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Targeted TDCS to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia. (AphasiatDCS)

Primary Purpose

Stroke, Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Comparator: Experimental: Active cathodal tDCS + language training
Sham Comparator: Placebo cathodal tDCS + Speech and language
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Aphasia, brain stimulation, communication problems, speech and language therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. aged 25-85
  2. must be greater than 1 year post-stroke
  3. must have a diagnosis of aphasia based on impaired performance on the Western Aphasia Battery-Revised, Boston Naming Test, or during discourse production
  4. must be left-hemisphere dominant as demonstrated by aphasia onset subsequent to left hemisphere damage
  5. must be stimulable for naming

Exclusion Criteria:

  1. comorbid neurological disease.
  2. damage to the anterior right hemisphere.
  3. significant mood disorder.
  4. substance/alcohol dependence or abuse within the past year
  5. presence of any implanted electrical device or contraindications to tDCS or MRI
  6. recent medical instability (within 4 weeks)
  7. pregnancy

Sites / Locations

  • University of New Mexico Center for Brain Recovery and RepairRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Experimental: Active cathodal tDCS + Speech-language training

Comparator: Placebo cathodal tDCS + Speech-language training

Arm Description

In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays.

In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays..

Outcomes

Primary Outcome Measures

Picture Naming of trained items
Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement
Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)
Change in response time of naming of pictures of trained items; 0-20 seconds, decreased response time indicates improvement Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)
Naming Efficiency of trained items
Change in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency

Secondary Outcome Measures

Discourse informativeness - Main Concept Production
Change in discourse informativeness as measured by main concept scores; increased values indicate improvement
Efficiency of discourse informativeness - Main Concept Production
Change in efficiency of discourse informativeness; accurate and complete main concepts produced over the time of discourse elicitation (ACs/min); larger numbers indicate greater efficiency
Picture Naming of untrained items - Boston Naming Test
Change in naming of pictures of untrained items; 60 pictured items; higher score indicates improvement
Naming Response Time of untrained items - Boston Naming Test
Change in response time of naming of pictures of untrained items; 0-20 seconds, decreased response time indicates improvement
Naming Efficiency of untrained items - Boston Naming Test
Change in efficiency of naming of pictures of untrained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency

Full Information

First Posted
December 3, 2019
Last Updated
May 1, 2023
Sponsor
University of New Mexico
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT04432883
Brief Title
Targeted TDCS to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia.
Acronym
AphasiatDCS
Official Title
Targeted Transcranial Direct Current Stimulation to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
December 8, 2025 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS), National Institute on Deafness and Other Communication Disorders (NIDCD)

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
62 patients who are one year post stroke and have Aphasia as a result of that stroke will be recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. A combined semantic feature analysis/phonological components analysis treatment will be paired with the stimulation. Two assessment sessions will be pretreatment, 1 session immediately post-treatment, and 1 session at 3 months follow-up.
Detailed Description
Our long-term goal is to develop safe and effective treatments for the communication problems of Aphasia due to stroke that restore patients to higher levels of functioning, decrease disability, and promote higher quality of life. While language therapy for aphasia is effective, improvements are typically slow, and gains may be small. Noninvasive brain stimulation has been suggested as a method to enhance outcomes from language therapy. This study will examine whether outcomes for language therapy with brain stimulation are different from outcomes for language therapy without brain stimulation in people with aphasia. Our central hypotheses are (1) targeted right hemisphere HDtDCS (RH-HD-tDCS) administered in combination with language treatment will result in greater changes in naming accuracy than language treatment with the sham RH-HD-tDCS (2) RH-HD-tDCS plus language treatment will result in greater increases in communication within the affected hemisphere compared to language treatment plus sham RH-HD-tDCS (3) RH-HD-tDCS plus language treatment will result in greater increases in perilesional areas working together immediately post-treatment compared to language treatment plus sham RH-HD-tDCS

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
Keywords
Stroke, Aphasia, brain stimulation, communication problems, speech and language therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Active cathodal tDCS + Speech-language training
Arm Type
Active Comparator
Arm Description
In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays.
Arm Title
Comparator: Placebo cathodal tDCS + Speech-language training
Arm Type
Sham Comparator
Arm Description
In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays..
Intervention Type
Device
Intervention Name(s)
Active Comparator: Experimental: Active cathodal tDCS + language training
Other Intervention Name(s)
Behavioral: Speech and Language Training
Intervention Description
Cathodal tDCS raises neuronal membrane potentials, leading to decreased probability of depolarization from incoming stimuli. Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment.
Intervention Type
Behavioral
Intervention Name(s)
Sham Comparator: Placebo cathodal tDCS + Speech and language
Intervention Description
Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .
Primary Outcome Measure Information:
Title
Picture Naming of trained items
Description
Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement
Time Frame
3 months
Title
Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)
Description
Change in response time of naming of pictures of trained items; 0-20 seconds, decreased response time indicates improvement Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)
Time Frame
3 months
Title
Naming Efficiency of trained items
Description
Change in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Discourse informativeness - Main Concept Production
Description
Change in discourse informativeness as measured by main concept scores; increased values indicate improvement
Time Frame
3 months
Title
Efficiency of discourse informativeness - Main Concept Production
Description
Change in efficiency of discourse informativeness; accurate and complete main concepts produced over the time of discourse elicitation (ACs/min); larger numbers indicate greater efficiency
Time Frame
3 months
Title
Picture Naming of untrained items - Boston Naming Test
Description
Change in naming of pictures of untrained items; 60 pictured items; higher score indicates improvement
Time Frame
3 months
Title
Naming Response Time of untrained items - Boston Naming Test
Description
Change in response time of naming of pictures of untrained items; 0-20 seconds, decreased response time indicates improvement
Time Frame
3 months
Title
Naming Efficiency of untrained items - Boston Naming Test
Description
Change in efficiency of naming of pictures of untrained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 25-85 must be greater than 1 year post-stroke must have a diagnosis of aphasia based on impaired performance on the Western Aphasia Battery-Revised, Boston Naming Test, or during discourse production must be left-hemisphere dominant as demonstrated by aphasia onset subsequent to left hemisphere damage must be stimulable for naming Exclusion Criteria: comorbid neurological disease. damage to the anterior right hemisphere. significant mood disorder. substance/alcohol dependence or abuse within the past year presence of any implanted electrical device or contraindications to tDCS or MRI recent medical instability (within 4 weeks) pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Richardson, Ph.D.
Phone
505 277-1765
Email
jdrichardson@unm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Honey Hubbard
Phone
505-433-7766
Email
hhubbard@unm.edu
Facility Information:
Facility Name
University of New Mexico Center for Brain Recovery and Repair
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darbi Gill
Phone
505-925-4043
Email
DMGill@salud.unm.edu

12. IPD Sharing Statement

Learn more about this trial

Targeted TDCS to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia.

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