To hear about similar clinical trials, please enter your email below
Trial Title:
Accelerating Motor Recovering in Patients With SMA Syndrome After Glioma Surgery by Using nrTMS
NCT ID:
NCT05803057
Condition:
Motor Cortex; Lesion
Glioma
Supplementary Motor Area Syndrome
Conditions: Official terms:
Glioma
Syndrome
Conditions: Keywords:
human
motor recovery
transcranial magnetic stimulation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Intervention:
Intervention type:
Device
Intervention name:
TMS stimulation treatment
Description:
Using the TMS treatment coli to stimulation with high frequency
Arm group label:
TMS treatment
Intervention type:
Device
Intervention name:
TMS stimulation sham-treatment
Description:
Using the TMS sham-treatment coli to stimulation with high frequency
Arm group label:
TMS Sham-treatment
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.
Criteria for 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
Gender:
All
Minimum age:
25 Years
Maximum age:
55 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Neurosurgical Institute and Beijing Tiantan Hospital
Address:
City:
Beijing
Zip:
100005
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Jiang, MD and PhD
Phone:
+86-010-67021832
Email:
taojiang1964@163.com
Start date:
April 1, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Beijing Neurosurgical Institute
Agency class:
Other
Source:
Beijing Neurosurgical Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05803057
