Actively Recruiting
Combined taVNS and tDCS in Subacute Stroke Patients
Led by National Cheng-Kung University Hospital · Updated on 2024-03-20
80
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ischemic stroke, the most prevalent neurological disorder, is treated with medication and thrombectomy but with limited success, especially in chronic stages where traditional rehabilitation is the primary option. Stroke often leads to post-stroke autonomic imbalance, deteriorating functional outcomes and increasing recurrence risk. Emerging non-pharmacological treatments like Transcutaneous Auricular Vagus Nerve Stimulation (VNS) and Focused Transcranial Direct Current Stimulation (tDCS) offer new possibilities. VNS targets post-stroke tissue injury and promotes healing and neurogenesis, while tDCS aims to enhance motor learning by rebalancing brain activity. Both therapies seek to improve outcomes in both acute and chronic stroke stages.
CONDITIONS
Official Title
Combined taVNS and tDCS in Subacute Stroke Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Subacute ischemic stroke patients within 7-30 days after stroke symptoms are stabilized
- Stroke confirmed by DWI-MRI
- Lesion involves at least the supratentorial area
- Unilateral weakness with manual muscle testing scale less than 4
- Stable vital signs and neurological condition
- Able to participate in regular rehabilitation programs
- Modified Rankin Scale less than 5
You will not qualify if you...
- National Institute of Health Stroke Scale score greater than 25 at study entry
- Presence of hemineglect
- Moderate-to-severe pain in any limb
- Unstable clinical condition
- Recurrent strokes or brainstem strokes
- Significant arrhythmia or cardiovascular complications
- Bradycardia (heart rate 50 bpm or less) or low blood pressure (SBP 100 mmHg or less or DBP 60 mmHg or less) at admission
- Evidence or suspicion of chronic conditions predisposing to intracranial hemorrhage
- Pre-existing coagulopathy with platelet count 100 or less, INR 3 or greater, or PTT 90 or greater
- Suspected infective endocarditis or stroke related to septic emboli
- Signs or symptoms of acute myocardial infarction
- Receiving other experimental therapies
- Suspected cerebral vasculitis or cranial dural arteriovenous fistula
- Cerebral venous thrombosis or significant brain swelling with midline shift
- History of left atrial myxoma
- Contraindications for VNS and tDCS including intracranial lesions, pacemaker, brain surgery history, active infection, metal implants, skin problems, substance abuse, epilepsy, hyperacusis, cognitive disturbances, pregnancy or nursing, use of neuropsychoactive drugs, psychiatric or neurological disease
- Not suitable for ECG recorders due to chronic disease or allergy to polyester
- Acute and severe patient condition
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Cheng Kung University Hospital
Tainan, Tainan, Taiwan, 71144
Actively Recruiting
Research Team
P
Pi-Shan Sung, MD,PhD
CONTACT
C
Chou-Ching Lin, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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