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

NCT05803057 | Unknown DMC

• 1 other identifier: 8220101798
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Motor Cortex; Lesion; Glioma; Supplementary Motor Area Syndrome

Keywords

human; motor recovery; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• 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).

  From the day of tumor resection to 3 months after tumor resection

Secondary Outcomes (1)

• Motor function improve in evaluating with MRC (the UK Medical Research Council) muscle strength test

  From the day of tumor resection to 3 months after tumor resection

Study Arms (2)

TMS treatment

EXPERIMENTAL

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

Device: TMS stimulation treatment

TMS Sham-treatment

SHAM COMPARATOR

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

Device: TMS stimulation sham-treatment

Interventions

TMS stimulation treatment DEVICE

Using the TMS treatment coli to stimulation with high frequency

TMS treatment

TMS stimulation sham-treatment DEVICE

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

TMS Sham-treatment

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Neurosurgical Institute: lead

Study Sites (1)

Beijing Neurosurgical Institute and Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 30738403 BACKGROUND

• 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.

  PMID: 35507429 RESULT

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Shengyu Fang, MD

CONTACT

+8613466331405; fangtuo1@aliyun.com

Tao Jiang, MD

CONTACT

+86-18610066686; taojiang1964@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Neurosurgery, Principal Investigator, Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 7, 2023
• Study Start: April 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2025
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)