[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05845047":3,"trial-entities:NCT05845047":131,"trial-summary:NCT05845047":134},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":45,"secondary_outcomes":50,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":15,"eligibility_criteria":66,"std_ages":70,"locations":73,"central_contacts":92,"overall_officials":95,"references":98,"see_also_links":130},"NCT05845047","IRB00387816","Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine","PICTURE IT: Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine","RECRUITING","2031-10","2026-09","2026-09-08","2023-05-31","Johns Hopkins University","OTHER",false,"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.","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.",[19,20],"Aphasia","Stroke",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},70,"ESTIMATED",[30,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":37},"BEHAVIORAL","PICTURE-IT","The speech-language pathologist (SLP) will provide one of the following stimuli hierarchically:\n\n1. Single words depicted in the picture, then with written and spoken labels\n2. 2-word phrases depicted in the picture and then with written and spoken word\n3. Subject-Verb-Object sentence depicted in the picture and then with written and spoken sentences\n4. Two-sentence event, depicted with photos and subsequently with two written and spoken sentences\n5. Short story depicted with a video clip and subsequently with printed and spoken narrative.\n\nSessions 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.",[35,36],"CoDeLT Intervention-PICTURE IT Intervention","PICTURE IT Intervention-CoDeLT Intervention",[38],"Producing Increasingly Complex Themes Using Right-hemisphere Engagement Implemented with Telemedicine",{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"CoDeLT","The speech-language pathologist (SLP) will facilitate the computer-delivered naming treatment, consisting of a picture\u002Fseen and heard spoken word verification task.\n\nA 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.\n\nSessions 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.",[35,36],[44],"Computer Delivered Lexical Treatment",[46],{"measure":47,"description":48,"timeFrame":49},"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",[51,54,57,60],{"measure":52,"description":53,"timeFrame":49},"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\u002Fnumber 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.",{"measure":55,"description":56,"timeFrame":49},"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.",{"measure":58,"description":59,"timeFrame":49},"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.",{"measure":61,"description":62,"timeFrame":49},"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.","ALL","18 Years","99 Years",{"inclusion":67,"exclusion":68,"raw_text":69},[],[],"Inclusion Criteria:\n\n1. Age 18 or older\n2. Premorbid proficiency in English\n3. Left hemisphere ischemic or hemorrhagic stroke confirmed by imaging, which occurred either 1-4 months or ≥ 6 months ago\n4. Diagnosis of aphasia secondary to stroke as defined using the Western Aphasia Battery-Revised Aphasia Quotient \\\u003C 93.8.\n5. Capable of giving informed consent or indicating another to provide informed consent\n\nExclusion Criteria:\n\n1. Prior history of neurologic disease affecting the brain (e.g., brain tumor, multiple sclerosis, traumatic brain injury) other than stroke\n2. Prior history of severe psychiatric illness, developmental disorders or intellectual disability (e.g., PTSD, schizophrenia, obsessive-compulsive disorder, autism spectrum disorders)\n3. Inability to follow the treatment procedure as indicated by appropriate (not necessarily accurate) engagement during 5 probes of each.\n4. Uncorrected severe visual loss or hearing loss by self-report and medical records",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":89},"Johns Hopkins School of Medicine","Baltimore","Maryland","21287","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Argye E Hillis, MD","CONTACT","410-614-2381","argye@jhmi.edu",{"name":87,"role":83,"email":88},"Melissa D Stockbridge, PhD","md.stockbridge@jhmi.edu",{"lat":90,"lon":91},39.29038,-76.61219,[93,94],{"name":82,"role":83,"phone":84,"email":85},{"name":87,"role":83,"email":88},[96],{"name":82,"affiliation":13,"role":97},"PRINCIPAL_INVESTIGATOR",[99,103,106,109,112,115,118,121,124,127],{"pmid":100,"type":101,"citation":102},"4717723","BACKGROUND","Albert ML, Sparks RW, Helm NA. Melodic intonation therapy for aphasia. Arch Neurol. 1973 Aug;29(2):130-1. doi: 10.1001\u002Farchneur.1973.00490260074018. No abstract available.",{"pmid":104,"type":101,"citation":105},"20395612","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\u002FSTROKEAHA.109.576785. Epub 2010 Apr 15.",{"pmid":107,"type":101,"citation":108},"30242341","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\u002F2018_AJSLP-17-0131.",{"pmid":110,"type":101,"citation":111},"35832655","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\u002F02687038.2021.1907291. Epub 2021 May 11.",{"pmid":113,"type":101,"citation":114},"15814000","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\u002F0898929053279487.",{"pmid":116,"type":101,"citation":117},"19811814","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\u002Fj.bandl.2009.08.001. Epub 2009 Oct 6.",{"pmid":119,"type":101,"citation":120},"30150003","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\u002Fj.brs.2018.08.009. Epub 2018 Aug 18.",{"pmid":122,"type":101,"citation":123},"1573197","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\u002Fgeronj\u002F47.3.p154.",{"pmid":125,"type":101,"citation":126},"35918503","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\u002Fnyas.14848. Epub 2022 Aug 2.",{"pmid":128,"type":101,"citation":129},"16638796","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\u002Fbrain\u002Fawl090. Epub 2006 Apr 25.",[],{"nct_id":4,"conditions":132,"biomarkers":133},[19,20],[],{"nct_id":4,"found":135,"summary":136,"prompt_version":146},true,{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This is a pilot crossover study with 70 participants. The order of the two treatments (PICTURE-IT and CoDeLT) will be random, and the people assessing your progress will not know which treatment you received.","completed","Investigating PICTURE-IT and CoDeLT for Aphasia After Stroke","This study is looking at two behavioral language treatments for people who have aphasia (difficulty with language) after a stroke. The treatments are called PICTURE-IT and CoDeLT. PICTURE-IT aims to help you produce more complex language by engaging the right side of your brain. CoDeLT is a computer-based treatment that helps with naming objects. Researchers want to see if PICTURE-IT is better at improving how much you can say and how well you can describe things compared to CoDeLT. You may be able to join if you are 18 or older, speak English, and had a stroke that caused aphasia either 1-4 months ago or 6 months or more ago. The main goal is to see how much your ability to describe a picture changes after treatment, measured at baseline and one week later. The current recruitment status is unclear.","Your discourse will be assessed one week after treatment. Your discourse and naming abilities will also be assessed 2 weeks and 2 months after both treatments.",140,"You will receive two different behavioral language treatments. Your language abilities will be assessed before and immediately after each treatment, and again at 2 weeks and 2 months after both treatments. Optional saliva samples may also be collected.","Not stated in the trial record.",[32,40],"v2"]