Actively Recruiting

Phase Not Applicable
Age: 35Years - 75Years
All Genders
NCT05907031

pBFS-guided cTBS Over the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke

Led by Changping Laboratory · Updated on 2025-04-04

30

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

Sponsors

C

Changping Laboratory

Lead Sponsor

F

First Affiliated Hospital of Fujian Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The objective of this trial is to evaluate the effectiveness and safeness of continuous Theta Burst Stimulation (cTBS) over the right Inferior Frontal Gyrus (IFG), guided by personalized Brain Functional Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia.

CONDITIONS

Official Title

pBFS-guided cTBS Over the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke

Who Can Participate

Age: 35Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients between the ages of 35 and 75 years (including 35 and 75 years).
  • Diagnosed with acute ischemic stroke according to 2019 AHA/ASA and 2018 Chinese Society of Neurology guidelines.
  • Stroke lesions located in the left hemisphere.
  • Stroke onset between 15 days and 3 months prior to enrollment.
  • Diagnosed with aphasia with a Western Aphasia Battery aphasia quotient less than 93.8.
  • First onset of stroke.
  • Normal language function before stroke, native Mandarin speakers with more than 6 years of education.
  • Able to understand the trial and provide informed consent.
Not Eligible

You will not qualify if you...

  • Severe dysarthria with NIHSS item 10 score ≥ 2 points.
  • Aphasia caused by bilateral hemispheric stroke, brain tumors, traumatic brain injury, Parkinson's disease, motor neuron disease, or other diseases.
  • Implanted electronic devices like pacemakers or cochlear implants, metal foreign bodies, or MRI/TMS contraindications.
  • History of epilepsy.
  • Severe systemic diseases (heart, lung, liver, kidney) uncontrolled by medications.
  • Impaired consciousness with NIHSS item 1(a) score ≥ 1 point.
  • Malignant hypertension.
  • Malignant tumors.
  • Life expectancy less than 1 year due to causes other than stroke.
  • Severe hearing, visual, or cognitive impairments preventing trial completion.
  • Severe depression, anxiety, or other mental illness preventing trial completion.
  • Received neuroregulatory treatments such as TMS or transcranial electrical stimulation within 3 months before enrollment.
  • History of alcohol, drug, or other substance abuse.
  • Other abnormal test results deemed unsuitable by researchers.
  • Women of childbearing age who are pregnant or planning pregnancy.
  • Participation in other clinical trials.

AI-Screening

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Actively Recruiting

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Research Team

J

Jianting Huang, MD,PhD

CONTACT

R

Ruiqi Pan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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