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

Primary Purpose

Stroke, Acute, Stroke, Ischemic

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LF-rTMS
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Acute Ischemic Stroke, LF-rTMS, Phase 2 Pilot Trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-80 years, gender is not limited; Acute ischemic stroke of anterior circulation was diagnosed clinically mRS 0-1 score before onset; 6 ≤ NIHSS ≤25 at randomization; Within 48 hours of stroke onset; No thrombolysis therapy or thrombectomy is planned; Obtain informed consent signed by the patient himself or by his legal authorized representative. Exclusion Criteria: TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc. Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders; Midline displacement and brain parenchymal mass effect seen in head CT and other images; Head CT or MRI showed bilateral acute cerebral infarction and involved insular infarction; Evidence of acute intracranial hemorrhage; A history of congenital or acquired hemorrhagic disease, coagulation factor deficiency, or thrombocytopenia disease; After blood pressure control, the systolic blood pressure was still ≥180 mmHg or the diastolic blood pressure was ≥110 mmHg; Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal or estimated glomerular filtration rate (EGFR) < 60 mL/min; Patients during pregnancy or lactation and within 90 days of planned pregnancy; Patients with severe mental disorders or dementia who can not cooperate with informed consent and follow-up; Patients with malignancy or severe systemic disease and expected survival of less than 90 days; Participants in other clinical intervention studies within 30 days before randomization or who were participating in other clinical intervention studies.

Sites / Locations

  • Beijing Tian tan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LF-rTMS

Control

Arm Description

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).

Routine treatment.

Outcomes

Primary Outcome Measures

Infarct growth
Infarct growth at 3 days was calculated as the absolute difference between the baseline core infarct volume and the 3 days post-randomization infarct volume.
Proportion of Early neurological improvement (ENI)
Proportion of patients with a reduction of ≥4 on the NIHSS, compared with the baseline score or an NIHSS of 0 or 1
Symptomatic intracranial hemorrhage
The proportion of symptomatic intracranial hemorrhage

Secondary Outcome Measures

Final infarct volume
Final infarct volume
△NIHSS score
Change in NIHSS score from baseline
mRS scores of 0-1
Proportion of patients with mRS scores of 0-1
mRS scores of 0-2
Proportion of patients with mRS scores of 0-2
Barthel index of ADL
Barthel index of ADL, 0-100 (better)
EQ-5D-5L
The Health Questionnaire (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems."
Montreal Cognitive Assessment (MoCA) total score
Total score of the MoCA Performance on the MoCA (0-30; higher score indicates better performance)
Serious adverse events
The proportion of serious adverse events (SAE)
All-cause deaths
The proportion of all-cause deaths
Symptomatic intracranial hemorrhage
The incidence of symptomatic intracranial hemorrhage
Deterioration of neurological function
The incidence of deterioration of neurological function (NIHSS increase ≥4 points)
Stroke recurrence
Recurrence rate of symptomatic stroke (cerebral infarction, cerebral hemorrhage)
Adverse events (AE)
The proportion of adverse events (AE)

Full Information

First Posted
August 24, 2023
Last Updated
September 26, 2023
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06064734
Brief Title
Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours
Acronym
RETRACE-I
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 28, 2023 (Anticipated)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Stroke, Ischemic
Keywords
Acute Ischemic Stroke, LF-rTMS, Phase 2 Pilot Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The investigators involved in the clinical evaluation of the patients remained blinded to treatment grouping.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LF-rTMS
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine treatment.
Intervention Type
Device
Intervention Name(s)
LF-rTMS
Intervention Description
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).
Primary Outcome Measure Information:
Title
Infarct growth
Description
Infarct growth at 3 days was calculated as the absolute difference between the baseline core infarct volume and the 3 days post-randomization infarct volume.
Time Frame
3 days
Title
Proportion of Early neurological improvement (ENI)
Description
Proportion of patients with a reduction of ≥4 on the NIHSS, compared with the baseline score or an NIHSS of 0 or 1
Time Frame
3 days
Title
Symptomatic intracranial hemorrhage
Description
The proportion of symptomatic intracranial hemorrhage
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Final infarct volume
Description
Final infarct volume
Time Frame
3 days
Title
△NIHSS score
Description
Change in NIHSS score from baseline
Time Frame
3 days
Title
mRS scores of 0-1
Description
Proportion of patients with mRS scores of 0-1
Time Frame
90 days
Title
mRS scores of 0-2
Description
Proportion of patients with mRS scores of 0-2
Time Frame
90 days
Title
Barthel index of ADL
Description
Barthel index of ADL, 0-100 (better)
Time Frame
90 days
Title
EQ-5D-5L
Description
The Health Questionnaire (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems."
Time Frame
90 days
Title
Montreal Cognitive Assessment (MoCA) total score
Description
Total score of the MoCA Performance on the MoCA (0-30; higher score indicates better performance)
Time Frame
90 days
Title
Serious adverse events
Description
The proportion of serious adverse events (SAE)
Time Frame
90 days
Title
All-cause deaths
Description
The proportion of all-cause deaths
Time Frame
90 days
Title
Symptomatic intracranial hemorrhage
Description
The incidence of symptomatic intracranial hemorrhage
Time Frame
90 days
Title
Deterioration of neurological function
Description
The incidence of deterioration of neurological function (NIHSS increase ≥4 points)
Time Frame
3 days
Title
Stroke recurrence
Description
Recurrence rate of symptomatic stroke (cerebral infarction, cerebral hemorrhage)
Time Frame
90 days
Title
Adverse events (AE)
Description
The proportion of adverse events (AE)
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years, gender is not limited; Acute ischemic stroke of anterior circulation was diagnosed clinically mRS 0-1 score before onset; 6 ≤ NIHSS ≤25 at randomization; Within 48 hours of stroke onset; No thrombolysis therapy or thrombectomy is planned; Obtain informed consent signed by the patient himself or by his legal authorized representative. Exclusion Criteria: TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc. Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders; Midline displacement and brain parenchymal mass effect seen in head CT and other images; Head CT or MRI showed bilateral acute cerebral infarction and involved insular infarction; Evidence of acute intracranial hemorrhage; A history of congenital or acquired hemorrhagic disease, coagulation factor deficiency, or thrombocytopenia disease; After blood pressure control, the systolic blood pressure was still ≥180 mmHg or the diastolic blood pressure was ≥110 mmHg; Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal or estimated glomerular filtration rate (EGFR) < 60 mL/min; Patients during pregnancy or lactation and within 90 days of planned pregnancy; Patients with severe mental disorders or dementia who can not cooperate with informed consent and follow-up; Patients with malignancy or severe systemic disease and expected survival of less than 90 days; Participants in other clinical intervention studies within 30 days before randomization or who were participating in other clinical intervention studies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zixiao Li, MD
Phone
86-13683234256
Email
lizixiao2008@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lingling Ding, MD
Phone
86-13552358752
Email
dll_ing@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tian tan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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