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Facilitation of Brain Plasticity for Language Recovery in Patients With Aphasia Due to Stroke

13. marts 2018 opdateret af: Nachum Soroker, MD
The purpose of this study is to investigate effects of tDCS stimulation in the left primary motor area followed by naming therapy to improve language functions in patients with aphasia in the sub-acute stage.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Transcranial Direct Current Stimulation (tDCS) is a simple and non-intrusive method that has demonstrated promising results in language rehabilitation of patients with aphasia. Various studies have used different stimulation set-ups, some based on prior structural and functional brain mapping in order to choose the optimal stimulation region. An additional approach that was found beneficial is stimulation of the left primary motor area (M1). A major advantage of this approach is its relative simplicity that may increase the application of this intervention in clinical settings. This intervention approach has been studied in patients with chronic aphasia and targeted on naming ability. In the current study the investigators aim to study the influence of a stimulation set-up at M1 in stroke patients suffering from aphasia that are in the sub-acute stage. In addition the investigators aim to study additional language functions including pragmatics and grammar. The study will include 30 patients suffering from aphasia which are in the sub-acute stage. The patients will undergo complete language assessments at 3 time points: baseline, post intervention (third week from recruitment) and one month follow-up. The study group will include 15 patients that will undergo TDCS at the left M1 region followed by naming therapy. The intervention will be given daily for duration of two weeks (5 days/week). The control group will include 15 patients that will undergo the same protocol apart from sham TDCS. The effect of the intervention will be examined taking into account the extent and location of the brain damage on language functions.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

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

25 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • patients post stroke with right hemiplegia and aphasia with cognitive capacity to understand instructions and at the aphasia cut-of level defined by "SHEMESH" assessment

Exclusion Criteria:

  • unstable clinical state, craniotomy, epilepsy, heart pacer or lack of cooperation

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental tDCS
TDCS stimulation at the left M1 region followed by naming therapy. The intervention will be given daily for duration of two weeks (5 days/week).
Enhed: experimental: tDCS
The anode will be placed over the left M1 representation of the hand (C3 of the 10-20 EEG system). Twenty minutes of anodal-tDCS (1mA) will be administered at the beginning of the daily treatment session. Following the stimulation will be 45 minutes of naming therapy.
Andre navne:
  • tDCS
Sham-komparator: sham tDCS
Sham tDCS at the left M1 region followed by naming therapy. The intervention will be given daily for duration of two weeks (5 days/week).
Enhed: sham tDCS

The anode will be placed over the left M1 representation of the hand (C3 of the 10-20 EEG system). Twenty minutes of sham-tDCS will be administered at the beginning of the daily treatment session.

During sham-tDCS, the current will be ramped up and remained at 1mA only for 30 s before ramping down, which does not affect neural functions, but assures effective blinding of participants due to the initial tingling sensation on the scalp. Following the sham stimulation will be 45 minutes of naming therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in "Shemesh" 100 nouns test (Biran and Friedmann 2005)
Tidsramme: baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
language test
baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Western Aphasia Battery Hebrew
Tidsramme: baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
aphasia assessment
baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
Change in Psycholinguistic Assessments of Language Processing in Aphasia
Tidsramme: baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
psycholinguistical assessment of aphasia
baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.

Samarbejdspartnere og efterforskere

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

Sponsor

Nachum Soroker, MD

Efterforskere

  • Ledende efterforsker: Nachum Soroker, M.D., Loewenstein Hospital

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 (Forventet)

1. maj 2018

Primær færdiggørelse (Forventet)

30. december 2019

Studieafslutning (Forventet)

30. april 2020

Datoer for studieregistrering

Først indsendt

24. april 2017

Først indsendt, der opfyldte QC-kriterier

21. maj 2017

Først opslået (Faktiske)

23. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. marts 2018

Sidst verificeret

1. marts 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • loe170037ctil

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Kliniske forsøg med experimental: tDCS

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