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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03164213
Enrollment
30
Registered
2017-05-23
Start date
2018-05-01
Completion date
2020-04-30
Last updated
2018-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Stroke

Keywords

tDCS, aphasia

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.

Interventions

DEVICEexperimental: 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.

DEVICEsham 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.

Sponsors

Nachum Soroker, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Change in Western Aphasia Battery Hebrewbaseline (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 Aphasiabaseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.psycholinguistical assessment of aphasia

Contacts

Primary ContactNachum Soroker, M.D
nachums@clalit.org.il052-3625193
Backup ContactCorinne R Zarfati, M.D.
CorinneS@clalit.org.il052-8855626

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026