Non-invasive transcutaneous stimulation of the vagus nerve and motor recovery after stroke
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
- 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)
Lieu de l’étude
Berne
(BASEC)
Sponsor
Universitätsklinik für Neurologie Inselspital
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Simon Jung
+41 31 632 30 83
simon.jung@clutterinsel.chUniversitäre Neurorehabilitation, Standorte Inselspital, Universitätsklinik Neurologie, Inselspital, 3010 Bern
(BASEC)
Informations scientifiques
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
04.08.2025
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
Non-invasive transcutaneous vagus nerve stimulation (tVNS) in acute stroke neurorehabilitation: Enhancing Motor Recovery and Cortical Repair (BASEC)
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Maladie en cours d'investigation
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Intervention étudiée
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