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Transcranial Direct Current Stimulation (tDCS) With Verb Network Strengthening Treatment (VNeST) in Chronic Aphasia

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ClinicalTrials.gov Identifier: NCT04142866
Recruitment Status : Not yet recruiting
First Posted : October 29, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
E. Susan Duncan, Louisiana State University and A&M College

Brief Summary:
The purpose of this study is to assess changes in language abilities of participants with chronic, post-stroke aphasia following an 8-week therapy period combined with brain stimulation. The investigators use a stimulation method called transcranial direct current stimulation (tDCS). The investigators cover two electrodes in damp sponges, place them on the scalp, and pass a weak electrical current between them. Some of this current passes through the brain and can change brain activity. One electrode is placed over language areas a bit above and in front of the left ear. The other is placed on the forehead above the right eye. Stimulation is provided twice a week for 8 weeks during aphasia therapy. The investigators believe that this stimulation may increase the effectiveness of therapy.

Condition or disease Intervention/treatment Phase
Aphasia Stroke Device: Anodal transcranial direct current stimulation Device: Sham transcranial direct current stimulation Behavioral: Speech-Language Therapy (SLT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) With Verb Network Strengthening Treatment (VNeST) in Chronic Aphasia
Estimated Study Start Date : January 6, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: A-tDCS & speech-language therapy
Anodal transcranial direct current stimulation (2 milliamps [mA]) plus aphasia therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2 milliamps (mA) for a maximum of 20 minutes.
Device: Anodal transcranial direct current stimulation
2 milliamps (mA) of stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode) is placed on the scalp over the targeted cortical region and the other (cathode) is placed on the right side of the forehead. Ramping up of the current to 2 milliamps (mA) occurs over 30 seconds to allow participants to habituate to the tingling sensation. In the active tDCS condition, stimulation continues for the first 20 minutes of the 60-minute treatment session, and then ramps back down to 0 milliamps (mA).
Other Name: A-tDCS

Behavioral: Speech-Language Therapy (SLT)
Therapy provided is Verb Network Strengthening Treatment (VNeST). Therapy sessions last for 60 minutes and are provided twice weekly for 8 weeks. Active or sham tDCS is delivered during the first 20 minutes of therapy. The therapist is blinded to stimulation condition (active or sham).
Other Name: SLT

Sham Comparator: Sham-tDCS & speech-language therapy
Sham transcranial direct current stimulation (2 milliamps [mA]) plus aphasia therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. Electrodes will be placed as in A-tDCS. Current will be ramped up for the first 30 seconds following which the intensity will drop to 0 milliamps (mA).
Device: Sham transcranial direct current stimulation
2 milliamps (mA) of stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode) is placed on the scalp over the targeted cortical region and the other (cathode) is placed on the right side of the forehead. Ramping up of the current to 2 milliamps (mA) occurs over 30 seconds to allow participants to habituate to the tingling sensation. In the sham tDCS condition, the current is only on for 30 seconds before it is ramped back down to 0 milliamps (mA), although the electrodes are still worn for 20 minutes.
Other Name: Sham

Behavioral: Speech-Language Therapy (SLT)
Therapy provided is Verb Network Strengthening Treatment (VNeST). Therapy sessions last for 60 minutes and are provided twice weekly for 8 weeks. Active or sham tDCS is delivered during the first 20 minutes of therapy. The therapist is blinded to stimulation condition (active or sham).
Other Name: SLT




Primary Outcome Measures :
  1. Production of Correct Information Units (CIUs) on Discourse Tasks [ Time Frame: Collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up ]
    Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, informative, and appropriate in context (Nicholas & Brookshire, 1993).


Secondary Outcome Measures :
  1. Western Aphasia Battery-Revised [ Time Frame: Collected once at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up ]
    Aphasia quotient calculated from this comprehensive aphasia battery. Range is 0 to 100, where 100 represents a perfect score and scores above 93.8 indicate that aphasia is not present.

  2. Boston Naming Test [ Time Frame: Collected twice at baseline, immediately (<1 week) post-treatment, and at 8 week follow-up ]
    Number correct of the 60 items on this naming test



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

This study recruits individuals with post-stroke aphasia as well as a group of healthy volunteers matched for age, sex, and education.

INCLUSION Criteria:

  • Right handed (pre-stroke for participants with aphasia)
  • High school education or equivalent
  • Native English fluency without early 2nd language exposure (before age 10)
  • Ability to perform the required discourse and MRI tasks (determined via in-person screening)

Additional INCLUSION Criteria for participants with APHASIA:

  • Single-event left hemisphere stroke > 6 months prior to enrollment
  • Aphasia diagnosis per Western Aphasia Battery-Revised
  • Not receiving any other speech therapy for the entire study period (20 weeks)
  • Ability to perform the required therapy tasks (determined via in-person screening)

EXCLUSION Criteria:

  • Failed vision or hearing screening
  • MRI contraindications (including pacemaker)
  • Pregnancy
  • History of seizure or change in seizure medication in past 12 months
  • History of speech/language, psychiatric, or neurological disorder, or current serious medical condition (except chronic stroke comorbidities for participants with aphasia)

Additional EXCLUSION criteria for participants with APHASIA are:

  • Unmodifiable hair style precluding scalp contact by electrodes
  • Sensitive scalp by self-report

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): NCT04142866


Contacts
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Contact: E. Susan Duncan, PhD, CCC-SLP 225 578 8838 duncan1@lsu.edu

Sponsors and Collaborators
Louisiana State University and A&M College
Investigators
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Principal Investigator: E. Susan Duncan, PhD, CCC-SLP Louisiana State University Health Sciences Center in New Orleans

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Responsible Party: E. Susan Duncan, Assistant Professor, Louisiana State University and A&M College
ClinicalTrials.gov Identifier: NCT04142866    
Other Study ID Numbers: LouisianaSUAMC
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The investigators are committed to open, reproducible science to ensure rigor and complete transparency of our methods and data quality. Therefore, after the publication of findings, the investigators will share data with the scientific research community.

Anonymized functional magnetic resonance imaging data and associated behavioral data will be uploaded to the OpenNeuro database: https://openneuro.org/

Time Frame: The investigators plan to post data following conclusion of this study (anticipated 5/31/2023). The shared data will be available in perpetuity.
Access Criteria: Data will be available on OpenNeuro database: https://openneuro.org/ Accessing data on OpenNeuro requires sign in with Google or ORCID (Open Researcher and Contributor ID; https://orcid.org/).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by E. Susan Duncan, Louisiana State University and A&M College:
aphasia
stroke
tDCS
language
stimulation
brain
speech therapy
Additional relevant MeSH terms:
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Aphasia
Nervous System Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms