Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06064734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-03
First Post:
2023-08-24
Brief Title:
Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
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:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
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 andor 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 11 ratio to either theLF-rTMS group or theControl group to receive
1 LF-rTMS group H 4 Coil stimulation site prefrontal cortex insular lobe1-Hz rTMS stimulation intensity RMT 1001200 pulsessession two sessions 2400 pulsesday interval 2 hours lasting about half an hour each time the total duration of treatment was 3 days 6 sessions7200 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 11 ratio to either theLF-rTMS group or theControl group to receive
1 LF-rTMS group H 4 Coil stimulation site prefrontal cortex insular lobe1-Hz rTMS stimulation intensity RMT 1001200 pulsessession two sessions 2400 pulsesday interval 2 hours lasting about half an hour each time the total duration of treatment was 3 days 6 sessions7200 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:
None
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?:
None