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

NCT06064734 | Completed DMC

• 1 other identifier: HX-A-2023001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute; Stroke, Ischemic

Keywords

Acute Ischemic Stroke; LF-rTMS; Phase 2 Pilot Trial

Outcome Measures

Primary Outcomes (2)

• Infarct growth from baseline to Day 3 (mL)

  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. Positive values indicate infarct growth.

  3 days

• Symptomatic intracranial hemorrhage

  The proportion of symptomatic intracranial hemorrhage

  3 days

Secondary Outcomes (14)

• Proportion of Early neurological improvement (ENI)

  3 days

• Final infarct volume at Day 3 (mL)

  3 days

• Change in NIHSS score from baseline to Day 3

  3 days

• Proportion of participants with modified Rankin Scale score 0 to 1 at Day 90

  90 days

• Proportion of participants with modified Rankin Scale score 0 to 2 at Day 90

  90 days

Other Outcomes (3)

• Change in resting-state functional connectivity in the insular-prefrontal circuit.

  90 days

• Change in peripheral immune biomarker levels from baseline to Day 3

  3 days

• Change in peripheral immune biomarker levels from baseline to Day 7

  7 days

Study Arms (2)

LF-rTMS

EXPERIMENTAL

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).

Device: LF-rTMS

Control

NO INTERVENTION

Routine treatment.

Interventions

LF-rTMS DEVICE

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).

LF-rTMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years, gender is not limited;
• Acute ischemic stroke of anterior circulation was diagnosed clinically
• mRS 0-1 score before onset;
• ≤ 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.

You may not qualify if:

• 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, brainstem infarction, or 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian tan Hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yongjun Wang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigators involved in the clinical evaluation of the patients remained blinded to treatment grouping.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: October 3, 2023
• Study Start: March 11, 2024
• Primary Completion: July 28, 2025
• Study Completion: October 25, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)