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NCT Number: NCT06639360

Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke

This is a multicenter, randomized, double-blind, sham-controlled trial, to determine the efficacy and safety of cTBS in treating patients with acute ischemic stroke after endovascular treatment.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with acute anterior circulation ischemic stroke aged between 18 and 80 years old.
  • Imaging suggests that the infarction is caused by occlusion of the terminal portion of the internal carotid artery or the M1/M2 segment of the middle cerebral artery.
  • A head CT within 24 hours of onset indicates an ASPECT score ≥6, and meets the guideline-recommended criteria for thrombectomy.
  • Pre-stroke mRS score is ≤1.
  • NIHSS score before thrombectomy is between 6 and 25.
  • With vascular recanalization of mTICI > 2b/3.
  • Informed consent form signed.

Exclusion criteria

  • Patients with contraindications to TMS treatment, such as those with metallic foreign objects in the head, pacemakers, implantable drug pumps, cochlear implants, etc.;
  • Patients with epilepsy, increased intracranial pressure, tumors, acute cerebral hemorrhage, or other severe neurological diseases, and those with severe functional impairment of organs such as the heart, liver, and kidneys;
  • Head CT/MRI indicates midline shift or significant mass effect, or patients planned for surgical intervention;
  • Head CT/MRI suggests acute cerebral infarction in both sides;
  • Patients who are pregnant or breastfeeding;
  • Patients with severe mental disorders or dementia who cannot cooperate with follow-up;
  • Patients with other severe diseases resulting in an expected survival of less than 90 days;
  • Patients who are participating in other interventional clinical studies within 30 days before the start of this study or after the onset of this condition;
  • Patients who cannot cooperate with informed consent.

Treatment and study plan

Transcranial Magnetic Stimulation Active

Device

The patients will be treated with cTBS and usual medical treatment after endovascular treatment

Transcranial Magnetic Stimulation Sham

Device

The patients will be treated with sham-cTBS and usual medical treatment after endovascular treatment

Primary outcomes

  1. Changes of infarct volumes from baseline to Day 5

    Time frame: 5 days after enrollment

  2. Death

    Time frame: The first 5 days after enrollment

  3. NIHSS at Day 5

    Time frame: 5 days after enrollment

Secondary outcomes

  1. Early neurological deterioration

    Time frame: 3 days after enrollment

    proportion of patients with an increase of ≥4 points in NIHSS at 3 days

  2. Final infarct volume

    Time frame: 5 days after enrollment

    The infarct volume on DWI at 5 days

  3. Intracranial hemorrhage incidence

    Time frame: 24h after enrollment

  4. Proportion of patients with symptomatic intracranial hemorrhage

    Time frame: 90 days after enrollment

  5. Proportion of patients with mRS 0-2

    Time frame: 90 days after enrollment

  6. Barthel Index score

    Time frame: 90 days after enrollment

  7. Stroke recurrence

    Time frame: 90 days after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Jingjing Zhao, Dr.

CONTACT

[email protected]

+86-29-84775365

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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