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Completed

NCT Number: NCT03272906

Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy

Study Design: This is a within-subjects crossover design. Subjects will participate in the procedures twice, once under each condition (active vs. sham stimulation). The order of conditions will be counter-balanced across subjects. Stimulation will target ventral inferior frontal gyrus (IFG) and will be paired with standard speech-language therapy. Outcome measures will be acquired at the beginning and end of a semester of standard speech-language therapy.

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Key information

Conditions

Aphasia Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Communication Disorders Language Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louisiana State University

Baton Rouge, Louisiana, 70803, United States

About this study

Baseline Behavioral Assessment: Medical and neurological history will be taken. Western Aphasia Battery-Revised, Communication Activities of Daily Living-2, and Philadelphia Naming Test (short form) will be administered. Narrative will be elicited (Cinderella story). Some of these procedures will be videorecorded for later transcription. Subjects will also complete a pre-tDCS safety screening questionnaire.

tDCS: Participants will undergo placement of 2 tDCS electrodes. For all subjects, the anodal electrode will be placed at the following locations (EEG 10-20 system):

(i) over the left inferior frontal gyrus (crossing point between T3-Fz and F7-Cz)

The cathodal electrode will be placed at the second site:

(ii) over right frontal pole (Fp2)

Two types of stimulation will be given, an active condition and a sham condition. In the sham condition, stimulation is ramped up over the first 30 seconds (as in the active condition), but then discontinued. This gives the physical perception of stimulation without the modulatory effects.

Stimulation will be delivered by a tDCS device with the following parameters for intensity and duration:

  • Intensity: 2 mA
  • Duration: 20 minutes

tDCS will be provided for the first 20 minutes of each aphasia therapy session provided at the LSU Speech-Language-Hearing Clinic. The therapy sessions last for one hour and are provided twice weekly for 8 weeks over the course of an academic semester (fall and spring).

Post-Therapy/Stimulation Assessment: Western Aphasia Battery-Revised, Communication Activities of Daily Living-2, and Philadelphia Naming Test (short form) will be administered as before therapy. Cinderella narrative will again be elicited. Some of these procedures will again be videorecorded for later transcription. A tDCS sensations survey will also be completed at the final assessment to determine the effectiveness of blinding.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single, unilateral stroke resulting in aphasia
  • Competency to provide written informed consent
  • Ability to participate in standard aphasia therapy

Exclusion criteria

  • Serious psychological condition
  • Serious neurological condition, other than stroke
  • Serious medical condition
  • Pregnancy
  • History of seizures
  • Presence of electronic or metal implants (e.g., pacemaker, vagal nerve stimulator, etc.).

Treatment and study plan

anodal transcranial direct current stimulation

Device

2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 60-minute treatment session.

Other names: (A-tDCS)

Sham Transcranial Direct Current Stimulation

Device

2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition.

Other names: Sham

Speech-language therapy

Behavioral

Therapy tasks will be determined by the clinician on an individualized basis and will not be affected by this research protocol. The only difference between the clinical therapy that is normally provided in the clinic and this research paradigm is the application of tDCS electrodes during therapy. Therapist is blinded to stimulation type.

Other names: SLT

Primary outcomes

  1. Production of Correct Information Units (CIUs) in Cinderella narrative

    Time frame: Following 8 weeks of speech-language therapy

    Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, and appropriate in context

Secondary outcomes

  1. Western Aphasia Battery-Revised (WAB-R)

    Time frame: Following 8 weeks of speech-language therapy

    Change in performance on Part 1 of WAB-R (Aphasia Quotient)

  2. Communication Activities of Daily Living-2 (CADL-2)

    Time frame: Following 8 weeks of speech-language therapy

    Change in performance on CADL-2

  3. Philadelphia Naming Test - Short Form (PNT)

    Time frame: Following 8 weeks of speech-language therapy

    Change in performance on PNT

Sponsors and collaborators

Lead sponsor

Louisiana State University and A&M College

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2023
First posted
Sep 6, 2017
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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