Clinical trial NCT05845047: Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine
Official title: PICTURE IT: Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aphasia
Stroke
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in discourse content as assessed by z-score for the number of meaning-carrying units used in describing a picture
timeFrame: Baseline, 1 week after treatment
Secondary outcomes:
measure: Change in discourse informational efficiency as assessed by z-score for the number of syllables of meaning-carrying units used in describing a picture
timeFrame: Baseline, 1 week after treatment
measure: Change in accuracy of naming objects as assessed by the Boston Naming Test
timeFrame: Baseline, 1 week after treatment
measure: Change in accuracy of naming actions as assessed by the Hopkins Action Naming Assessment form
timeFrame: Baseline, 1 week after treatment
measure: Change in resting state functional connectivity as assessed by near-infrared spectroscopy
timeFrame: Baseline, 1 week after treatment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Argye E Hillis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.