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

Primary Purpose

Aphasia, Stroke

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anodal transcranial direct current stimulation
Sham transcranial direct current stimulation
Speech-language therapy
Sponsored by
Louisiana State University and A&M College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring aphasia, stroke, tDCS, language, stimulation, brain, speech therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

  • Louisiana State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

A-tDCS & speech-language therapy

Sham-tDCS & speech-language therapy

Arm Description

Anodal transcranial direct current stimulation (2 mA) plus speech-language therapy for 24 sessions (20-minutes per each 60-minute treatment session) over the course of 12 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2mA for a maximum of 20 minutes.

Sham transcranial direct current stimulation (2 mA) plus speech-language therapy for 24 sessions (20-minutes per each 60-minute treatment session) over the course of 12 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 mA.

Outcomes

Primary Outcome Measures

Production of Correct Information Units (CIUs) in Cinderella narrative
Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, and appropriate in context

Secondary Outcome Measures

Western Aphasia Battery-Revised (WAB-R)
Change in performance on Part 1 of WAB-R (Aphasia Quotient)
Communication Activities of Daily Living-2 (CADL-2)
Change in performance on CADL-2
Philadelphia Naming Test - Short Form (PNT)
Change in performance on PNT

Full Information

First Posted
September 2, 2017
Last Updated
October 2, 2023
Sponsor
Louisiana State University and A&M College
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1. Study Identification

Unique Protocol Identification Number
NCT03272906
Brief Title
Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy
Official Title
Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisiana State University and A&M College

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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, and at follow-up.
Detailed Description
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 12 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
aphasia, stroke, tDCS, language, stimulation, brain, speech therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-tDCS & speech-language therapy
Arm Type
Experimental
Arm Description
Anodal transcranial direct current stimulation (2 mA) plus speech-language therapy for 24 sessions (20-minutes per each 60-minute treatment session) over the course of 12 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2mA for a maximum of 20 minutes.
Arm Title
Sham-tDCS & speech-language therapy
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation (2 mA) plus speech-language therapy for 24 sessions (20-minutes per each 60-minute treatment session) over the course of 12 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 mA.
Intervention Type
Device
Intervention Name(s)
Anodal transcranial direct current stimulation
Other Intervention Name(s)
(A-tDCS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham transcranial direct current stimulation
Other Intervention Name(s)
Sham
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Speech-language therapy
Other Intervention Name(s)
SLT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Production of Correct Information Units (CIUs) in Cinderella narrative
Description
Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, and appropriate in context
Time Frame
Following 12 weeks of speech-language therapy and at 6-week follow up
Secondary Outcome Measure Information:
Title
Western Aphasia Battery-Revised (WAB-R)
Description
Change in performance on Part 1 of WAB-R (Aphasia Quotient)
Time Frame
Following 12 weeks of speech-language therapy and at 6-week follow up
Title
Communication Activities of Daily Living-2 (CADL-2)
Description
Change in performance on CADL-2
Time Frame
Following 12 weeks of speech-language therapy and at 6-week follow up
Title
Philadelphia Naming Test - Short Form (PNT)
Description
Change in performance on PNT
Time Frame
Following 12 weeks of speech-language therapy and at 6-week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. Susan Duncan, PhD, CCC-SLP
Organizational Affiliation
Lousiana State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louisiana State University
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70803
Country
United States

12. IPD Sharing Statement

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

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