area Syndrome
Keywords
human, motor recovery, transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
There are two stimulating colis with the same shape, color and touch. The one is able to stimulate, the other is able to sham-stimulate. All patients are randomly assigned to use one of the two coils for treatment. Except for the designer, all participant, care provider, investigator, and outcomes assessorthey don not know who used which coil to treatment.
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMS treatment
Arm Type
Experimental
Arm Description
Using nrTMS coli to stimulate the thumb related motor cortex with high-frequency.
Arm Title
TMS Sham-treatment
Arm Type
Sham Comparator
Arm Description
Using nrTMS sham-coli to stimulate the thumb related motor cortex with high-frequency.
Intervention Type
Device
Intervention Name(s)
TMS stimulation treatment
Intervention Description
Using the TMS treatment coli to stimulation with high frequency
Intervention Type
Device
Intervention Name(s)
TMS stimulation sham-treatment
Intervention Description
Using the TMS sham-treatment coli to stimulation with high frequency
Primary Outcome Measure Information:
Title
Motor function totally recovering in evaluating with MRC (the UK Medical Research Council) muscle strength test
Description
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).
Time Frame
From the day of tumor resection to 3 months after tumor resection
Secondary Outcome Measure Information:
Title
Motor function improve in evaluating with MRC (the UK Medical Research Council) muscle strength test
Description
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).
Time Frame
From the day of tumor resection to 3 months after tumor resection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengyu Fang, MD
Phone
+8613466331405
Email
fangtuo1@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Jiang, MD
Phone
+86-18610066686
Email
taojiang1964@foxmail.com
Facility Information:
Facility Name
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Jiang, MD and PhD
Phone
+86-010-67021832
Email
taojiang1964@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30738403
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.
Results Reference
background
PubMed Identifier
35507429
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs