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Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke (NEUROSTIM)

25. september 2018 opdateret af: Hospital Israelita Albert Einstein

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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
      • Sao Paulo, Brasilien, 05652-901
        • Danielle Boasquevisque

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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)
Enhed: Active tDCS
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).
Andet: Physical Therapy
Physical therapy will be administered for 60 minutes
Sham-komparator: 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)
Enhed: Sham tDCS
In sham tDCS, no current will be delivered through the tDCS device.
Andet: Physical Therapy
Physical therapy will be administered for 60 minutes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety of the intervention as assessed by frequency of adverse events
Tidsramme: 2 weeks
frequency of adverse events in the active and sham arms
2 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement post treatment as measured by the Modified Rankin Scale
Tidsramme: 2 weeks and 14 weeks
Improvement post treatment
2 weeks and 14 weeks
Improvement post treatment as measured by the NIH Stroke Scale
Tidsramme: 2 weeks and 14 weeks
Improvement post treatment
2 weeks and 14 weeks
Improvement post treatment as measured by the Stroke Impact Scale
Tidsramme: 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
Tidsramme: 2 weeks and 14 weeks
Improvement post treatment
2 weeks and 14 weeks
Improvement post treatment as measured by the Modified Ashworth Scale
Tidsramme: 2 weeks and 14 weeks
Improvement post treatment
2 weeks and 14 weeks
Improvement post treatment as measured by the Motor Activity Log
Tidsramme: 2 weeks and 14 weeks
Improvement post treatment
2 weeks and 14 weeks
Montreal Cognitive Assessment Test
Tidsramme: 2 weeks and 14 weeks
No cognitive deterioration post treatment
2 weeks and 14 weeks
Structural Connectivity as measured by diffusion tensor imaging analysis
Tidsramme: 2 weeks
Improvement post treatment
2 weeks
Functional Connectivity as measured by resting-state functional magnetic imaging analysis
Tidsramme: 2 weeks
Improvement post treatment
2 weeks
Improvement post treatment as measured by the Barthel index
Tidsramme: 2 week and 14 weeks
Improvement post treatment
2 week and 14 weeks
Safety of the intervention as assessed by frequency of adverse events
Tidsramme: 14 weeks
frequency of adverse events in the active and sham arms
14 weeks
Improvement post treatment as measured by Pittsburgh Sleep Quality Index
Tidsramme: 2 week and 14 weeks
Improvement post treatment
2 week and 14 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital Israelita Albert Einstein

Efterforskere

  • Ledende efterforsker: Adriana B Conforto, MD Phd, Hospital Israelita Albert Einstein

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2015

Primær færdiggørelse (Faktiske)

31. marts 2018

Studieafslutning (Faktiske)

31. marts 2018

Datoer for studieregistrering

Først indsendt

24. april 2015

Først indsendt, der opfyldte QC-kriterier

22. maj 2015

Først opslået (Skøn)

27. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 225014

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

IPD-planbeskrivelse

Deidentified imaging data will be shared with collaborators

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sham tDCS

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