Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Hemiparesis
Optimizing Transcranial Direct Current Stimulation for Motor Recovery From Severe Post-stroke Hemiparesis
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study has 2 aims: 1) determine which transcranial direct current stimulation (tDCS) electrode configuration is most effective in combination with motor training to promote motor recovery from severe post-stroke hemiparesis; and 2) begin to clarify the extent to which baseline transcranial magnetic stimulation (TMS) measures predict response to tDCS, as well as the effects of tDCS paired with motor training on TMS measures of motor cortical organization.
To accomplish these aims, the investigators will recruit 36 human subjects with severe post-stroke hemiparesis and assign each subject to 1 of 4 tDCS conditions (anodal excitatory ipsilesional; cathodal inhibitory contralesional; a combination of anodal excitatory ipsilesional during cathodal inhibitory contralesional; or sham). Each subject will undergo a 20-minute stimulation session once a day for 10 days over a 2-week period. Each session will be followed by 3 hours of intensive, task-oriented upper extremity motor training.
Outcome measures for this study include TMS motor cortical maps and standardized tests of motor performance. The investigators hypothesize that all groups will show improvement in all measures; however, both the anodal excitatory ipsilesional group and the cathodal inhibitory contralesional group will show significantly greater improvement compared with the other 2 groups. The investigators will also find evidence clarifying whether the presence or absence of motor-evoked potentials (MEPs) has predictive value regarding which tDCS configuration would be most effective for a particular subject.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Chronic stroke patients
- Single stroke
- Chronic (more than 12 months after from stroke)
- At least 18 years old, but there is no upper age range for this project.
- Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.
Exclusion Criteria:
- History of head injury with loss of consciousness, seizure, severe alcohol or drug abuse, psychiatric illness
- Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
- Cognitive deficit severe enough to preclude informed consent
- Positive pregnancy test or being of childbearing age and not using appropriate contraception
- Participants with history of untreated depression.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Anodal tDCS with motor training
20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training.
Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
|
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
|
|
Comparateur actif: Cathodal tDCS with motor training
20 minutes of cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training.
Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
|
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
|
|
Comparateur actif: Dual tDCS with motor training
20 minutes of anodal transcranial direct current stimulation applied to the ipsilesional hemisphere and cathodal transcranial direct current stimulation applied to the contralesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training.
Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
|
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
|
|
Comparateur factice: Sham tDCS with motor training
20 minutes of sham transcranial direct current stimulation applied to the ipsilesional hemisphere (intervention) paired with 3 hours of intensive, task-oriented upper extremity motor training.
Transcranial direct current stimulation will be delivered using the Neuroconn Eldith stimulator by Magstim.
|
Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change in Fugl Meyer Assessment
Délai: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
|
Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Change in Action Research Arm Test
Délai: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
|
Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
|
|
Change in Stroke Impact Scale
Délai: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
|
Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
|
Collaborateurs et enquêteurs
Parrainer
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
- 11CRP7220009
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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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Essais cliniques sur Neuroconn Eldith stimulator by Magstim
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Institut National de la Santé Et de la Recherche...Assistance Publique - Hôpitaux de ParisComplétéExcitabilité du cortex moteur primaire diaphragmatiqueFrance
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Centre d'Investigation Clinique et Technologique...Adep AssistanceComplété