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

Stroke Clinical Trial

— PICTURE IT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05845047
• Other study ID #: IRB00387816
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: October 2031

Study information

• Verified date: November 2023
• Source: Johns Hopkins University
• Contact: Argye E Hillis, MD
• Phone: 410-614-2381
• Email: argye[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2031
• Est. primary completion date: August 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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 or more than 6 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

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in discourse content as assessed by z-score for the number of meaning-carrying units used in describing a picture	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.	Baseline, 1 week after treatment
Secondary	Change in discourse informational efficiency as assessed by z-score for the number of syllables of meaning-carrying units used in describing a picture	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.	Baseline, 1 week after treatment
Secondary	Change in accuracy of naming objects as assessed by the Boston Naming Test	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.	Baseline, 1 week after treatment
Secondary	Change in accuracy of naming actions as assessed by the Hopkins Action Naming Assessment form	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.	Baseline, 1 week after treatment
Secondary	Change in resting state functional connectivity as assessed by near-infrared spectroscopy	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.	Baseline, 1 week after treatment