Accelerating Motor Recovery in Glioma Patients Using Postoperative nrTMS

Summary

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

Research Objectives

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. Validate the efficacy of high-frequency nrTMS stimulation in rehabilitating motor deficits in glioma patients.

Study Design \> A randomized, double-blind, sham-controlled clinical trial. Eligible postoperative glioma patients with motor dysfunction will be randomized into nrTMS treatment or sham groups. High-frequency nrTMS or sham stimulation targeting the contralateral hand motor area will be administered for 7 consecutive days. Fugl-Meyer Assessment (FMA) scores and muscle strength of the affected limb will be evaluated to determine the superiority of nrTMS over sham stimulation.

Total Cases The study comprises two parts, each enrolling 43 patients.

Case Selection Inclusion Criteria:

A. Right-handed; B. Age: 25-65 years; C. No prior neurological disease history; D. Awake craniotomy with intraoperative direct cortical stimulation or MEP mapping for motor area localization; E. Postoperative pathology confirms newly diagnosed glioma; F. Willing to undergo nrTMS therapy; G. Persistent motor dysfunction (muscle strength/FMA score not restored to preoperative levels) at postoperative day 7.

Exclusion Criteria:

A. Tumor crossing midline to the contralateral hemisphere; B. Head motion \>1 mm or rotation \>1° during rs-fMRI acquisition; C. Absence of postoperative motor or speech dysfunction; D. Vulnerable populations (e.g., pregnant women). Treatment Protocol High-frequency nrTMS stimulation targeting the contralateral hand motor area (thumb region).

Efficacy Evaluation Primary Outcome: Muscle strength recovery rate of the affected limb.

Secondary Outcome: FMA score recovery rate. Safety Evaluation: Pre- and post-treatment MRI to monitor intracranial changes. Statistical Methods (1) Randomization into nrTMS and sham groups. (2) Baseline comparisons using t-tests and chi-square tests. (3) Longitudinal analysis of muscle strength (chi-square) and FMA scores (t-tests) at key timepoints: preoperative, pretreatment, post-treatment, 1/2/3 months postoperatively.

Conditions

• Glioma

Interventions

DEVICE

transcranial magnetic stimulation (TMS)

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

DEVICE

sham stimulation

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.

Sponsors & Collaborators

• Beijing Neurosurgical Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2027-10-01

Completion

2027-10-01

Countries

• China

Study Locations