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.
Restor Neurol Neurosci
; 37(4): 333-346, 2019.
Article
en En
| MEDLINE
| ID: mdl-31227673
ABSTRACT
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 tDCSâ+âresistance training and 2) sham tDCSâ+âresistance 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 (nâ=â7) or sham-tDCS (nâ=â7) groups. Both groups improved on the clinical outcome measures, but these changes were not significantly different between groups (pâ>â0.17). 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 (pâ>â0.38). 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.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Evaluación de Resultado en la Atención de Salud
/
Accidente Cerebrovascular
/
Extremidad Superior
/
Entrenamiento de Fuerza
/
Estimulación Transcraneal de Corriente Directa
/
Rehabilitación de Accidente Cerebrovascular
Tipo de estudio:
Clinical_trials
Límite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Restor Neurol Neurosci
Asunto de la revista:
NEUROLOGIA
Año:
2019
Tipo del documento:
Article
País de afiliación:
Canadá