NCT06244914Recruiting
Combined taVNS and tDCS in Subacute Stroke Patients
Combining Closed-loop Transcutaneous Auricular Vagus Nerve Stimulation and Focal Transcranial Direct Current Stimulation as an Adjuvant Treatment for Acute and Subacute Strokes
Source: ClinicalTrials.gov · Last updated 20 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 4 Jan 2024
- Start date
- 15 Feb 2024
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- National Cheng-Kung University Hospital
- Diseases
- Stroke
- NCT number
- NCT06244914
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 15 Feb 2024 to the primary completion date, 30 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Concomitant experimental therapy
Other illness
- A National Institute of Health Stroke Scale (NIHSS) score \> 25 at study entry
- Unstable clinical condition
- Marked arrhythmia or cardiovascular complications
- Patients suspected of having infective endocarditis and ischemic stroke related to septic emboli
- Signs or symptoms of acute myocardial infarction, including EKG findings
- 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
Lab values
- Pre-existing coagulopathy, consist of platelet count of ≤100, INR≥ 3, PTT≥ 90
Other
- The presence of hemineglect
- Moderate-to-severe pain in any limb
- Recurrent strokes or brainstem strokes
- Bradycardia (HR≤50 bpm) or low blood pressure (SBP≤100 mmHg or DBP≤60mmHg) at admission
- Suspected cerebral vasculitis based on medical history and CTA/Magnetic Resonance Angiogram (MRA)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.