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

March 13, 2018 updated by: 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Device: 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.
Other Names:
  • tDCS
Sham Comparator: 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).
Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Western Aphasia Battery Hebrew
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nachum Soroker, MD

Investigators

  • Principal Investigator: Nachum Soroker, M.D., Loewenstein Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

April 30, 2020

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

May 21, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • loe170037ctil

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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