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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03164213
• Other study ID #: loe170037ctil
• Status: Not yet recruiting
• Phase: N/A
• First received: April 24, 2017
• Last updated: March 13, 2018
• Start date: May 1, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2018
• Source: Loewenstein Hospital
• Contact: Nachum Soroker, M.D
• Phone: 052-3625193
• Email: nachums[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nachum Soroker, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in "Shemesh" 100 nouns test (Biran and Friedmann 2005)	language test	baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
Secondary	Change in Western Aphasia Battery Hebrew	aphasia assessment	baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.
Secondary	Change in Psycholinguistic Assessments of Language Processing in Aphasia	psycholinguistical assessment of aphasia	baseline (before intervention), post intervention (on the third week from recruitment) and one month follow-up.