Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
China Rehabilitation Research Center
Beijing, China
Actively Recruiting
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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