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NCT Number: NCT05845047

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

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.

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Key information

Conditions

Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Premorbid proficiency in English
  • Left hemisphere ischemic or hemorrhagic stroke confirmed by imaging, which occurred either 1-4 months or ≥ 6 months ago
  • Diagnosis of aphasia secondary to stroke as defined using the Western Aphasia Battery-Revised Aphasia Quotient < 93.8.
  • Capable of giving informed consent or indicating another to provide informed consent

Exclusion criteria

  • 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)
  • Inability to follow the treatment procedure as indicated by appropriate (not necessarily accurate) engagement during 5 probes of each.
  • Uncorrected severe visual loss or hearing loss by self-report and medical records

Treatment and study plan

PICTURE-IT

Behavioral

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.

Other names: Producing Increasingly Complex Themes Using Right-hemisphere Engagement Implemented with Telemedicine

CoDeLT

Behavioral

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, phrase, or sentence. The spoken word, phrase, or sentence either will or will not fit 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.

Other names: Computer Delivered Lexical Treatment

Primary outcomes

  1. Change in discourse content as assessed by z-score for the number of meaning-carrying units used in describing a picture

    Time frame: Baseline, 1 week after treatment

    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.

Secondary outcomes

  1. Change in discourse informational efficiency as assessed by z-score for the number of syllables of meaning-carrying units used in describing a picture

    Time frame: Baseline, 1 week after treatment

    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.

  2. Change in accuracy of naming objects as assessed by the Boston Naming Test

    Time frame: Baseline, 1 week after treatment

    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.

  3. Change in accuracy of naming actions as assessed by the Hopkins Action Naming Assessment form

    Time frame: Baseline, 1 week after treatment

    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.

  4. Change in resting state functional connectivity as assessed by near-infrared spectroscopy

    Time frame: Baseline, 1 week after treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Argye E Hillis, MD

CONTACT

[email protected]

410-614-2381

Melissa D Stockbridge, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Acronym: PICTURE IT

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
May 6, 2023
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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