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).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Sao Paulo, Brazílie, 05652-901
- Danielle Boasquevisque
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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
|
|
Falešný srovnávač: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Safety of the intervention as assessed by frequency of adverse events
Časové okno: 2 weeks
|
frequency of adverse events in the active and sham arms
|
2 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Improvement post treatment as measured by the Modified Rankin Scale
Časové okno: 2 weeks and 14 weeks
|
Improvement post treatment
|
2 weeks and 14 weeks
|
|
Improvement post treatment as measured by the NIH Stroke Scale
Časové okno: 2 weeks and 14 weeks
|
Improvement post treatment
|
2 weeks and 14 weeks
|
|
Improvement post treatment as measured by the Stroke Impact Scale
Časové okno: 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
Časové okno: 2 weeks and 14 weeks
|
Improvement post treatment
|
2 weeks and 14 weeks
|
|
Improvement post treatment as measured by the Modified Ashworth Scale
Časové okno: 2 weeks and 14 weeks
|
Improvement post treatment
|
2 weeks and 14 weeks
|
|
Improvement post treatment as measured by the Motor Activity Log
Časové okno: 2 weeks and 14 weeks
|
Improvement post treatment
|
2 weeks and 14 weeks
|
|
Montreal Cognitive Assessment Test
Časové okno: 2 weeks and 14 weeks
|
No cognitive deterioration post treatment
|
2 weeks and 14 weeks
|
|
Structural Connectivity as measured by diffusion tensor imaging analysis
Časové okno: 2 weeks
|
Improvement post treatment
|
2 weeks
|
|
Functional Connectivity as measured by resting-state functional magnetic imaging analysis
Časové okno: 2 weeks
|
Improvement post treatment
|
2 weeks
|
|
Improvement post treatment as measured by the Barthel index
Časové okno: 2 week and 14 weeks
|
Improvement post treatment
|
2 week and 14 weeks
|
|
Safety of the intervention as assessed by frequency of adverse events
Časové okno: 14 weeks
|
frequency of adverse events in the active and sham arms
|
14 weeks
|
|
Improvement post treatment as measured by Pittsburgh Sleep Quality Index
Časové okno: 2 week and 14 weeks
|
Improvement post treatment
|
2 week and 14 weeks
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Adriana B Conforto, MD Phd, Hospital Israelita Albert Einstein
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 225014
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Sham tDCS
-
Universidad de AlmeriaSecretaría General de Universidades, Investigación y Tecnología, Junta de...Zápis na pozvánkuPoruchy související s látkamiŠpanělsko
-
Mariella EnocNáborMentální anorexie | Poruchy příjmu potravy | Poruchy přejídáníItálie
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)DokončenoVelká depresivní poruchaSpojené státy
-
Charite University, Berlin, GermanyPhysikalisch-Technische Bundesanstalt Institut Berlin (PTB)DokončenoZdravé starší dospěléNěmecko
-
Charite University, Berlin, GermanyPhysikalisch-Technische Bundesanstalt Institut Berlin (PTB)DokončenoZdravé starší dospěléNěmecko
-
University Hospital, Clermont-FerrandZatím nenabírámeMrtvice | Neuropatická bolest | Centrální bolest po mrtviciFrancie
-
The Hong Kong Polytechnic UniversityNáborElektroencefalografie | Transkraniální stimulace stejnosměrným proudem | Porucha autistického spektraHongkong
-
Charite University, Berlin, GermanyDokončeno
-
Wolnei CaumoDokončenoFibromyalgieBrazílie
-
University of HelsinkiNáborPřežil rakovinu prsu | Obezita, nadváhaFinsko