Tests ear-based nerve stimulation for movement and thinking after stroke
Tests ear-based vagus nerve stimulation in adults recovering from ischemic stroke.
Plain-language title generated from the registry record
Registry title: Effect of Vagus Nerve Stimulation Via the Outer Ear on Motor and Cognitive Deficits After Ischemic Stroke
Key facts
- Where
- Walzenenhausen, SwitzerlandSee the site
Where in Switzerland
- Rheinburg KlinikWalzenenhausen, SwitzerlandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rheinburg-Klinik
- Trial code
- NCT06822140
- Record updated
- 19 February 2025
- Original description
The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) works to treat motor and neurocognitive deficits after ischemic stroke when applied within 30 days after onset of stroke.Read full original descriptionShow less
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Motor and Cognitive Deficits After Ischemic Stroke
The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) works to treat motor and neurocognitive deficits after ischemic stroke when applied within 30 days after onset of stroke.
The main questions it aims to answer are:
* Does tVNS improve motor deficits measured by the Fugl-Mayer assessment after ischemic stroke? * Does tVNS ameliorate stroke-related cognitive impairment? Researchers will compare tVNS to a placebo (sham stimulation, i.e. an electrode is fixed on the ear without applying electrical impulses ) to see if tVNS works to treat motor and cognitive deficits after stroke .
Participants will:
* Receive tVNS or sham stimulation for 30 minutes 5 days a week during 5 weeks after ischemic stroke * Receive smotor and cognitive training during the tVNS or sham stimulation * Will take part on a standardized stroke rehabilitation program during the 5 weeks in a rehabilitation clinic.
Inclusion: 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: 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); 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; Alcohol and drug abuse; Patients receiving any therapy (medication or otherwise) at study entry that would interfere with VNS; Documented history of dementia before index stroke; Primary intracranial hematoma or subarachnoid hemorrhage; Low heart rate (< 60 bpm); Active post-stroke delirium, unable to cooperate; Type 1 and 2 diabetes mellitus; Age < 18 years; Pregnant and breastfeeding women; Severe aphasia (i.e. unable to follow two-stage-commands); Pre-existing hemiparesis; Severe vision and hearing problems; Sore and diseased skin of the auricle.