Symptoms and General Pathology

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Rare Diseases

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Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

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.

Using the TMS treatment coli to stimulation with high frequency

TMS stimulation treatment

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

TMS stimulation sham-treatment

Shengyu Fang, MD

Tao Jiang, MD

Tao Jiang, MD and PhD

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.

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.

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.

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.

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

Beijing Neurosurgical Institute, Beijing, China

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).

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).

Beijing Neurosurgical Institute

Director, Department of Neurosurgery, Principal Investigator, Clinical Professor

Nervous System Diseases

Brain Neoplasms

Infratentorial Neoplasms

Cerebellar Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Cerebellar Diseases

With the TMS session we gather information about nerve fibres from the brain to the hand. It will last around 2 hours and 30 minutes.

Transcranial Magnetic Stimulation (TMS)

With the MRI scan we will gather information about the brain structure and function. This will last around 30 minutes.

Magnetic Resonance Imaging (MRI)

The motor assessment includes a pegboard game, a "grab the alien nose" game and measure of your maximum grip force. In total it will last around 30 minutes.

Motor assessment

Feasibility, tolerability of such intervention as well as quality of life of PFT survivors will be assessed thanks to questionnaires.

Questionnaires

Caroline Blanchard

Madhumati Dandapani

Posterior fossa tumours (PFT) account for 2/3 of childhood brain cancers. They can be highly malignant requiring combined chemotherapy and radiotherapy post-surgery for a \>50% chance of cure. PFT frequently involve the cerebellum which is responsible for coordinating movement, balance, emotional control, and links closely to control of affect and executive function. PFT survivors show highly variable profiles for cognitive and sensorimotor functioning which are influenced strongly by the severity of the pre-diagnostic or post-surgical brain injury

State-of-the-art magnetic resonance imaging (MRI) scans can allow to measure a variety of different biological processes in the brain, and the investigators believe that some of these MRI measures (called MRI biomarkers) have the potential to improve our ability to understand and monitor consequences of the ablative brain surgery and complex mechanisms of motor skills recovery. Biomarkers are very important for the development of intervention because 1) they help understand the recuperation process and 2) they allow to effectively assess whether or not a treatment or intervention works.

Transcranial magnetic stimulation (TMS) is a powerful non-invasive neuro-modulatory intervention that has the potential to evaluate the integrity of the nervous tracts from the brain to the hand. It is a procedure that applies magnetic pulses on the surface of the scalp to reach underlying brain tissue. TMS has built a reputable status among neuro-rehabilitative research, and there is currently a major effort to translate the positive research findings into clinically useful therapeutic strategies.

This study is therefore an important first step towards understanding how potential MRI biomarkers and responses to TMS relate to motor symptoms in PFT young survivors. Once completed, this study will allow the investigators to select the most promising MRI biomarkers and TMS protocols to take forward into future treatment trials. The investigators aim to stimulate the recovery of coordination skills, help the development of targeted therapies, and consequently improve long-term quality of life in children and young people with history of brain tumour.

The proposed research intends to prove the feasibility of such brain stimulation and imaging and collect some preliminary measures

Controlling Coordination After Childhood Cerebellar Cancer, a Pilot Study

Controlling Coordination After Childhood Cerebellar Cancer - Pilot Study

Participants rating their experience of MRI, TMS and motor assessment

Measure of quality of MRI images (participants motion) - Feasibility will be confirmed if 50% or more of these participants complete the TMS session

Cerebellar volumetry and cerebellar parcellation - after surgery (mm3)

Functional connectivity within sensorimotor network (activation map)

Anatomical connectivity within sensorimotor network (tractography)

Resting motor threshold (Stimulus intensity expressed as a percentage of maximal stimulator output)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Accelerating Motor Recovering in Patients With SMA Syndrome After Glioma Surgery by Using nrTMS	NCT05803057	Motor Cortex; L... Glioma Supplementary M...	TMS stimulation... TMS stimulation...	25 Years - 55 Years	Beijing Neurosurgical Institute
Controlling Coordination After Childhood Cerebellar Cancer, a Pilot Study	NCT04501731	Brain Cancer	Transcranial Ma... Magnetic Resona... Motor assessmen... Questionnaires	16 Years - 22 Years	University of Nottingham

Spots Global Cancer Trial Database for motor recovery