Combining two non-drug therapies for patients recovering from ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of combined Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) and Transcranial Direct Current Stimulation (tDCS) on patients who have experienced a subacute ischemic stroke. The study aims to enhance recovery by targeting post-stroke tissue injury and improving motor learning through neuromodulation techniques. Participants will receive either active or sham stimulation to assess the efficacy of these non-pharmacological treatments in improving functional outcomes. The trial focuses on patients within 7-30 days post-stroke, utilizing specific inclusion and exclusion criteria to ensure appropriate candidate selection.

Why it matters

Who can join: the full rules

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

Where it's running

• National Cheng Kung University Hospital
  Tainan, Tainan, Taiwan Recruiting

Study contacts

• Study coordinator: Pi-Shan Sung, MD,PhD
• Email: pishansung@gmail.com
• Phone: +886-62353535

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.