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

Primary Purpose

Stroke, Aphasia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
experimental: tDCS
sham tDCS
Sponsored by
Nachum Soroker, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring tDCS, aphasia

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Experimental tDCS

    sham tDCS

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    Change in "Shemesh" 100 nouns test (Biran and Friedmann 2005)
    language test

    Secondary Outcome Measures

    Change in Western Aphasia Battery Hebrew
    aphasia assessment
    Change in Psycholinguistic Assessments of Language Processing in Aphasia
    psycholinguistical assessment of aphasia

    Full Information

    First Posted
    April 24, 2017
    Last Updated
    March 13, 2018
    Sponsor
    Nachum Soroker, MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03164213
    Brief Title
    Facilitation of Brain Plasticity for Language Recovery in Patients With Aphasia Due to Stroke
    Official Title
    Facilitation of Brain Plasticity for Language Recovery in Patients With Aphasia Due to Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2018 (Anticipated)
    Primary Completion Date
    December 30, 2019 (Anticipated)
    Study Completion Date
    April 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Nachum Soroker, MD

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Aphasia
    Keywords
    tDCS, aphasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental tDCS
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    sham tDCS
    Arm Type
    Sham Comparator
    Arm Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    experimental: tDCS
    Other Intervention Name(s)
    tDCS
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    sham tDCS
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in "Shemesh" 100 nouns test (Biran and Friedmann 2005)
    Description
    language test
    Time Frame
    baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
    Secondary Outcome Measure Information:
    Title
    Change in Western Aphasia Battery Hebrew
    Description
    aphasia assessment
    Time Frame
    baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
    Title
    Change in Psycholinguistic Assessments of Language Processing in Aphasia
    Description
    psycholinguistical assessment of aphasia
    Time Frame
    baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nachum Soroker, M.D
    Phone
    052-3625193
    Email
    nachums@clalit.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Corinne R Zarfati, M.D.
    Phone
    052-8855626
    Email
    CorinneS@clalit.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nachum Soroker, M.D.
    Organizational Affiliation
    Loewenstein Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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