Non-invasive transcutaneous stimulation of the vagus nerve and motor recovery after stroke
Summary description of the study
Stroke is one of the leading causes of permanent disabilities in Western countries. As a result of a stroke, there are restrictions on the movement of the arm on the side opposite to the brain lesion. Stroke is typically treated with physical therapy, which includes physiotherapy and occupational therapy. Opportunities to improve motor recovery after a stroke are currently the subject of intensive research. Previous studies in humans have shown that non-invasive transcutaneous vagus nerve stimulation (tVNS) can improve motor recovery of the arm after a stroke. However, in all these studies, tVNS was applied to outpatient patients who had suffered a stroke 12 weeks or longer before the intervention. Therefore, we do not know what effects tVNS has when applied shortly after a stroke. Our brain has the ability to reorganize itself after a stroke. This process is called neuroplasticity. Since neuroplasticity is highest in the acute phase after a stroke (within 4 weeks), we want to investigate whether the application of tVNS in the acute phase after a stroke can improve the recovery of motor functions of the upper extremities.
(BASEC)
Intervention under investigation
The intervention being studied is called transcutaneous vagus nerve stimulation (tVNS). The idea behind tVNS is that since the vagus nerve innervates certain regions of the ear, stimulating these regions with low electrical currents can lead to stimulation of the vagus nerve. The small electrical currents are delivered through an electrode that is simply attached to the ear region.
(BASEC)
Disease under investigation
Stroke
(BASEC)
- At least 18 years old - Ischemic stroke - Onset of stroke ≤ 4 weeks - Impaired hand movement, measured with a Fugl-Meyer score (standard test for measuring hand movement ability after stroke) between 15 and 45) - Ability to provide informed consent - Ability to follow the protocol instructions (BASEC)
Exclusion criteria
- Second stroke during rehabilitation - Delirium or impaired attention - Inability to follow treatment sessions - Severe language comprehension deficits - Severe dystonia (i.e., disturbance of normal muscle tone) or spasticity (i.e., increased muscle tone) - Severe other diagnoses (e.g., traumatic, rheumatological, neurodegenerative diseases) - Pregnant - Patients/subjects with pacemakers - Skull fracture - History of epilepsy - Patient/project with metallic objects in the brain (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
Universitätsklinik für Neurologie Inselspital
(BASEC)
Contact
Contact Person Switzerland
Simon Jung
+41 31 632 30 83
simon.jung@clutterinsel.chUniversitäre Neurorehabilitation, Standorte Inselspital, Universitätsklinik Neurologie, Inselspital, 3010 Bern
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
04.08.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Non-invasive transcutaneous vagus nerve stimulation (tVNS) in acute stroke neurorehabilitation: Enhancing Motor Recovery and Cortical Repair (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available