Actively Recruiting

Phase Not Applicable
Age: 35Years - 75Years
All Genders
NCT05999318

pBFS-guided cTBS Over the Superior Temporal Gyrus for Aphasia After Ischemic Stroke

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

40

Participants Needed

2

Research Sites

145 weeks

Total Duration

On this page

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 Superior Temporal Gyrus (STG), guided by personalized Brain Function Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia.

CONDITIONS

Official Title

pBFS-guided cTBS Over the Superior Temporal Gyrus for Aphasia After Ischemic Stroke

Who Can Participate

Age: 35Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 35 and 75 years old (inclusive)
  • Diagnosed with acute ischemic stroke in the left hemisphere lasting from 15 days to 3 months
  • Diagnosed with aphasia using the Chinese version of the Western Aphasia Battery with an aphasia quotient below 93.8
  • First stroke occurrence
  • Normal language function before stroke and native Chinese speaker with at least 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 of 2 or higher
  • Aphasia caused by bilateral stroke, brain tumor, traumatic brain injury, Parkinson's disease, motor neuron disease, or other diseases
  • Implanted electronic devices such as pacemakers or cochlear implants, or MRI/TMS contraindications
  • History of epilepsy
  • Severe uncontrolled systemic diseases affecting heart, lungs, liver, kidneys confirmed by labs
  • Consciousness disorders with NIHSS 1(a) score of 1 or higher
  • Malignant hypertension
  • Severe organic diseases like malignant tumors with expected survival under 1 year
  • Severe hearing, visual, or cognitive impairments or inability to cooperate
  • Severe depression, anxiety, or mental illness preventing trial completion
  • Neuromodulation treatments within 3 months prior to enrollment
  • History of alcoholism, drug, or substance abuse
  • Other conditions judged unsuitable by researchers
  • Unable to complete follow-up due to location or other reasons
  • Women of childbearing age who are pregnant, breastfeeding, or planning pregnancy
  • Participation in other clinical trials

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

First Hospital of Jilin University

Changchun, China

Actively Recruiting

2

Shengjing Hospital of China Medical University

Shenyang, China

Actively Recruiting

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Research Team

N

Na Xu, PhD

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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