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

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ClinicalTrials.gov Identifier: NCT03164213
Recruitment Status : Not yet recruiting
First Posted : May 23, 2017
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Nachum Soroker, MD, Loewenstein Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Aphasia Device: experimental: tDCS Device: sham tDCS Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Facilitation of Brain Plasticity for Language Recovery in Patients With Aphasia Due to Stroke
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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 Name: 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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164213


Contacts
Contact: Nachum Soroker, M.D 052-3625193 nachums@clalit.org.il
Contact: Corinne R Zarfati, M.D. 052-8855626 CorinneS@clalit.org.il

Sponsors and Collaborators
Nachum Soroker, MD
Investigators
Principal Investigator: Nachum Soroker, M.D. Loewenstein Hospital

Responsible Party: Nachum Soroker, MD, Head, Department of neurologic rehabilitation, Loewenstein, Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT03164213     History of Changes
Other Study ID Numbers: loe170037ctil
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

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

Keywords provided by Nachum Soroker, MD, Loewenstein Hospital:
tDCS
aphasia

Additional relevant MeSH terms:
Aphasia
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms