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tDCS as an Adjuvant to Intensive Speech Therapy for Chronic Post Stroke Aphasia

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ClinicalTrials.gov Identifier: NCT02801864
Recruitment Status : Unknown
Verified June 2016 by Austin Speech Labs.
Recruitment status was:  Enrolling by invitation
First Posted : June 16, 2016
Last Update Posted : July 2, 2017
Sponsor:
Collaborators:
Burke Medical Research Institute
University of Texas
Information provided by (Responsible Party):
Austin Speech Labs

Brief Summary:
The purpose of this study is to determine if transcranial direct current stimulation (tDCS) in conjunction with intensive speech therapy will improve sentence production and word retrieval in individuals with chronic post stroke aphasia.

Condition or disease Intervention/treatment Phase
Aphasia Language Device: Real tDCS Device: Sham tDCS Other: Intensive Speech Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) an Adjuvant to Intensive Speech Therapy in Chronic Post Stroke Aphasia
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined real tDCS + IST
Participants will receive tDCS via a Starstim device at 1mA for 20min of the total three hours of intensive speech therapy time at the beginning of each session. The stimulation will be ramped up for 45 seconds and ramped down for 15 seconds. For the experimental group, the stimulation will be ramped up for 45 seconds and stay there for 20 min. The participants will receive three weeks of tDCS and continue receiving only intensive speech therapy for five weeks for three hours a day.
Device: Real tDCS
Participants will receive tDCS at 1mA for 20min of the total three hours of intensive speech therapy time at the beginning of each session. Stimulation will be provided via an electrode using a Starstim device.

Other: Intensive Speech Therapy
Participants will receive one hour of group therapy and two hours of individual therapy that will follow VNeST format. The purpose of therapy will be to have the client generate verbs and nouns in written and verbal form.

Sham Comparator: Combined sham tDCS + IST
Participants will receive tDCS via a Starstim device at 1mA for 20min of the total three hours of intensive speech therapy time at the beginning of each session. For the sham group, the stimulation will be ramped up for 45 seconds and ramped down for 15 seconds. The stimulation will be ramped up for 45 seconds and then ramp down after the initial 45 seconds. The participants will receive three weeks of tDCS and continue receiving only intensive speech therapy for five weeks for three hours a day.
Device: Sham tDCS
Participants will receive tDCS at 1mA for 20min of the total three hours of intensive speech therapy time at the beginning of each session. Stimulation will be provided via an electrode using a Starstim device.

Other: Intensive Speech Therapy
Participants will receive one hour of group therapy and two hours of individual therapy that will follow VNeST format. The purpose of therapy will be to have the client generate verbs and nouns in written and verbal form.




Primary Outcome Measures :
  1. Improvement in naming nouns as measured by Object Naming Test [ Time Frame: After eight weeks of treatment ]
    Nouns will be tested using An Object Naming Test by Dr.Judith Druks and Dr.Jackie Masterson

  2. Improvement in naming Action verbs as measured by Northwestern Assessment Verbs Sentences [ Time Frame: After eight weeks of treatment ]
    naming Action Verbs will be measured using Northwestern Assessment of Verbs(NAVS)

  3. Improvement in sentence production as measured by NAVS [ Time Frame: After eight weeks of treatment ]
    Sentence production will be measured using Northwestern Assessment of Verbs and Sentences(NAVS)


Secondary Outcome Measures :
  1. Improvement in picture description as measured by Western Aphasia Battery [ Time Frame: After eight weeks of treatment ]
    Western Aphasia Battery(WAB) standardized measurement will be used pre and post treatment to analyze changes in sentence structures.



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have suffered a left CVA
  • Demonstrate 50% or greater on the Auditory Verbal Comprehension section of the WAB

Exclusion Criteria:

  • Have any other type of neurological condition
  • Have any other medical conditions, such as seizures or implants
  • Have suffered a right CVA
  • Are receiving teletherapy

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): NCT02801864


Locations
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United States, Texas
Austin Speech Labs
Austin, Texas, United States, 78757
Sponsors and Collaborators
Austin Speech Labs
Burke Medical Research Institute
University of Texas
Investigators
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Principal Investigator: Thomas Marquardt, Ph.D. University of Texas at Austin
Principal Investigator: Shilpa Shamapant, M.S.,M.A. Austin Speech Labs
Principal Investigator: Dylan Edwards, Ph.D. Burke Medical Rehabilitation and Research Institute

Publications:
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Responsible Party: Austin Speech Labs
ClinicalTrials.gov Identifier: NCT02801864     History of Changes
Other Study ID Numbers: 2015-05-0071
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared between Austin Speech Labs, University of Texas, Austin and Burke Medical Research Institute

Keywords provided by Austin Speech Labs:
tDCS
transcranial direct current stimulation
intensive speech therapy
chronic
post stroke
aphasia
production
language

Additional relevant MeSH terms:
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Aphasia
Communication Disorders
Speech Disorders
Language Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders