NCT06822140

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Rheinburg-Klinik · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study participants will undergo pre-evaluation and receive information within the first 7 days after admission to the Rheinburg-Klinik (Visit 0). During these 7 days, study participants will be randomly (1:1) allocated to the intervention group (taVNS) or control group (sham-stimulation) and will be clinically examined (Visit 1). At Visit 2 (≤7 days after admission), baseline assessments will be performed. During the intervention period, (week 2 to 6 after admission), either taVNS or sham-stimulation will be conducted for 30 minutes per day at 5 days per week for 5 weeks, paired with cognitive and motor training. Participants will be blinded to treatment. Standardized rehabilitation measures according to the clinic standards will be performed in both groups during the study period. All study participants will be monitored by recording an ECG during intervention/sham-stimulation. Before and after intervention/sham-stimulation an EEG will be conducted. After intervention, i.e., at the end of week 6, the same assessments as at baseline will be repeated (Visit 3). A follow up visit will take place 6 months after intervention.

Conditions

• Ischemic Stroke
• Motor Deficits
• Cognitive Impairment
• Vagus Nerve Stimulation

Interventions

Type	Name	Description
DEVICE	transcutaneous auricular vagus nerve stimulation	Stimulation parameters: * Stimulating side: ipsilateral to the infarcted brain hemisphere * Location of pStimulation: Cymba conchae * Impulse shape: bi-phasic * Impulse intensity: at least 0.5 mA (max. 2.0 mA). * Impulse duration: 28 sec on, 32 sec off * Impulse frequency: 20-30 Hz.
DEVICE	sham-stimulation	An electrode is only attached to the ear without applying electrical impulses.

Timeline

• Start date: 2025-04-01
• Primary completion: 2028-02-29
• Completion: 2028-04-30
• First posted: 2025-02-12
• Last updated: 2025-02-19

Locations

1 site across 1 country: Switzerland