Cervical tsDCS on Stroke Patients (AMPLI-MOV)
Clinical and Neurophysiological Evaluation of the Effects of Cervical tsDCS on Stroke Patients With Distal Upper Limb Strength Deficit
The present project aims to evaluate the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fabrizio Vecchio
- Numéro de téléphone: 3478031201
- E-mail: fabrizio.vecchio@sanraffaele.it
Lieux d'étude
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RM
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Roma, RM, Italie, 00166
- Recrutement
- IRCCS San Raffaele Roma
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Contact:
- Fabrizio Vecchio
- Numéro de téléphone: +39-06-52253767
- E-mail: fabrizio.vecchio@sanraffaele.it
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Rome
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Rome, Rome, Italie, 00163
- Pas encore de recrutement
- IRCCS San Raffaele Roma
-
Contact:
- Fabrizio v
- Numéro de téléphone: 3478031201
- E-mail: fabrizio.vecchio@sanraffaele.it
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Group Stroke:
Inclusion criteria:
- age over 18 years;
- first ischemic/hemorrhagic stroke (within 30 days of onset);
- mild-to-moderate stroke (NIHSS scale score<16).
- residual function of the upper limb, assessed by the following scales: - MRC of the distal muscles of the upper limb: score between 2 and 4; - NHISS (items 5A and 5B): score between 1 and 3;
- ability to give informed consent and understand instructions.
Exclusion criteria:
- severe spasticity (Ashworth Scale score > 2);
- severe aphasia;
- severe neglect;
- history of disabling neurological disease;
- history of epilepsy;
- significant comorbidities;
- contraindications to tsDCS.
Healthy Group:
Inclusion criteria:
- age over 18 years;
- equalized in age with the patient group.
Exclusion criteria:
- history of stroke progress;
- history of severe neurological disease.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: En bonne santé
|
Transcranial direct current stimulation |
|
Expérimental: Accident vasculaire cérébral
|
Transcranial direct current stimulation |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
improvement of paretic hand performance
Délai: through study completion, an average of 1 year
|
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during Reaching |
through study completion, an average of 1 year
|
|
improvement of paretic hand performance
Délai: through study completion, an average of 1 year
|
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during Grasping |
through study completion, an average of 1 year
|
|
improvement of paretic hand performance
Délai: through study completion, an average of 1 year
|
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during Lifting test |
through study completion, an average of 1 year
|
|
improvement of paretic hand performance
Délai: through study completion, an average of 1 year
|
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level duringthe Nine Hole Peg test |
through study completion, an average of 1 year
|
|
improvement of paretic hand performance
Délai: through study completion, an average of 1 year
|
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during finger mobility tests |
through study completion, an average of 1 year
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RP 23/06
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
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