DOI: 10.5281/zenodo.15672312
title: Individualized Closed-Loop Neuromodulation with Repetitive Transcranial Magnetic Stimulation Synchronized Task Training for Upper Limb Motor Dysfunction in Stroke Patients

description: Project description

The goal of this clinical trials is to investigate the effectiveness of individualized online repetitive transcranial magnetic stimulation (rTMS) in enhancing upper limb motor rehabilitation during the subacute and chronic phase of stroke. It will also learn about the safety of online rTMS intervention methods. The main questions it aims to answer are:





Does individualized rTMS precise target combined with motor training improve upper limb motor rehabilitation in patients?




Does individualized rTMS precise target combined with motor training enhance the upper limb motor rehabilitation ability in stroke patients by strengthening the functional coupling of the motor circuit to achieve functional reorganization of the brain network?Researchers will compare individualized online rTMS to non-individualized online and individualized sham stimulation in stroke patients to see if individualized online rTMS works to alleviate motor dysfunction in this randomized, sham-controlled, double-blind trial.



Participants

A total of 51 stroke patients meeting the inclusion criteria were enrolled and randomly assigned to three groups:



Personalized Online Stimulation Group: TMS treatment was guided by individualized targets identified through multimodal MRI, including structural imaging, resting-state/task-based functional MRI, and diffusion tensor imaging. Precise stimulation targets were determined, and coil positioning and orientation were optimized using electric field simulation. During treatment, patients performed specific upper-limb motor tasks, with TMS pulses triggered in real time by acceleration-EMG feedback upon task initiation and terminated immediately when the movement ceased, enabling real-time closed-loop intervention.

Non-Personalized Online Stimulation Group: Patients received TMS treatment synchronized with motor training tasks; however, stimulation targets were determined using conventional methods, such as placement guided by a standard cap, without individualized localization.

Personalized Sham Stimulation Group: Patients in this group performed the same task-specific training with TMS administered at the same individualized target locations as in the personalized group, but stimulation was delivered using a sham coil, providing no effective neuromodulation.


Participants were aged between 20 and 80 years, with no restrictions on sex or geographic distribution. Participants will:





randomized to one group;




receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks;




receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment;




conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.



The way of sharing IPD

Method of obtaining the raw data: If there are reasonable requests, the related raw data to support the research results can be obtained from the corresponding authors or the first authors. Time of making the raw data public: the research raw data will be publicly shared six months after the publication of the research paper.

Dataset and code description

To be uploaded...