Stimulation du nerf vague trans-auriculaire (taVNS) et entraînement robotique pour bras paralysé après un AVC (VaNSaRTS)
Évaluation de l'utilisation de la stimulation transauriculaire du nerf vague (taVNS) et de l'entraînement robotique pour améliorer la récupération motrice des membres supérieurs après un AVC
To determine whether treatment with transauricular vagus nerve stimulation (taVNS) during the training of an affected upper limb of a patient with chronic stroke on a robotic motor task alters the motor impairment.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The investigators will evaluate whether transauricular vagus nerve stimulation (taVNS) delivered during extensor movements executed on a robotic device will alter the clinical measurement of upper limb motor performance in 45 patients with chronic stroke.
Patients will engage the robot first with their unaffected limb. This practice will ensure understanding and serve to activate the hemisphere ipsilateral to the impaired limb. Patients are likely to perform this activity quickly, there will not be any taVNS during this part of the procedure. Patients will then wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
New York
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Manhasset, New York, États-Unis, 11030
- Feinstein Institutes at Northwell Health
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- In receipt of full vaccination status and no recent upper respiratory symptoms and no loss of taste or olfaction.
- Individuals between 18 and 85 years of age
- First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
- Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI)
- Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist).
Exclusion Criteria:
- Recent fever or upper respiratory symptoms.
- Botox treatment within 3 months of enrollment
- Fixed contraction deformity in the affected limb
- Complete and total flaccid paralysis of all shoulder and elbow motor performance
- Prior injury to the vagus nerve
- Severe dysphagia
- Introduction of any new rehabilitation interventions during study
- Individuals with scar tissue, broken skin, or irremovable metal piercings that may interfere with the stimulation or the stimulation device
- Highly conductive metal in any part of the body, including metal injury to the eye; this will be reviewed on a case by case basis for PI to make a determination
- Pregnant or plan on becoming pregnant or breastfeeding during the study period
- Significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and A-V blocks (enrollment to be determined by PI review)
- Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur factice: Affected Limb
Patients will wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement. Within subject. Sham controlled. Double blind, the patient will not know whether they are receiving taVNS, all patients feel a ramp up current but only the active group will receive timed stimulation bursts during the robotic protocol that engages the affected limb. ' |
Patients will wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement. |
|
Aucune intervention: Unaffected limb
Patients will engage the robot first with their unaffected limb. This practice will ensure understanding and serve to activate the hemisphere ipsilateral to the impaired limb. Patients are likely to perform this activity quickly, there will not be any taVNS during this part of the procedure. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fugl-Meyer Motor Scale for the upper extremity
Délai: 30-45minutes
|
A standard well characterized measure of the movement ability of the subjects arm- shoulder, elbow, wrist, hand and fingers. |
30-45minutes
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Action Research Arm Test (ARAT)
Délai: 30-45minutes
|
A standard evaluation of 19 different real world actions of the arm, including movements around the shoulder, elbow, wrist, hand and fingers. |
30-45minutes
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Bruce T Volpe, MD, Feinstein Center for Molecular Medicine
- Directeur d'études: Timir Datta Chaudhuri, PhD, Feinstein Center for Bioelectronic Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 21-1355
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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