NCT06849505

Transcranial Magnetic Stimulation Synchronized with Motor Task Training for Post-Stroke Rehabilitation

Closed - Loop Neuromodulation of Post - Stroke Motor Dysfunction by Transcranial Magnetic Stimulation Synchronized with Specific Motor Task Training

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University · 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 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 individualized online rTMS intervention methods. The main questions it aims to answer are: Does rTMS synchronized with motor training improve motor rehabilitation in patients with the ability to induce motor evoked potentials(MEPs)？ Dose individualized rTMS synchronized with motor training improve motor rehabilitation in patients without the ability to induce MEPs? Researchers will compare online rTMS to offline and sham stimulation in patients with MEPs to see if online rTMS works to alleviate motor dysfunction in preliminary trials. And compare individualized online rTMS to non-individualized online rTMS and sham in patients without MEPs to see if individualized online rTMS works to alleviate motor dysfunction in Randomized, double-blinded, and controlled trials. Participants will: randomized to one group acoording to the MEP condition of each person; 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.

Detailed description

In our experiment, 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% of TMS output.

Conditions

• Stroke
• Upper Extremity Parasis

Interventions

Type	Name	Description
DEVICE	online rTMS	5 Hz rTMS is applied to the MRI-localized hotspot on the affected hemisphere when the patients are performing motor tasks
DEVICE	offline rTMS	The patients perform motor tasks after 5 Hz rTMS applied to the MRI-guided hotspot on the affected hemisphere
DEVICE	sham rTMS	Sham rTMS is applied to the M1 on the affected hemisphere when the patients are performing motor tasks.

Timeline

• Start date: 2024-07-02
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2025-02-27
• Last updated: 2025-02-27

Locations

1 site across 1 country: China