A Phase 2b Trial of Lesion Network Mapping-Guided cTBS for Motor Recovery After Acute Ischemic Stroke

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital

About this trial

This Phase 2b study will evaluate whether lesion network mapping-guided continuous theta burst stimulation (cTBS) can improve recovery after acute ischemic stroke. The treatment uses each participant's brain imaging to identify individualized stimulation targets related to stroke symptoms. Participants will receive either active cTBS or a sham procedure in addition to standard stroke care. The study will assess the efficacy and safety of this personalized brain stimulation approach and support planning for future confirmatory trials.

Eligibility criteria

Qualifiers

Age 18-80 years.

Ischemic stroke onset within the past 14 days.

Unilateral, supratentorial ischemic stroke confirmed by CT or MRI.

Pre-stroke modified Rankin Scale (mRS) score of 0-1.

Disqualifiers

Contraindications to TMS (e.g. cranial metallic foreign bodies, cardiac pacemaker, implanted drug pump, cochlear implant).

History of epilepsy or seizure, intracranial hypertension, tumor, or other serious neurological disease.

Midline shift or parenchymal mass effect on cranial CT or other imaging.

CT or MRI evidence of bilateral acute cerebral infarction or infratentorial acute infarction (brainstem or cerebellum).

Trial design

Treatments tested in this trial

  • LNM-navigated cTBS
  • Sham cTBS

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators