NCT06822140Not yet recruiting

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

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Motor and Cognitive Deficits After Ischemic Stroke

Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Study type: Interventional
Enrollment: 144 (estimated)
First submitted: 5 Feb 2025
Start date: 1 Apr 2025
Primary completion date: 29 Feb 2028
Lead sponsor: Rheinburg-Klinik
Diseases: Stroke
NCT number: NCT06822140

What you commit to

Study type: Interventional
Planned participants: 144
From 1 Apr 2025 to the primary completion date, 29 Feb 2028
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

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

Other illness

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

Age \< 18 years

Other

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

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Rheinburg Klinik Coordinator of this site? Confirm its status	Walzenenhausen	Switzerland	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.