Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours — RETRACE-I  

Stroke, Acute Clinical Trial

Official title: Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours (RETRACE-I): A Randomized, Open-label, Evaluator-blinded, Phase 2 Pilot Trial

Status Not yet recruiting

Clinical Trial Summary

This is a multicenter, open-label, evaluator-blinded, investigator-initiated, randomized clinical trial, to evaluate the clinical efficacy and safety of LF-rTMS in reducing infarct size, reducing disability rate and improving functional outcome in patients with acute ischemic stroke within 48 hours after stroke onset.

Clinical Trial Description

The target population of this study was patients with clinically diagnosed AIS who had an acute occlusion of the responsible vessel in the anterior circulation and were not scheduled for intravenous thrombolysis and/or endovascular therapy, the time from stroke onset to the start of study intervention was less than 48-hours.

Enrolled patients were randomly assigned in a 1:1 ratio to either the"LF-rTMS group" or the"Control group" to receive:

1. LF-rTMS group: H 4 Coil (stimulation site: prefrontal cortex, insular lobe),1-Hz rTMS, stimulation intensity RMT 100%,1200 pulses/session, two sessions (2400 pulses)/day (interval ≥2 hours), lasting about half an hour each time, the total duration of treatment was 3 days (6 sessions,7200 pulses).

2. Control group: received routine treatment.

All the above therapeutic interventions were conducted by trained TMS operators. Except for the study intervention, the subjects in both groups received clinical routine diagnosis and treatment which were not affected by the intervention.

All patients were followed up until the 90th day after randomization to evaluate the clinical efficacy and safety of LF-rTMS in reducing infarct size, reducing disability rate and improving functional outcome in patients with acute ischemic stroke within 48 hours after stroke onset. ;

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Acute
• Stroke, Ischemic

• NCT number: NCT06064734
• Study type: Interventional
• Source: Beijing Tiantan Hospital
• Contact: Zixiao Li, MD
• Phone: 86-13683234256
• Email: lizixiao2008@hotmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 28, 2023
• Completion date: October 30, 2024