Actively Recruiting

Phase Not Applicable
Age: 35Years - 75Years
All Genders
NCT05842304

Individualized Precision rTMS for Language Recovery in Patients After Ischemic Stroke: a Multi-center RCT

Led by Changping Laboratory · Updated on 2024-06-20

180

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The current multi-center study aims to evaluate the efficacy and safety of pBFS-guided rTMS Neuromodulation Treatment for the rehabilitation of language functions in ischemic stroke aphasic patients.

CONDITIONS

Official Title

Individualized Precision rTMS for Language Recovery in Patients After Ischemic Stroke: a Multi-center RCT

Who Can Participate

Age: 35Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 35 and 75 years, inclusive
  • Diagnosed with acute ischemic stroke according to 2019 American Heart Association/American Stroke Association Guidelines and 2018 Chinese Society of Neurology Guidelines
  • Stroke lesions located in the left hemisphere
  • Stroke occurred between 2 months and 1 year prior to enrollment
  • Diagnosed with aphasia per Chinese version of Western Aphasia Battery with aphasia quotient below 93.8
  • First stroke or previous stroke without significant residual effects (modified Rankin Scale score ≤1 before current stroke)
  • Normal language function before stroke with Mandarin as native language
  • Education level higher than primary school (more than 6 years)
  • Able to understand the trial and provide informed consent
Not Eligible

You will not qualify if you...

  • Severe dysarthria (NIHSS dysarthria score ≥2)
  • Aphasia caused by other conditions like brain tumor, Parkinson's syndrome, motor neuron disease, cerebral hemorrhage, traumatic brain injury
  • Contraindications for MRI or TMS such as claustrophobia, cardiac pacemaker, cochlear implant, metallic foreign bodies, or implanted electronic devices
  • History of epilepsy with at least 2 unprovoked seizures more than 24 hours apart, or seizures within past 12 months
  • Severe uncontrolled cardiac, pulmonary, hepatic, renal, or other systemic diseases
  • Disorders of consciousness (NIHSS 1(a) score ≥1)
  • Malignant hypertension with persistent blood pressure above 200/130 mmHg
  • Co-malignant neoplasm
  • Life expectancy less than 1 year from causes other than stroke
  • Deafness, visual impairment, or severe cognitive impairment preventing cooperation
  • Severe depression, anxiety, or other mental disorders preventing cooperation
  • Neuromodulation treatments (TMS or electrical stimulation) within past 3 months
  • History of alcohol, drug, or other substance abuse
  • Other test abnormalities judged unsuitable by investigator
  • Pregnant women or women planning pregnancy
  • Participation 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: 1 location

1

China Rehabilitation Research Center

Beijing, 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

2

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