Actively Recruiting

Phase Not Applicable
Age: 35Years - 75Years
All Genders
NCT05969548

pBFS-guided cTBS at Different Doses for Aphasia After Stroke

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

60

Participants Needed

2

Research Sites

117 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 different doses of continuous Theta Burst Stimulation (cTBS) over the right Superior Frontal Gyrus (SFG), guided by personalized Brain Function Sector (pBFS) technology, on language function recovery in patients with post-stroke aphasia.

CONDITIONS

Official Title

pBFS-guided cTBS at Different Doses for Aphasia After 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 ischemic or hemorrhagic stroke with lesions in the left hemisphere, with illness duration from 15 days to 6 months
  • Diagnosed with aphasia by the Chinese version of Western Aphasia Battery with aphasia quotient below 93.8 points
  • First stroke occurrence
  • Normal language function before stroke and native Chinese speaker with at least 6 years of education
  • Understands the trial and has signed informed consent
Not Eligible

You will not qualify if you...

  • Combined dysarthria with NIHSS item 10 score of 2 or higher
  • Aphasia caused by bilateral hemisphere 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, etc.
  • Consciousness disorders with NIHSS 1(a) score of 1 or higher
  • Malignant hypertension
  • Severe organic diseases like malignant tumors with expected survival less than 1 year
  • Severe hearing, visual, or cognitive impairment or inability to cooperate
  • Severe depression, anxiety, or mental illnesses preventing trial completion
  • Neuromodulation treatments like TMS or transcranial electric stimulation in past 3 months
  • History of alcoholism, drug, or other substance abuse
  • Other abnormalities deemed unsuitable by researchers
  • Inability to complete follow-up due to geographic or other reasons
  • Women who are pregnant, breastfeeding, or planning pregnancy during trial
  • Currently participating in other clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Nanshi Hospital of Nanyang

Nanyang, Henan, China

Actively Recruiting

2

The fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Actively Recruiting

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Research Team

R

Ruiqi Pan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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pBFS-guided cTBS at Different Doses for Aphasia After Stroke | DecenTrialz