Effect of Vagus Nerve Stimulation Via the Outer Ear on Motor and Cognitive Deficits After Ischemic Stroke

Launched by RHEINBURG-KLINIK · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called transcutaneous auricular vagus nerve stimulation (taVNS) to see if it can help people recover from motor and cognitive difficulties that can occur after an ischemic stroke. An ischemic stroke happens when a blood clot blocks blood flow to the brain. The researchers want to find out if taVNS, which involves applying gentle electrical stimulation to the outer ear, can improve movement and thinking abilities when started within 30 days after a stroke. Participants will receive either the taVNS treatment or a placebo (a treatment that looks the same but doesn’t provide any real stimulation) for 30 minutes a day, five days a week, for five weeks. They will also take part in rehabilitation exercises to help improve their skills.

To be eligible for this trial, participants must have had their first stroke within the last 15 to 30 days, have some movement and cognitive difficulties, and be right-handed. They also need to be able to participate in rehabilitation therapy. However, certain individuals, such as those under 18, pregnant women, or those with specific medical conditions, may not qualify. This study is not yet recruiting participants but aims to provide valuable insights into how taVNS can support recovery after a stroke.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Onset of stroke ≥15 days and ≤30 days after randomization
• • Ischemic stroke in the anterior cerebral circulation detected by MR imaging or computer tomography
• • National Institutes of Health Stroke Scale (NIHSS) score ≥3 points
• • Montreal Cognitive Assessment (MoCA) score ≤ 26 points
• • First ever stroke
• • Right-handed
• • Ability to participate in a standardized rehabilitation therapy
• • Written informed consent signed by the subject or next kin
• Exclusion Criteria:
• • Age \< 18 years
• • Pregnant and breastfeeding women
• • Severe concomitant neurological (brain tumor, encephalitis, Parkinson disease, epilepsy prior to stroke onset) or mental disorders (psychiatric conditions such as schizophrenia, uncontrolled depression or bipolar disorder before stroke onset)
• • Severe aphasia (i.e. unable to follow two-stage-commands)
• • Pre-existing hemiparesis
• • Documented history of dementia before index stroke
• • Primary intracranial hematoma or subarachnoid hemorrhage
• • Active implantable medical device (e.g., pacemaker, deep brain stimulator, cochlear implants, cerebral shunts)
• • Metal cervical spine hardware or metallic implant near the stimulation site
• • Modified Rankin scale (mRS) ≥ 2 prior to stroke onset
• • Low heart rate (\< 60 bpm)
• • Severe vision and hearing problems
• • Alcohol and drug abuse
• • Active post-stroke delirium, unable to cooperate
• • Type 1 and 2 diabetes mellitus
• • Sore and diseased skin of the auricle
• • Patients receiving any therapy (medication or otherwise) at study entry that would interfere with VNS