NCT06064747Completed
Low-Frequency REpetitive TRanscranial Magnetic Stimulation Combined With Endovascular Treatment in ACute Ischemic StrokE
Low-Frequency REpetitive TRanscranial Magnetic Stimulation Combined With Endovascular Treatment in ACute Ischemic StrokE (RETRACE-II): A Randomized, Double-Blind, Sham-Controlled, Phase 2 Pilot Trial
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 24 Aug 2023
- Start date
- 25 May 2024
- Primary completion date
- 15 Apr 2025
- Lead sponsor
- Beijing Tiantan Hospital
- Diseases
- Stroke
- NCT number
- NCT06064747
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 25 May 2024 to the primary completion date, 15 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc.
- Before the bridging therapy, other thrombolytic drugs besides alteplase or tenecteplase were used;
- Participants in other clinical intervention studies within 30 days before randomization or who were participating in other clinical intervention studies.
Other illness
- Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders;
- Evidence of acute intracranial hemorrhage;
- A history of congenital or acquired hemorrhagic disease, coagulation factor deficiency, or thrombocytopenia disease;
- 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;
Lab values
- Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal or estimated glomerular filtration rate (EGFR) \< 60 mL/min;
Other
- 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);
- After blood pressure control, the systolic blood pressure was still ≥180 mmHg or the diastolic blood pressure was ≥110 mmHg;
- Patients during pregnancy or lactation and within 90 days of planned pregnancy;
Who the study is looking for
- 18 - 80 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;
- 6 ≤ NIHSS ≤ 25 before endovascular therapy;
- Signed informed consent from subjects or legally authorized representatives
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tian Tan Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.