Accelerating Motor Recovery in Glioma Patients Using Postoperative nrTMS

NCT07285525 | Active Not Recruiting

• 2 other identifiers: BRWEP2024W032040210Beijing Municipal Health Commi
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Project Name Clinical Research Protocol on Accelerating Motor Rehabilitation in Postoperative Motor-Deficient Glioma Patients Using nrTMS Research Objectives

1. 1.Investigate the relationship between motor rehabilitation and changes in motor functional networks after nrTMS therapy, and confirm the contralateral hand motor area as an effective rehabilitation target.
2. 2.Validate the efficacy of high-frequency nrTMS stimulation in rehabilitating motor deficits in glioma patients.

Conditions

Glioma

Keywords

Glioma; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Muscle strength of the affected limb

  Motor function recovery is defined as the affected limb's muscle strength returning to preoperative levels.

  muscle strength of the affected limb have returned to preoperative levels at pre-treatment, post-treatment, 1 month postoperative, 2 months postoperative, and 3 months postoperative.

Secondary Outcomes (1)

• Rate of Fugl-Meyer Assessment (FMA) Score Recovery for the Affected Upper Limb

  Assessed at pre-treatment (postoperative day 7), post-treatment (after 7 days of intervention), 1 month, 2 months, and 3 months postoperatively.

Study Arms (2)

Sham Comparator

SHAM COMPARATOR

Device: sham stimulation

nrTMS

EXPERIMENTAL

Device: transcranial magnetic stimulation (TMS)

Interventions

transcranial magnetic stimulation (TMS) DEVICE

Method for determining stimulation threshold: Using a positioning coil, based on the T1-3D MRI sequence and anatomical structure, single-pulse stimulation will be applied to the contralateral hand motor area. The stimulation intensity will be gradually increased from 50% until the action potential of the thenar eminence muscles exceeds 50 μV or until involuntary thumb movement occurs. High-frequency stimulation treatment: Localization of the ipsilateral thumb motor area: The positive points of intraoperative thumb motor area monitoring will be marked on the postoperative T1-3D image as the preferred target. Using the positioning coil, the target and surrounding areas will be stimulated, starting at 90% of the stimulation threshold intensity and increasing by 5% each time until involuntary thumb movement or an action potential of the thenar eminence muscles exceeding 50 μV is elicited. This point will be identified as the stimulation target. The treatment coil will be adjusted in angle

nrTMS

sham stimulation DEVICE

Sham Stimulation Treatment: Target Localization: The same preferred target, based on the intraoperative thumb motor area monitoring points marked on the postoperative T1-3D image, will be used for coil placement to maintain consistency with the active treatment group. Stimulation Protocol: The sham treatment coil will be positioned over the ipsilateral thumb motor area. The stimulation will be delivered using parameters that replicate the auditory and somatosensory experience (e.g., clicking sound, scalp tapping) of real high-frequency nrTMS, but the magnetic field will be designed to not penetrate the cortex effectively. The intensity will be set to mimic the protocol of the active group (0% of a simulated threshold) without delivering neurologically effective stimulation. The coil angle may be adjusted to enhance the blinding by replicating the procedural steps of the active treatment.

Sham Comparator

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Right-handed.
• Age between 25 and 65 years old.
• No history of neurological disease treatment before surgery.
• Underwent awake surgery with intraoperative direct cortical stimulation or motor evoked potential (MEP) mapping to identify the motor functional area.
• Postoperative pathology confirmed as newly diagnosed glioma.
• Eligible for navigated repetitive transcranial magnetic stimulation (nrTMS) rehabilitation treatment.
• Persistent motor dysfunction (muscle strength or Fugl-Meyer Assessment (FMA) scores not returned to preoperative levels) at 7 days postoperatively.
• Signed informed consent.

You may not qualify if:

• Tumor crossing the midline to the contralateral hemisphere.
• Excessive head motion (\>1 mm translation or \>1° rotation) during resting-state functional MRI (rs-fMRI) data acquisition.
• Absence of postoperative motor or language motor deficits.
• Vulnerable populations (e.g., pregnant women).

Sponsors & Collaborators

• Beijing Neurosurgical Institute: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, None Selected, 410008, China

Location

Related Publications (1)

• 1. Potgieser AR, de Jong BM, Wagemakers M, Hoving EW, Groen RJ. Insights from the supplementary motor area syndrome in balancing movement initiation and inhibition. Front Hum Neurosci 2014;8:960. 2. Morone G, Capone F, Iosa M, et al. May Dual Transcranial Direct Current Stimulation Enhance the Efficacy of Robot-Assisted Therapy for Promoting Upper Limb Recovery in Chronic Stroke? Neurorehabil Neural Repair 2022;36:800-809. 3. Youssef H, Mohamed NAE, Hamdy M. Comparison of bihemispheric and unihemispheric M1 transcranial direct current stimulations during physical therapy in subacute stroke patients: A randomized controlled trial. Neurophysiol Clin 2023;53:102895. 4. Bikson M, Hanlon CA, Woods AJ, et al. Guidelines for TMS/tES clinical services and research through the COVID-19 pandemic. Brain Stimul 2020;13:1124-1149. 5. Steeves T, McKinlay BD, Gorman D, et al. Canadian guidelines for the evidence-based treatment of tic disorders: behavioural therapy, deep brain stimulation, and transcranial magnetic stimulation. Can J Psychiatry 2012;57:144-151. 6. 中国医师协会神经调控专业委员会电休克与神经刺激学组. 重复经颅磁刺激治疗专家共识. 转化医学杂志 2018;7:4-9. 7. Krieg SM, Shiban E, Buchmann N, et al. Utility of presurgical navigated transcranial magnetic brain stimulation for the resection of tumors in eloquent motor areas. J Neurosurg 2012;116:994-1001. 8. 王引言, 方晟宇, 李连旺, et al. 重复经颅磁刺激治疗脑胶质瘤术后运动功能障碍的临床分析(附五例报告). 中华神经外科杂志 2020;36:458-462. 9. Herbet G, Maheu M, Costi E, Lafargue G, Duffau H. Mapping neuroplastic potential in brain-damaged patients. Brain : a journal of neurology 2016;139:829-844. 10. Almairac F, Duffau H, Herbet G. Contralesional macrostructural plasticity of the insular cortex in glioma patients. Neurology 2018:1. 11. Duffau H. Functional Mapping before and after Low-Grade Glioma Surgery: A New Way to Decipher Various Spatiotemporal Patterns of Individual Neuroplastic Potential in Brain Tumor Patients. Cancers (Basel) 2020;12. 12. Duffau H. Hodotopy, neuroplasticity and diffuse gliomas. Neurochirurg

  RESULT

MeSH Terms

Conditions

Glioma

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: December 16, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)