Cathodal Transcranial Direct Current Stimulation in Acute Ischemic Stroke: Pilot Randomized Controlled Trial.

Acute Disease Aged Aged, 80 and over Double-Blind Method Female Humans Ischemic Stroke / diagnostic imaging Magnetic Resonance Imaging Male Middle Aged Transcranial Direct Current Stimulation
magnetic resonance imaging middle cerebral artery neuroprotection reperfusion thrombectomy

Journal

Stroke
ISSN: 1524-4628
Titre abrégé: Stroke
Pays: United States
ID NLM: 0235266

Informations de publication

Date de publication:
06 2021
Historique:
pubmed: 20 4 2021
medline: 6 1 2022
entrez: 19 4 2021
Statut: ppublish

Résumé

In acute stroke, preventing infarct growth until complete recanalization occurs is a promising approach as an adjunct to reperfusion therapies to reduce infarct size and improve outcome. In rodent models, cathodal transcranial direct current stimulation (C-tDCS) decreases peri-infarct depolarizations and reduces infarct volume. We hypothesized that C-tDCS would nonpharmacologically reduce infarct growth in hyperacute middle cerebral artery territory stroke patients receiving reperfusion therapy. STICA (Cathodal Transcranial Direct Stimulation in Acute Middle Cerebral Artery Stroke) was a pilot single-center, double-blind, 2-arms 1:1 randomized trial evaluating the safety, feasibility, and efficacy of C-tDCS versus sham stimulation in patients eligible for recanalization therapies. Magnetic resonance imaging was obtained both on admission and 24 hours later. The primary end point was 24-hour infarct growth. Secondary outcomes were (1) National Institutes of Health Stroke Scale score difference between day 7 and admission and (2) 3-month modified Rankin Scale score. Forty-five patients were randomized. Median magnetic resonance imaging-to-C-tDCS start time was 45 minutes; C-tDCS was started before completion of recanalization procedure in all patients. The intervention proved feasible in all patients. No major adverse effects occurred in either group. There was no significant difference between active and sham groups for any end point. However, an apparent trend towards smaller infarct growth in the C-tDCS arm was observed in the whole group (unadjusted median difference [IC95%]: −2.2 mL [−12.2 to 1.5]) and in the prespecified subsamples with moderate-to-severe stroke and large vessel occlusion (−5.7 mL [−21.6 to 2.6] and −7.7 mL [−24.2 to 2.6], respectively). C-tDCS was feasible and well tolerated. No significant difference was found between the active and sham groups. However, the data suggest potential benefits of C-tDCS in patients with National Institutes of Health Stroke Scale score of >10 or large vessel occlusion. Using the observed effect size and standard α=5% and β=20%, samples of 102 and 86, respectively, can be estimated for future trials in patients with these characteristics. Randomized trials particularly targeting these populations may be warranted.

Sections du résumé

Background and Purpose
In acute stroke, preventing infarct growth until complete recanalization occurs is a promising approach as an adjunct to reperfusion therapies to reduce infarct size and improve outcome. In rodent models, cathodal transcranial direct current stimulation (C-tDCS) decreases peri-infarct depolarizations and reduces infarct volume. We hypothesized that C-tDCS would nonpharmacologically reduce infarct growth in hyperacute middle cerebral artery territory stroke patients receiving reperfusion therapy.
Methods
STICA (Cathodal Transcranial Direct Stimulation in Acute Middle Cerebral Artery Stroke) was a pilot single-center, double-blind, 2-arms 1:1 randomized trial evaluating the safety, feasibility, and efficacy of C-tDCS versus sham stimulation in patients eligible for recanalization therapies. Magnetic resonance imaging was obtained both on admission and 24 hours later. The primary end point was 24-hour infarct growth. Secondary outcomes were (1) National Institutes of Health Stroke Scale score difference between day 7 and admission and (2) 3-month modified Rankin Scale score.
Results
Forty-five patients were randomized. Median magnetic resonance imaging-to-C-tDCS start time was 45 minutes; C-tDCS was started before completion of recanalization procedure in all patients. The intervention proved feasible in all patients. No major adverse effects occurred in either group. There was no significant difference between active and sham groups for any end point. However, an apparent trend towards smaller infarct growth in the C-tDCS arm was observed in the whole group (unadjusted median difference [IC95%]: −2.2 mL [−12.2 to 1.5]) and in the prespecified subsamples with moderate-to-severe stroke and large vessel occlusion (−5.7 mL [−21.6 to 2.6] and −7.7 mL [−24.2 to 2.6], respectively).
Conclusions
C-tDCS was feasible and well tolerated. No significant difference was found between the active and sham groups. However, the data suggest potential benefits of C-tDCS in patients with National Institutes of Health Stroke Scale score of >10 or large vessel occlusion. Using the observed effect size and standard α=5% and β=20%, samples of 102 and 86, respectively, can be estimated for future trials in patients with these characteristics. Randomized trials particularly targeting these populations may be warranted.

