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

Stroke, Acute Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06064734
• Other study ID #: HX-A-2023001
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 28, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: September 2023
• Source: Beijing Tiantan Hospital
• Contact: Zixiao Li, MD
• Phone: 86-13683234256
• Email: lizixiao2008[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 18-80 years, gender is not limited;

2. Acute ischemic stroke of anterior circulation was diagnosed clinically

3. mRS 0-1 score before onset;

4. 6 = NIHSS =25 at randomization;

5. Within 48 hours of stroke onset;

6. No thrombolysis therapy or thrombectomy is planned;

7. Obtain informed consent signed by the patient himself or by his legal authorized representative.

Exclusion Criteria:

1. TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc.

2. Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders;

3. Midline displacement and brain parenchymal mass effect seen in head CT and other images;

4. Head CT or MRI showed bilateral acute cerebral infarction and involved insular infarction;

5. Evidence of acute intracranial hemorrhage;

6. A history of congenital or acquired hemorrhagic disease, coagulation factor deficiency, or thrombocytopenia disease;

7. After blood pressure control, the systolic blood pressure was still =180 mmHg or the diastolic blood pressure was =110 mmHg;

8. Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal or estimated glomerular filtration rate (EGFR) < 60 mL/min;

9. Patients during pregnancy or lactation and within 90 days of planned pregnancy;

10. Patients with severe mental disorders or dementia who can not cooperate with informed consent and follow-up;

11. Patients with malignancy or severe systemic disease and expected survival of less than 90 days;

12. Participants in other clinical intervention studies within 30 days before randomization or who were participating in other clinical intervention studies.

Related Conditions & MeSH terms

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

Intervention

Device:
• LF-rTMS
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).

Locations

Country	Name	City	State
China	Beijing Tian tan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 days
Primary	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	3 days
Primary	Symptomatic intracranial hemorrhage	The proportion of symptomatic intracranial hemorrhage	3 days
Secondary	Final infarct volume	Final infarct volume	3 days
Secondary	?NIHSS score	Change in NIHSS score from baseline	3 days
Secondary	mRS scores of 0-1	Proportion of patients with mRS scores of 0-1	90 days
Secondary	mRS scores of 0-2	Proportion of patients with mRS scores of 0-2	90 days
Secondary	Barthel index of ADL	Barthel index of ADL, 0-100 (better)	90 days
Secondary	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."	90 days
Secondary	Montreal Cognitive Assessment (MoCA) total score	Total score of the MoCA Performance on the MoCA (0-30; higher score indicates better performance)	90 days
Secondary	Serious adverse events	The proportion of serious adverse events (SAE)	90 days
Secondary	All-cause deaths	The proportion of all-cause deaths	90 days
Secondary	Symptomatic intracranial hemorrhage	The incidence of symptomatic intracranial hemorrhage	90 days
Secondary	Deterioration of neurological function	The incidence of deterioration of neurological function (NIHSS increase =4 points)	3 days
Secondary	Stroke recurrence	Recurrence rate of symptomatic stroke (cerebral infarction, cerebral hemorrhage)	90 days
Secondary	Adverse events (AE)	The proportion of adverse events (AE)	90 days