tDCS stimulation: tDCS 1mA will be applied for 20min. tDCS will be applied around the infract area. taVNS or sham taVNS wil be applied before tDCS. The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks.
taVNS stimulation: taVNS will be applied for 30 min. The electrode will be placed on the left ear of the patient. The amplitude of taVNS will be adjusted under the patient's pain threshold. After taVNS, tDCS will be applied for 20 min. The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks.
sham tDCS stimulation: sham tDCS 1mA will be applied for 20min. sham tDCS will be applied around the infract area. The stimulation will be applied for only 10 seconds and no stimulation afterward. taVNS or sham taVNS wil be applied before sham tDCS.The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks.
sham taVNS stimulation: sham taVNS will be applied for 30 min. The electrode will be placed on the left ear of the patient. The amplitude of sham taVNS will be adjusted under the patient's pain threshold. The stimulation was only applied for 5 seconds and no stimulation afterward. After sham taVNS, tDCS or sham tDCS will be applied for 20 min. The intervention will be applied before physical therapy. A total of 10 sections are applied during the intervention period of 2 weeks.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years old
* Subacute ischemic stroke patients within 7-30 days after stroke symptoms is stabilized
* Stroke will be documented by DWI-MRI
* Lesion locations at least involve supratentorial area
* Patients have unilateral weakness documented with manual muscle testing scales less than 4
* Stable vital signs and stable neurological signs
* Able to receive regular rehabilitation programs, and 8) modified Rankin Scales (mRS) less than 5.
Exclusion Criteria:
* A National Institute of Health Stroke Scale (NIHSS) score \> 25 at study entry
* The presence of hemineglect
* Moderate-to-severe pain in any limb
* Unstable clinical condition
* Recurrent strokes or brainstem strokes
* Marked arrhythmia or cardiovascular complications
* Bradycardia (HR≤50 bpm) or low blood pressure (SBP≤100 mmHg or DBP≤60mmHg) at admission
* Patients with radiographic evidence or suspicion of chronic conditions that may predispose them to intracranial hemorrhage including brain arteriovenous malformations, cerebral cavernous malformations, cerebral telangiectasia, multiple previous intracerebral hemorrhages (amyloid angiopathy)
* Pre-existing coagulopathy, consist of platelet count of ≤100, INR≥ 3, PTT≥ 90
* Patients suspected of having infective endocarditis and ischemic stroke related to septic emboli
* Signs or symptoms of acute myocardial infarction, including EKG findings
* Concomitant experimental therapy
* Suspected cerebral vasculitis based on medical history and CTA/Magnetic Resonance Angiogram (MRA)
* Suspected cranial dural arteriovenous fistula, and evidence of dissection in the intracranial cerebral arteries
* Cerebral venous thrombosis and significant mass effect with midline shift
* History of left atrial myxoma
* Presence of contraindication for VNS (TENS) and tDCS: (A) Intracranial space occupied lesion, (B) Presence of a pacemaker, (C) History of brain neurosurgery, (D) Active CNS or systemic infection, (E) Presence of a metallic foreign body implant, (F) Skin abnormalities, (G) History of alcohol/drug abuse, (H) Epilepsy/History of epilepsy at family (I) Hyperacusis, (J) Cognitive/Consciousness disturbance, (K) Pregnancy or nursing females, (L) Use of neuropsycoactive drugs, (M) Psychiatric/ Neurologic disease
* Not suitable for equipping ECG recorders: (A) Chronic disease, and allergic to polyester, (B) Acute and severe patients
Primary outcome measure(s)
Disability Severity Assessment Using the Modified Rankin Scale (mRS) — 0, 4, 12 week * Description: The Modified Rankin Scale (mRS) is a widely used 6-point disability scale evaluating the degree of disability or dependence in daily activities of people who have suffered a stroke.
* Scale Range: 0 (no symptoms) to 5 (severe disability).
* Score Interpretation: Higher scores indicate a worse outcome, reflecting increased disability.
Motor Function Assessment Using Fugl-Meyer Assessment (FMA) for Upper Extremity (UE) and Lower Extremity (LE) — 0, 4, 12 week * Description: The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. It evaluates the motor recovery post-stroke, focusing on voluntary movements and joint functions.
* Scale Range:
Upper Extremity (UE): 0 to 66 Lower Extremity (LE): 0 to 34
* Score Interpretation: Higher scores indicate better motor functioning, reflecting greater voluntary movement capability and reduced impairment.
Upper Limb Motor Function Evaluation Using the Wolf Motor Function Test (WMFT) — 0, 4, 12 week * Description: The WMFT is designed to assess motor ability through timed and functional tasks in individuals with upper extremity motor impairment.
* Scale Range:
Timed Tasks: Seconds to complete, up to 120 seconds per task. Functional Tasks: Scored 0 to 5 on functional ability.
* Score Interpretation:
Timed Tasks: Lower completion times indicate better motor function. Functional Tasks: Higher scores represent greater functional ability and more normal movement patterns.
Mobility and Balance Assessment Using the Time Up and Go Test (TUG) — 0, 4, 12 week * Description: The TUG test measures the time taken by an individual to stand up from a seated position, walk a short distance, turn around, walk back, and sit down.
* Scale Range: Time in seconds.
* Score Interpretation: Lower times indicate better mobility and balance.
Trial sites (1)
Facility
City
Region
Status
National Cheng Kung University Hospital
Tainan
Tainan
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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