Efficacy, safety, and tolerability of bilateral transcranial direct current stimulation combined to a resistance training program in chronic stroke survivors: A double-blind, randomized, placebo-controlled pilot study
Notice bibliographique
Résumé
BACKGROUND: Transcranial direct current stimulation (tDCS) is a promising tool for stroke rehabilitation. Yet, so far, results from the available clinical trials are inconclusive. OBJECTIVES: The primary objective of the present work was to test the efficacy of multiple sessions of tDCS combined with a highly standardized and progressive resistance training program of the affected upper limb in individuals in the chronic phase of recovery after a stroke. Secondary objectives were to test the safety and tolerability of these combined interventions. METHODS: This two-arm parallel pilot trial recruited participants that were ≥18 years old, community-dwelling, and had sustained a supratentorial stroke ≥6 months prior to the study. They were allocated using a stratified randomization into two groups: 1) real tDCS + resistance training and 2) sham tDCS + resistance training. The resistance training program targeted the affected upper limb and consisted in 60 minutes of exercises, 3 times/week over 4 weeks. During each session, participants received either real- or sham-tDCS, using a bi-hemispheric montage for the first 20 minutes, and were blinded to the tDCS intervention. Outcome measures of clinical efficacy (Fugl-Meyer Assessment, Box and Block Test, Wolf Motor Function Test, grip strength, modified Ashworth scale and Motor Activity Log) were assessed by a blinded evaluator before and after the 4-week training program. Safety and tolerability were evaluated, respectively, by the number and characteristics of tDCS adverse events and dropout rates with their reasons. RESULTS: From the 147 individuals screened for eligibility, 14 participants (68.9±10.0 years old; 70.9±57.6 months post-stroke) met the selection criteria and were allocated to real-tDCS (n = 7) or sham-tDCS (n = 7) groups. Both groups improved on the clinical outcome measures, but these changes were not significantly different between groups (p > 0.17). No dropout occurred throughout the study. Participants frequently reported mild skin tingling during the administration of both real- and sham-tDCS, and no group difference was noted for its frequency and intensity (p > 0.38). One participant having received real-tDCS complained about a mild skin burning sensation after two sessions. The a priori sample size analysis performed on the Fugl-Meyer Assessment scores revealed that 56 participants would be required in a future clinical trial to reach 80% power at a significance level of 0.05. CONCLUSIONS: In this pilot study, repeated sessions of bi-hemispheric tDCS coupled with resistance training were found safe and tolerable for individuals at the chronic phase post-stroke. However, the use of tDCS did not result in additional sensorimotor improvements when compared to sham-tDCS. Further research is needed to better assess the clinical benefits of combining non-invasive transcranial stimulation with rehabilitation after a stroke.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».