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

Not Applicable

• Conditions: Stroke; Aphasia
• Interventions: Device: sham tDCS

• Registration Number: NCT03164213
• Lead Sponsor: Nachum Soroker, MD

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.

Study Timeline

• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-05-21
• Study First Posted: 2017-05-23
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-14
• Study Start: 2018-05-01
• Primary Completion: 2019-12-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham tDCS	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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