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