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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 su
• Поведенческое 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

Первичные конечные точки

• Change in discourse content as assessed by z-score for the number of meaning-carrying units used in describing a picture [Срок оценки: Baseline, 1 week after treatment]

Вторичные конечные точки (4)

• Change in discourse informational efficiency as assessed by z-score for the number of syllables of meaning-carrying units used in describing a picture [Срок оценки: Baseline, 1 week after treatment]
• Change in accuracy of naming objects as assessed by the Boston Naming Test [Срок оценки: Baseline, 1 week after treatment]
• Change in accuracy of naming actions as assessed by the Hopkins Action Naming Assessment form [Срок оценки: Baseline, 1 week after treatment]
• Change in resting state functional connectivity as assessed by near-infrared spectroscopy [Срок оценки: Baseline, 1 week after treatment]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Johns Hopkins School of Medicine — Baltimore

Публикации

• 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. PMID 4717723
• 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. PMID 20395612
• 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. PMID 30242341
• 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. PMID 35832655
• 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. PMID 15814000
• 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. PMID 19811814
• 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. PMID 30150003
• 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. PMID 1573197

Идентификаторы

NCT: NCT05845047 · IRB00387816

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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