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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05845047
Acronym
PICTURE-IT
Enrollment
70
Registered
2023-05-06
Start date
2023-05-31
Completion date
2031-10-01
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Stroke

Brief summary

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

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.

Interventions

BEHAVIORALPICTURE-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.

BEHAVIORALCoDeLT

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.

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The study is to be conducted in a blinded assessor manner. The participants and the clinician performing the behavioral assessments will know the treatment assignment, as there is no way to mask the participants from this information. The PI will have access to the unblinded list of randomization codes and treatment assignments. Technicians who were not involved in any of the treatment sessions will review videos of all of the assessments and will score the participants without knowledge of treatment order assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18 or older 2. Premorbid proficiency in English 3. Left hemisphere ischemic or hemorrhagic stroke confirmed by imaging, which occurred either 1-4 months or ≥ 6 months ago 4. Diagnosis of aphasia secondary to stroke as defined using the Western Aphasia Battery-Revised Aphasia Quotient \< 93.8. 5. Capable of giving informed consent or indicating another to provide informed consent

Exclusion criteria

1. Prior history of neurologic disease affecting the brain (e.g., brain tumor, multiple sclerosis, traumatic brain injury) other than stroke 2. Prior history of severe psychiatric illness, developmental disorders or intellectual disability (e.g., PTSD, schizophrenia, obsessive-compulsive disorder, autism spectrum disorders) 3. Inability to follow the treatment procedure as indicated by appropriate (not necessarily accurate) engagement during 5 probes of each. 4. Uncorrected severe visual loss or hearing loss by self-report and medical records

Design outcomes

Primary

MeasureTime frameDescription
Change in discourse content as assessed by z-score for the number of meaning-carrying units used in describing a pictureBaseline, 1 week after treatmentChange 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

MeasureTime frameDescription
Change in discourse informational efficiency as assessed by z-score for the number of syllables of meaning-carrying units used in describing a pictureBaseline, 1 week after treatmentChange 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.
Change in accuracy of naming objects as assessed by the Boston Naming TestBaseline, 1 week after treatmentChange 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.
Change in accuracy of naming actions as assessed by the Hopkins Action Naming Assessment formBaseline, 1 week after treatmentChange 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.
Change in resting state functional connectivity as assessed by near-infrared spectroscopyBaseline, 1 week after treatmentMeasure 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.

Countries

United States

Contacts

CONTACTArgye E Hillis, MD
argye@jhmi.edu410-614-2381
CONTACTMelissa D Stockbridge, PhD
md.stockbridge@jhmi.edu
PRINCIPAL_INVESTIGATORArgye E Hillis, MD

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026