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RECRUITING

NCT06244914

Combined taVNS and tDCS in Subacute Stroke Patients

Sponsor: National Cheng-Kung University Hospital

View on ClinicalTrials.gov

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.

Official title: Combining Closed-loop Transcutaneous Auricular Vagus Nerve Stimulation and Focal Transcranial Direct Current Stimulation as an Adjuvant Treatment for Acute and Subacute Strokes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-02-15

Completion Date

2027-04-30

Last Updated

2024-03-20

Healthy Volunteers

Conditions

Ischemic Stroke

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

DEVICE

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.

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

Locations (1)

National Cheng Kung University Hospital

Tainan, Tainan, Taiwan

Clinical Research Directory

Combined taVNS and tDCS in Subacute Stroke Patients

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)