Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT06064734
Status:
UNKNOWN
Last Update Posted:
2023-10-03
First Post:
2023-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours
Sponsor:
Beijing Tiantan Hospital
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETRACE-I
Brief 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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: