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Clinical Trials/NCT03164213
NCT03164213
Unknown
Not Applicable

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

Nachum Soroker, MD0 sites30 target enrollmentMay 1, 2018
ConditionsStrokeAphasia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Nachum Soroker, MD
Enrollment
30
Primary Endpoint
Change in "Shemesh" 100 nouns test (Biran and Friedmann 2005)
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
April 30, 2020
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nachum Soroker, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Nachum Soroker, MD

Head, Department of neurologic rehabilitation, Loewenstein

Loewenstein Hospital

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

Outcomes

Primary Outcomes

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

Time Frame: baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.

language test

Secondary Outcomes

  • Change in Western Aphasia Battery Hebrew(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(baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.)

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