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

Study Overview
=================
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

Official Title
-----------------
Targeted Transcranial Direct Current Stimulation to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia

Conditions
-----------------
Stroke, Aphasia

Intervention / Treatment
-----------------
* Device: Active Comparator: Experimental: Active cathodal tDCS + language training
* Behavioral: Sham Comparator: Placebo cathodal tDCS + Speech and language


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental: Active cathodal tDCS + Speech-language training<br>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. | Device: Active Comparator: Experimental: Active cathodal tDCS + language training<br>* 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.<br>* Other names: Behavioral: Speech and Language Training;|
| Sham Comparator: Comparator: Placebo cathodal tDCS + Speech-language training<br>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.. | Behavioral: Sham Comparator: Placebo cathodal tDCS + Speech and language<br>* Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Picture Naming of trained items | Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement | 3 months | 
| 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) | 3 months | 
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discourse informativeness - Main Concept Production | Change in discourse informativeness as measured by main concept scores; increased values indicate improvement | 3 months | 
| 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 | 3 months | 
| Picture Naming of untrained items - Boston Naming Test | Change in naming of pictures of untrained items; 60 pictured items; higher score indicates improvement | 3 months | 
| 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 | 3 months | 
| 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 | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Aphasia, brain stimulation, communication problems, speech and language therapy