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

25. september 2018 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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)
Enhet: 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).
Annen: 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)
Enhet: Sham tDCS
In sham tDCS, no current will be delivered through the tDCS device.
Annen: Physical Therapy
Physical therapy will be administered for 60 minutes

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospital Israelita Albert Einstein

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2015

Primær fullføring (Faktiske)

31. mars 2018

Studiet fullført (Faktiske)

31. mars 2018

Datoer for studieregistrering

Først innsendt

24. april 2015

Først innsendt som oppfylte QC-kriteriene

22. mai 2015

Først lagt ut (Anslag)

27. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. september 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. september 2018

Sist bekreftet

1. september 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 225014

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

IPD-planbeskrivelse

Deidentified imaging data will be shared with collaborators

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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