NCT06752499

rTMS Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Patients

Individualized rTMS Concurrent With Motor Actions Promotes Post-stroke Upper Limb Recovery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trials is to investigate the effectiveness of 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: 1. Does rTMS combined with motor training improve motor rehabilitation in patients？ 2. Does repetitive transcranial magnetic stimulation (rTMS) 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 online rTMS to offline and sham stimulation in stroke patients to see if online rTMS works to alleviate motor dysfunction in multicenter multicenter, blinded and controlled trial. Participants will: 1. randomized to one group(online, offline or sham); 2. receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks; 3. receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment; 4. conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.

Detailed description

In this study, patients were be randomly assigned to three groups: online, offline and sham groups. if patients were able to induce MEPs, intensity of TMS will be 80% RMT; if not , inensity of TMS will be 70%\~80% of TMS output. Patients were stimulated over 2 week period, 4 sessions of tasks were performed everyday. The patient will undergo a 2-week (10-day) stimulation protocol, with fourty tasks performed daily. This includes one session of 10 baseline tasks measurement and three sessions of 5 Hz rTMS synchronized with 10 motor tasks. rTMS will be applied to the ipsilesional motor cortex.

Conditions

• Stroke
• Upper Extremity Paresis

Interventions

Type	Name	Description
DEVICE	Online stimulation	5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
DEVICE	Offline stimulation	After 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks.
DEVICE	Sham stimulation	Sham rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.

Timeline

• Start date: 2023-02-20
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-12-30
• Last updated: 2025-12-04

Locations

3 sites across 1 country: China