CompletedPhase 2

Lesion Network MApping Navigated Continuous Theta-burst STimulation for Motor REcovery in Acute Ischemic Stroke

China60 participantsStarted 2024-10-21

Plain-language summary

This is a multicenter, sham-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of lesion network mapping navigated cTBS in improving motor function in patients with acute ischemic stroke within 14 days of symptom onset.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age 18-80 years old.
✓. Acute ischemic stroke confirmed by CT or MRI at 14 days after onset.
✓. Pre-stroke modified Rankin scale (mRS) score≤1.
✓. 4≤NIHSS score≤ 25, 1a≤1, NIHSS5a/5b/6a/6b≥2 at least.
✓. Moderate or severe motor dysfunction (Fugl-Meyer motor score \< 80).
✓. Written informed consent from patients or their legally authorized representatives.

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;
✕. 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;

What they're measuring

Improvement of motor function

Timeframe: 7 days

Serious adverse events ( SAEs )

Timeframe: 7 days

Trial details

NCT IDNCT06400407

SponsorBeijing Tiantan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-27

View on ClinicalTrials.gov More Stroke, Acute Ischemic trials