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

Sponsor
Johns Hopkins University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05845047
Collaborator
(none)
70
Enrollment
2
Arms
100
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PICTURE-IT
  • Behavioral: CoDeLT
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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
Primary Purpose:
Treatment
Official Title:
PICTURE IT: Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2031
Anticipated Study Completion Date :
Oct 1, 2031

Arms and Interventions

Arm Intervention/Treatment
Experimental: PICTURE IT Intervention-CoDeLT Intervention

Participants will receive PICTURE IT Intervention for 15 sessions followed by Computer Delivered Lexical Treatment (CoDeLT)Intervention for 15 sessions

Behavioral: PICTURE-IT
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

    • 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. 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.
    Other Names:
  • Computer Delivered Lexical Treatment

    		•
    Active Comparator: CoDeLT Intervention-PICTURE IT Intervention

    Participants will receive Computer Delivered Lexical Treatment (CoDeLT) Intervention for 15 sessions followed by PICTURE IT Intervention for 15 sessions

    Behavioral: PICTURE-IT
    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

    • 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. 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.
    Other Names:
  • Computer Delivered Lexical Treatment

    		•

    Outcome Measures

    Primary Outcome Measures

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

    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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 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)

    2. Capable of giving informed consent or indicating another to provide informed consent

    3. Age 18 or older

    4. The stroke must have occurred between 1 month and 4 months prior to enrollment in the study

    5. Able to understand therapy tasks (as indicated by 5 probes of each)

    Exclusion Criteria:

    1. Lack of English proficiency (by self/legally authorized representative report)

    2. Prior history of neurologic disease affecting the brain (e.g., brain tumor, multiple sclerosis, traumatic brain injury) other than stroke

    3. Prior history of severe psychiatric illness, developmental disorders or intellectual disability (e.g., PTSD, schizophrenia, obsessive-compulsive disorder, autism spectrum disorders)

    4. Uncorrected severe visual loss or hearing loss by self-report and medical records

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    • Principal Investigator: Argye E Hillis, MD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT05845047
    Other Study ID Numbers:
    • IRB00387816
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Aphasia

    Study Results

    No Results Posted as of May 6, 2023