Identifiants

DOI: 10.1161/STROKEAHA.120.032056 PMID: 33866820
pubmed: 33866820
doi: 10.1161/STROKEAHA.120.032056
doi:

Types de publication

Clinical Trial, Phase II Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1951-1960

Auteurs

Estelle Pruvost-Robieux (E)

Neurophysiology Department (E.P.-R., A.M., M.G.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.
Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, Inserm U1266, France (E.P.-R., J.B., G.T., C.O., D.C., J.-C.B., J.-L.M., M.G.).
FHU Neurovasc, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM UMR 1266 (E.P.-R., J.B., G.T., A.M., C.O., D.C., J.-C.B., J.-L.M., M.G.).

Joseph Benzakoun (J)

Neuroradiology Department (J.B., C.O.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.
Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, Inserm U1266, France (E.P.-R., J.B., G.T., C.O., D.C., J.-C.B., J.-L.M., M.G.).
FHU Neurovasc, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM UMR 1266 (E.P.-R., J.B., G.T., A.M., C.O., D.C., J.-C.B., J.-L.M., M.G.).

Guillaume Turc (G)

Neurology Department (G.T., C.L., V.D., D.C., J.-C.B., J.-L.M.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.
Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, Inserm U1266, France (E.P.-R., J.B., G.T., C.O., D.C., J.-C.B., J.-L.M., M.G.).
FHU Neurovasc, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM UMR 1266 (E.P.-R., J.B., G.T., A.M., C.O., D.C., J.-C.B., J.-L.M., M.G.).

Angela Marchi (A)

Neurophysiology Department (E.P.-R., A.M., M.G.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.
FHU Neurovasc, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM UMR 1266 (E.P.-R., J.B., G.T., A.M., C.O., D.C., J.-C.B., J.-L.M., M.G.).

Rossella Letizia Mancusi (RL)

Délégation à la Recherche Clinique et à l'Innovation (R.L.M.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.

Catherine Lamy (C)

Neurology Department (G.T., C.L., V.D., D.C., J.-C.B., J.-L.M.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.

Valérie Domigo (V)

Neurology Department (G.T., C.L., V.D., D.C., J.-C.B., J.-L.M.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.

Catherine Oppenheim (C)

Neuroradiology Department (J.B., C.O.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.
Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, Inserm U1266, France (E.P.-R., J.B., G.T., C.O., D.C., J.-C.B., J.-L.M., M.G.).
FHU Neurovasc, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM UMR 1266 (E.P.-R., J.B., G.T., A.M., C.O., D.C., J.-C.B., J.-L.M., M.G.).

David Calvet (D)

Neurology Department (G.T., C.L., V.D., D.C., J.-C.B., J.-L.M.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.
FHU Neurovasc, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM UMR 1266 (E.P.-R., J.B., G.T., A.M., C.O., D.C., J.-C.B., J.-L.M., M.G.).

Jean-Claude Baron (JC)

Neurology Department (G.T., C.L., V.D., D.C., J.-C.B., J.-L.M.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.
Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, Inserm U1266, France (E.P.-R., J.B., G.T., C.O., D.C., J.-C.B., J.-L.M., M.G.).
FHU Neurovasc, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM UMR 1266 (E.P.-R., J.B., G.T., A.M., C.O., D.C., J.-C.B., J.-L.M., M.G.).

Jean-Louis Mas (JL)

Neurology Department (G.T., C.L., V.D., D.C., J.-C.B., J.-L.M.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.
Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, Inserm U1266, France (E.P.-R., J.B., G.T., C.O., D.C., J.-C.B., J.-L.M., M.G.).
FHU Neurovasc, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM UMR 1266 (E.P.-R., J.B., G.T., A.M., C.O., D.C., J.-C.B., J.-L.M., M.G.).

Martine Gavaret (M)

Neurophysiology Department (E.P.-R., A.M., M.G.), GHU Paris Psychiatrie et Neurosciences, Sainte Anne Hospital, Paris.
Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, Inserm U1266, France (E.P.-R., J.B., G.T., C.O., D.C., J.-C.B., J.-L.M., M.G.).
FHU Neurovasc, Institute of Psychiatry and Neuroscience of Paris (IPNP), INSERM UMR 1266 (E.P.-R., J.B., G.T., A.M., C.O., D.C., J.-C.B., J.-L.M., M.G.).

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Classifications MeSH

questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Caractéristiques de la maladie › Maladie aigüe › Cathodal Transcranial Direct Current...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Sujet âgé › Cathodal Transcranial Direct Current...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Sujet âgé › Sujet âgé de 80 ans ou plus › Cathodal Transcranial Direct Current...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en double aveugle › Cathodal Transcranial Direct Current...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Cathodal Transcranial Direct Current...
questionsmedicales.fr › Maladies cardiovasculaires › Maladies vasculaires › Angiopathies intracrâniennes › Accident vasculaire cérébral › Accident vasculaire cérébral ischémique › Cathodal Transcranial Direct Current...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Imagerie diagnostique › Tomographie › Imagerie par résonance magnétique › Cathodal Transcranial Direct Current...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Cathodal Transcranial Direct Current...
questionsmedicales.fr › Disciplines et activités comportementales › Techniques psychologiques › Électrochoc › Stimulation transcrânienne par courant continu › Cathodal Transcranial Direct Current...