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

NCT03164213 | Unknown

• 1 other identifier: loe170037ctil
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Aphasia

Keywords

tDCS; aphasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

Experimental tDCS

EXPERIMENTAL

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

sham tDCS

SHAM COMPARATOR

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

Interventions

experimental: tDCS DEVICE

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.

Also known as: tDCS

Experimental tDCS

sham tDCS DEVICE

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.

sham tDCS

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unstable clinical state, craniotomy, epilepsy, heart pacer or lack of cooperation

Sponsors & Collaborators

• Nachum Soroker, MD: lead

MeSH Terms

Conditions

Stroke; Aphasia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Nachum Soroker, M.D.

  Loewenstein Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nachum Soroker, M.D

CONTACT

052-3625193; nachums@clalit.org.il

Corinne R Zarfati, M.D.

CONTACT

052-8855626; CorinneS@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Department of neurologic rehabilitation, Loewenstein

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 23, 2017
• Study Start: May 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: April 30, 2020
• Last Updated: March 14, 2018

Record last verified: 2018-03