NCT07645586

Brief Summary

This Phase 3 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 whether this personalized brain stimulation approach improves functional recovery and is safe for patients after ischemic stroke.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
584

participants targeted

Target at P75+ for phase_3

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 9, 2026

Last Update Submit

June 9, 2026

Conditions

Ischemic Stroke

Keywords

ishchemic strokeLesion network mappingContinuous theta-burst stimulationMotor functionNeuronavigation

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients achieving mRS 0-2

    Day 90 post-randomization

  • Proportion experiencing serious adverse events (SAEs)

    Proportion experiencing serious adverse events (SAEs), including seizures

    Within 90 days post-randomization

Secondary Outcomes (13)

  • Distribution shift in mRS scores

    Day 90 post-randomization

  • Proportion of patients achieving mRS 0-1

    Day 90 post-randomization

  • National Institutes of Health Stroke Scale (NIHSS) total score

    Day 7 post-randomization

  • Fugl-Meyer Assessment (FMA) score

    Day 7 post-randomization

  • Barthel Index of Activities of Daily Living score

    Day 90 post-randomization

  • +8 more secondary outcomes

Study Arms (2)

LNM-navigated cTBS group

EXPERIMENTAL

Participants receive active lesion network mapping (LNM)-navigated continuous theta burst stimulation (cTBS).

Device: LNM-navigated cTBS

Sham cTBS group

SHAM COMPARATOR

Participants receive sham LNM-navigated cTBS using procedures that mimic the active intervention.

Device: Sham cTBS

Interventions

LNM-navigated cTBSDEVICE

Individualized treatment targets are defined by outlining each patient's acute infarct lesion on MRI and projecting it onto a normative functional connectivity map to identify symptom-relevant network nodes within sensorimotor regions. Treatment is delivered over seven consecutive days using a figure-8 coil guided by neuronavigation. cTBS consists of 3-pulse bursts at 50 Hz, repeated at 5 Hz, for a total of 600 pulses over 40 seconds, delivered at 80% of the resting motor threshold (RMT).

LNM-navigated cTBS group
Sham cTBSDEVICE

Sham stimulation follows the same MRI-based lesion mapping, target selection, neuronavigation workflow, coil positioning, timing, acoustic noise, and treatment course as the active group, but uses a sham figure-8 coil that mimics stimulation without generating a significant magnetic field. This design helps maintain blinding of participants and assessors while ensuring that no effective magnetic stimulation is delivered.

Sham cTBS group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • NIH Stroke Scale (NIHSS) total score 6-25, with item 1a ≤ 1 point, and at least one of items 5a, 5b, 6a, or 6b ≥ 2 points.
  • Written informed consent signed by the patient or the patient's legally authorized representative.

You may not qualify if:

  • 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).
  • Evidence of acute intracranial hemorrhage, including spontaneous intracerebral hemorrhage, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage.
  • Pre-stroke mRS ≥ 2.
  • Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg despite antihypertensive treatment.
  • Pregnant or breastfeeding women, or women planning pregnancy within 90 days.
  • Severe psychiatric disorders or dementia (or other conditions) precluding informed consent or follow-up.
  • Concomitant malignant tumor or severe systemic disease with life expectancy \< 90 days.
  • Participation in any other interventional clinical study within 30 days before randomization, or currently enrolled in such a study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

Location

Related Publications (1)

  • Ding L, Liu H, Jing J, Jiang Y, Meng X, Chen Y, Zhao X, Niu H, Liu T, Wang Y, Li Z. Lesion Network Mapping for Neurological Deficit in Acute Ischemic Stroke. Ann Neurol. 2023 Sep;94(3):572-584. doi: 10.1002/ana.26721. Epub 2023 Jun 27.

    PMID: 37314250RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Lingling Ding, MD

CONTACT

008613552358752dinglingling@bjtth.org

Zixiao Li, MD

CONTACT

lizixiao2008@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, care providers, investigators, and outcomes assessors are all blinded to treatment allocation. A separate, unblinded technician prepares and operates the stimulation device according to randomized codes but has no role in clinical assessments, data collection, or patient care beyond administering the sessions. Treatment codes remain concealed until database lock, except in predefined emergencies requiring unblinding for safety.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 12, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)