Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine

Study Overview
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Brief Summary
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The investigators propose a pilot crossover trial of 2 behavioral language treatments, with randomized order of treatments and blinded assessors, to determine if a therapy designed to stimulate right hemisphere functions (Producing Increasingly Complex Themes Using Right-hemisphere Engagement Implemented with Telemedicine - PICTURE IT; described below) is more effective in improving discourse than a published computer delivered lexical treatment (shown previously to improve naming) in subacute post-stroke aphasia.

Detailed Description
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The investigators will carry out a crossover study with randomized order of treatment conditions and blinded assessors, to compare changes in content and efficiency of discourse (primary outcome measures) from before treatment to immediately after treatment, to compare intervention focused on engaging the right hemisphere (PICTURE IT; see below) to a purely lexical treatment (see details below). Secondary outcome measures will be: (1) changes in discourse from pre-treatment to 2 weeks post-treatment, and (2) changes in naming of objects and actions from immediately before treatment to immediately after treatment, and (3) changes in naming of objects and actions from pre-treatment to 2 months after both treatments. The investigators will also carry out resting state functional near infrared spectroscopy (fNIRS) before and after each treatment to evaluate degree and location (e.g. intrahemispheric right versus left) of changes in connectivity associated with each treatment and with changes in each outcome measure. The investigators will also take saliva samples from participants who agree to this optional part of the study to determine the participants brain-derived neurotrophic factor status.

Official Title
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PICTURE IT: Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine

Conditions
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Aphasia, Stroke

Intervention / Treatment
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* Behavioral: PICTURE-IT
* Behavioral: CoDeLT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of aphasia secondary to stroke and presence of naming deficits (at least 20% errors on the Boston Naming Test or Hopkins Action Naming Assessment) Capable of giving informed consent or indicating another to provide informed consent Age 18 or older The stroke must have occurred between 1 month and 4 months prior to enrollment in the study or more than 6 months prior to enrollment in the study Able to understand therapy tasks (as indicated by 5 probes of each) Exclusion Criteria: Lack of English proficiency (by self/legally authorized representative report) Prior history of neurologic disease affecting the brain (e.g., brain tumor, multiple sclerosis, traumatic brain injury) other than stroke Prior history of severe psychiatric illness, developmental disorders or intellectual disability (e.g., PTSD, schizophrenia, obsessive-compulsive disorder, autism spectrum disorders) Uncorrected severe visual loss or hearing loss by self-report and medical records

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PICTURE IT Intervention-CoDeLT Intervention<br>Participants will receive PICTURE IT Intervention for 15 sessions followed by Computer Delivered Lexical Treatment (CoDeLT)Intervention for 15 sessions | Behavioral: PICTURE-IT<br>* The speech-language pathologist (SLP) will provide one of the following stimuli hierarchically: Single words depicted in the picture, then with written and spoken labels 2-word phrases depicted in the picture and then with written and spoken word Subject-Verb-Object sentence depicted in the picture and then with written and spoken sentences Two-sentence event, depicted with photos and subsequently with two written and spoken sentences Short story depicted with a video clip and subsequently with printed and spoken narrative. Sessions will be completed online with a speech-language pathologist using video conferencing software, using a laptop and a hot spot the investigators will provide if needed. Participants in both groups will receive the same 15 45-minute sessions of a PICTURE-IT.<br>* Other names: Producing Increasingly Complex Themes Using Right-hemisphere Engagement Implemented with Telemedicine;Behavioral: CoDeLT<br>* The speech-language pathologist (SLP) will facilitate the computer-delivered naming treatment, consisting of a picture/seen and heard spoken word verification task. A picture will be presented for two seconds on a laptop computer screen and will be immediately followed by an audio-visual display of a speaker's mouth saying a noun. The spoken word either will or will not match the preceding picture, and the participant must indicate whether the picture and video match or do not match. The computer will provide immediate visual feedback following a response. Sessions will be completed online with a speech-language pathologist using video conferencing software, using a laptop and a hot spot the investigators will provide if needed. Participants in both groups will receive the same 15 45-minute sessions of a PICTURE-IT.<br>* Other names: Computer Delivered Lexical Treatment;|
| Active Comparator: CoDeLT Intervention-PICTURE IT Intervention<br>Participants will receive Computer Delivered Lexical Treatment (CoDeLT) Intervention for 15 sessions followed by PICTURE IT Intervention for 15 sessions | Behavioral: PICTURE-IT<br>* The speech-language pathologist (SLP) will provide one of the following stimuli hierarchically: Single words depicted in the picture, then with written and spoken labels 2-word phrases depicted in the picture and then with written and spoken word Subject-Verb-Object sentence depicted in the picture and then with written and spoken sentences Two-sentence event, depicted with photos and subsequently with two written and spoken sentences Short story depicted with a video clip and subsequently with printed and spoken narrative. Sessions will be completed online with a speech-language pathologist using video conferencing software, using a laptop and a hot spot the investigators will provide if needed. Participants in both groups will receive the same 15 45-minute sessions of a PICTURE-IT.<br>* Other names: Producing Increasingly Complex Themes Using Right-hemisphere Engagement Implemented with Telemedicine;Behavioral: CoDeLT<br>* The speech-language pathologist (SLP) will facilitate the computer-delivered naming treatment, consisting of a picture/seen and heard spoken word verification task. A picture will be presented for two seconds on a laptop computer screen and will be immediately followed by an audio-visual display of a speaker's mouth saying a noun. The spoken word either will or will not match the preceding picture, and the participant must indicate whether the picture and video match or do not match. The computer will provide immediate visual feedback following a response. Sessions will be completed online with a speech-language pathologist using video conferencing software, using a laptop and a hot spot the investigators will provide if needed. Participants in both groups will receive the same 15 45-minute sessions of a PICTURE-IT.<br>* Other names: Computer Delivered Lexical Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in discourse content as assessed by z-score for the number of meaning-carrying units used in describing a picture | Change in z-score for the number of meaning-carrying units used in describing a picture. There is no maximum number of meaning-carrying units, but norms are available to assist in the interpretation of this performance. | Baseline, 1 week after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in discourse informational efficiency as assessed by z-score for the number of syllables of meaning-carrying units used in describing a picture | Change in z-score for the number of syllables/number of meaning-carrying units used in describing a picture. There is no maximum number of meaning-carrying units, but norms are available to assist in the interpretation of this performance. | Baseline, 1 week after treatment | 
| Change in accuracy of naming objects as assessed by the Boston Naming Test | Change in accuracy of naming objects on the 30-item Boston Naming Test. Scores range from 0 to 30 with higher scores meaning better naming ability. | Baseline, 1 week after treatment | 
| Change in accuracy of naming actions as assessed by the Hopkins Action Naming Assessment form | Change in accuracy of naming actions on the 30-item Hopkins Action Naming Assessment. Scores range from 0 to 30 with higher scores meaning better naming ability. | Baseline, 1 week after treatment | 
| Change in resting state functional connectivity as assessed by near-infrared spectroscopy | Measure of correlation between activation of brain regions at rest using functional near-infrared spectroscopy. Right hemisphere intrahemispheric, left hemisphere intrahemispheric, and interhemispheric measures will be examined. | Baseline, 1 week after treatment |