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

NCT ID: NCT05845047

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2031-10-31

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.

Conditions

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Aphasia Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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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

Group Type EXPERIMENTAL

PICTURE-IT

Intervention Type BEHAVIORAL

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.

CoDeLT

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

PICTURE-IT

Intervention Type BEHAVIORAL

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.

CoDeLT

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Producing Increasingly Complex Themes Using Right-hemisphere Engagement Implemented with Telemedicine Computer Delivered Lexical Treatment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Argye E Hillis, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Argye E Hillis, MD

Role: CONTACT

410-614-2381

Melissa D Stockbridge, PhD

Role: CONTACT

Facility Contacts

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Argye E Hillis, MD

Role: primary

410-614-2381

Melissa D Stockbridge, PhD

Role: backup

References

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Albert ML, Sparks RW, Helm NA. Melodic intonation therapy for aphasia. Arch Neurol. 1973 Aug;29(2):130-1. doi: 10.1001/archneur.1973.00490260074018. No abstract available.

Reference Type BACKGROUND
PMID: 4717723 (View on PubMed)

Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.

Reference Type BACKGROUND
PMID: 20395612 (View on PubMed)

Berube S, Nonnemacher J, Demsky C, Glenn S, Saxena S, Wright A, Tippett DC, Hillis AE. Stealing Cookies in the Twenty-First Century: Measures of Spoken Narrative in Healthy Versus Speakers With Aphasia. Am J Speech Lang Pathol. 2019 Mar 11;28(1S):321-329. doi: 10.1044/2018_AJSLP-17-0131.

Reference Type BACKGROUND
PMID: 30242341 (View on PubMed)

Breining BL, Faria AV, Caffo B, Meier EL, Sheppard SM, Sebastian R, Tippett DC, Hillis AE. Neural regions underlying object and action naming: Complementary evidence from acute stroke and primary progressive aphasia. Aphasiology. 2022;36(6):732-760. doi: 10.1080/02687038.2021.1907291. Epub 2021 May 11.

Reference Type BACKGROUND
PMID: 35832655 (View on PubMed)

Crosson B, Moore AB, Gopinath K, White KD, Wierenga CE, Gaiefsky ME, Fabrizio KS, Peck KK, Soltysik D, Milsted C, Briggs RW, Conway TW, Gonzalez Rothi LJ. Role of the right and left hemispheres in recovery of function during treatment of intention in aphasia. J Cogn Neurosci. 2005 Mar;17(3):392-406. doi: 10.1162/0898929053279487.

Reference Type BACKGROUND
PMID: 15814000 (View on PubMed)

Crosson B, Moore AB, McGregor KM, Chang YL, Benjamin M, Gopinath K, Sherod ME, Wierenga CE, Peck KK, Briggs RW, Rothi LJ, White KD. Regional changes in word-production laterality after a naming treatment designed to produce a rightward shift in frontal activity. Brain Lang. 2009 Nov;111(2):73-85. doi: 10.1016/j.bandl.2009.08.001. Epub 2009 Oct 6.

Reference Type BACKGROUND
PMID: 19811814 (View on PubMed)

Fridriksson J, Elm J, Stark BC, Basilakos A, Rorden C, Sen S, George MS, Gottfried M, Bonilha L. BDNF genotype and tDCS interaction in aphasia treatment. Brain Stimul. 2018 Nov-Dec;11(6):1276-1281. doi: 10.1016/j.brs.2018.08.009. Epub 2018 Aug 18.

Reference Type BACKGROUND
PMID: 30150003 (View on PubMed)

Mack WJ, Freed DM, Williams BW, Henderson VW. Boston Naming Test: shortened versions for use in Alzheimer's disease. J Gerontol. 1992 May;47(3):P154-8. doi: 10.1093/geronj/47.3.p154.

Reference Type BACKGROUND
PMID: 1573197 (View on PubMed)

Popescu T, Stahl B, Wiernik BM, Haiduk F, Zemanek M, Helm H, Matzinger T, Beisteiner R, Fitch WT. Melodic Intonation Therapy for aphasia: A multi-level meta-analysis of randomized controlled trials and individual participant data. Ann N Y Acad Sci. 2022 Oct;1516(1):76-84. doi: 10.1111/nyas.14848. Epub 2022 Aug 2.

Reference Type BACKGROUND
PMID: 35918503 (View on PubMed)

Saur D, Lange R, Baumgaertner A, Schraknepper V, Willmes K, Rijntjes M, Weiller C. Dynamics of language reorganization after stroke. Brain. 2006 Jun;129(Pt 6):1371-84. doi: 10.1093/brain/awl090. Epub 2006 Apr 25.

Reference Type BACKGROUND
PMID: 16638796 (View on PubMed)

Other Identifiers

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IRB00387816

Identifier Type: -

Identifier Source: org_study_id

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