NCT05845047 · Johns Hopkins University
Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine
(PICTURE IT)
What this study is about
The investigators propose a pilot crossover trial of 2 behavioral language treatments, with randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
PICTURE-IT
The speech-language pathologist (SLP) will provide one of the following stimuli hierarchically: 1. Single words depicted in the picture, then with written and spoken labels 2. 2-word phrases depicted in the picture and then with written and spoken word 3. Subject-Verb-Object sentence depicted in the picture and then with written and spoken sentences 4. Two-sentence event, depicted with photos and subsequently with two written and spoken sentences 5. 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.
BEHAVIORAL
CoDeLT
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2025 · Source of record for eligibility and locations