Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke (NEUROSTIM)
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.
This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.
Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Sao Paulo, Brésil, 05652-901
- Danielle Boasquevisque
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment.
- Unilateral paresis of upper limb
- National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b .
- Ability to provide written informed consent (patient ou legal representative).
Exclusion Criteria:
- Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke.
- Neurologic diseases except migraine.
- Modified Rankin Scale > 2 prior to stroke.
- Advanced systemic disease such as cancer or advanced chronic renal disease.
- Clinical instability such as uncontrolled cardiac arrhythmia or heart failure.
- Contraindication for physical therapy.
- Pregnancy.
- Absolute or relative contraindications to tDCS: metallic prosthesis in the head or neck; lesions on the scalp, history of neurosurgery, pacemaker.
- Comprehension aphasia
- Dementia
- Cerebellar stroke or ataxia caused by involvement of cerebellar pathways in the brainstem
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: Active tDCS+ Physical Therapy
Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes.
After active session of tDCS, the patient will receive physical therapy for 60 minutes.
Number of treatment sessions: 6 (3 times a week, for 2 weeks)
|
Active tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA).
Physical therapy will be administered for 60 minutes
|
|
Comparateur factice: Sham tDCS+Physical Therapy
Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks) |
In sham tDCS, no current will be delivered through the tDCS device.
Physical therapy will be administered for 60 minutes
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Safety of the intervention as assessed by frequency of adverse events
Délai: 2 weeks
|
frequency of adverse events in the active and sham arms
|
2 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Improvement post treatment as measured by the Modified Rankin Scale
Délai: 2 weeks and 14 weeks
|
Improvement post treatment
|
2 weeks and 14 weeks
|
|
Improvement post treatment as measured by the NIH Stroke Scale
Délai: 2 weeks and 14 weeks
|
Improvement post treatment
|
2 weeks and 14 weeks
|
|
Improvement post treatment as measured by the Stroke Impact Scale
Délai: 2 weeks and 14 weeks
|
Improvement post treatment
|
2 weeks and 14 weeks
|
|
Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke
Délai: 2 weeks and 14 weeks
|
Improvement post treatment
|
2 weeks and 14 weeks
|
|
Improvement post treatment as measured by the Modified Ashworth Scale
Délai: 2 weeks and 14 weeks
|
Improvement post treatment
|
2 weeks and 14 weeks
|
|
Improvement post treatment as measured by the Motor Activity Log
Délai: 2 weeks and 14 weeks
|
Improvement post treatment
|
2 weeks and 14 weeks
|
|
Montreal Cognitive Assessment Test
Délai: 2 weeks and 14 weeks
|
No cognitive deterioration post treatment
|
2 weeks and 14 weeks
|
|
Structural Connectivity as measured by diffusion tensor imaging analysis
Délai: 2 weeks
|
Improvement post treatment
|
2 weeks
|
|
Functional Connectivity as measured by resting-state functional magnetic imaging analysis
Délai: 2 weeks
|
Improvement post treatment
|
2 weeks
|
|
Improvement post treatment as measured by the Barthel index
Délai: 2 week and 14 weeks
|
Improvement post treatment
|
2 week and 14 weeks
|
|
Safety of the intervention as assessed by frequency of adverse events
Délai: 14 weeks
|
frequency of adverse events in the active and sham arms
|
14 weeks
|
|
Improvement post treatment as measured by Pittsburgh Sleep Quality Index
Délai: 2 week and 14 weeks
|
Improvement post treatment
|
2 week and 14 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Adriana B Conforto, MD Phd, Hospital Israelita Albert Einstein
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
- 225014
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Sham tDCS
-
Ospedale Policlinico San MartinoItalian Multiple Sclerosis FoundationRecrutementSclérose en plaques | Déficience cognitiveItalie
-
Children's Hospital Medical Center, CincinnatiRésilié
-
Federal University of ParaíbaUniversidade Federal do Rio Grande do NorteInconnueAccident vasculaire cérébral | Déficience cognitive | Infarctus cérébralBrésil
-
Medical University of South CarolinaComplétéAccident vasculaire cérébralÉtats-Unis
-
National Cancer Institute (NCI)RecrutementTumeurs | Tumeurs solidesÉtats-Unis
-
Hôpital le VinatierInconnueTrouble obsessionnel compulsifFrance
-
University of OklahomaVA Office of Research and DevelopmentRésiliéIschémie cérébrale | Infarctus cérébralÉtats-Unis
-
Universidade Federal de PernambucoInconnue
-
University of MinnesotaMinneapolis Veterans Affairs Medical CenterRésiliéLa schizophrénieÉtats-Unis
-
Phramongkutklao College of Medicine and HospitalInconnueLésion de reperfusion ischémiqueThaïlande