Low-Frequency REpetitive TRanscranial Magnetic Stimulation Combined With Endovascular Treatment in ACute Ischemic StrokE

NCT06064747 | Completed DMC

• 1 other identifier: HX-A-2023002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, sham-controlled, investigator-initiated clinical study, to evaluate the clinical efficacy and safety of LF-rTMS in rescuing the ischemic penumbra, reducing disability rate and improving functional outcome in patients with acute ischemic stroke receiving early endovascular recanalization (bridging or direct endovascular therapy)

Conditions

Stroke, Acute Ischemic

Keywords

Acute ischemic stroke; LF-rTMS; Endovascular therapy; Phase 2 Pilot Trial

Outcome Measures

Primary Outcomes (2)

• Early neurological improvement (ENI)

  The 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

• Symptomatic intracranial hemorrhage

  The proportion of symptomatic intracranial hemorrhage

  3 days

Secondary Outcomes (11)

• Rescue penumbra ratio

  3 days

• Infarct volume progression

  3 days

• Final infarct volume

  7 and 90 days

• mRS scores of 0-1

  90 days

• mRS scores of 0-2

  90 days

Study Arms (2)

LF-rTMS

EXPERIMENTAL

Using "8" coil,1-Hz rTMS to stimulate the M1 region of the ipsilateral hemisphere, the stimulation intensity was RMT 100%, 1200pulses/session, two sessions (2400 pulses)/day (interval ≥ 2 hours), lasting 3 days (total 6 sessions, 7200pulses)

Device: LF-rTMS

Sham coil stimulation

SHAM COMPARATOR

The sham stimulation coil was used to stimulate the same site, duration and sound as the LF-rTMS group, ensuring no effective stimulation, twice a day for 3 days

Device: Sham stimulation

Interventions

LF-rTMS DEVICE

LF-rTMS group: using "8" coil,1-Hz rTMS to stimulate the M1 region of the ipsilateral hemisphere, the stimulation intensity was RMT 100%, 1200pulses/session, two sessions (2400 pulses)/day (interval ≥ 2 hours), lasting 3 days (total 6 sessions, 7200pulses);

LF-rTMS

Sham stimulation DEVICE

Sham stimulation group: the sham stimulation coil was used to stimulate the same site, duration and sound as the LF-rTMS group, ensuring no effective stimulation, twice a day for 3 days.

Sham coil stimulation

Eligibility Criteria

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

You may qualify if:

• years, male or female;
• Clinically diagnosed as acute anterior ischemic stroke, artery occlusion occurred at the terminal of the intracranial carotid artery, T-shaped bifurcation or M1 segment of the middle cerebral artery;
• Within 24 hours of stroke onset;
• Eligible for other imaging indications for bridging therapy or direct mechanical thrombectomy:
• ASPECTS ≥6 certified by the latest brain CT imaging; Patients within 6-16 hours after stroke onset should meet the mismatch criteria, which was defined as infarction core volume \<70 ml, mismatch ratio ≥1.8 and the ischemic volume \> 15 ml (DEFUSE-3 Criteria); or NIHSS score ≥ 10 with infarction -core volume \< 31 cm3, or NIHSS score ≥ 20 with infarction core volume ≤ 51 cm3 (DAWN Criteria); Patients within 16-24 hours after stroke onset should meet the mismatch criteria, which was defined as NIHSS score ≥ 10 with infarction-core volume \< 31 cm3, or NIHSS score ≥ 20 with infarction-core volume ≤ 51 cm3 (DAWN Criteria);
• Planned to receive bridging therapy (endovascular therapy after intravenous alteplase) or direct endovascular therapy;
• Pre-morbid modified Rankin Scale ≤1;
• ≤ NIHSS ≤ 25 before endovascular therapy;
• Signed informed consent from subjects or legally authorized representatives

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;
• CT or MRI showed a large area of infarction (\> 1/3 of the area supplied by middle cerebral artery);
• Evidence of acute intracranial hemorrhage;
• Before the bridging therapy, other thrombolytic drugs besides alteplase or tenecteplase were used;
• 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

Related Publications (1)

• Ding L, Wang W, Yi T, Zhang G, Han X, Chen W, Wang H, Wang Y, Li Z. Rationale and design of Low-Frequency REpetitive TRanscranial Magnetic Stimulation Combined with Endovascular Treatment in ACute Ischaemic StrokE (RETRACE II): a randomised double-blind controlled multicentre phase II pilot study. Stroke Vasc Neurol. 2025 Oct 28:svn-2025-004331. doi: 10.1136/svn-2025-004331. Online ahead of print.

  PMID: 40721316 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Yongjun MD Wang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In order to ensure the blind method, the sham stimulation coil was used, which had the same parameters (including location, stimulation frequency, time, etc.) as the LF-rTMS group, and had the same stimulation sound to ensure no effective stimulation, to ensure the blind state is maintained during the test. Investigators and patients who participated in the study treatment or involved in the clinical evaluation of patients were 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: May 25, 2024
• Primary Completion: April 15, 2025
• Study Completion: July 2, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)