AphasiaPICTURE-ITNCT05845047
Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine
A study testing PICTURE-IT and CoDeLT in people with Aphasia and Stroke, run by Johns Hopkins University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- PICTURE-IT and CoDeLT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melissa D Stockbridge, PhD contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Argye E Hillis, MD, 410-614-2381, argye@jhmi.edu
Melissa D Stockbridge, PhD, md.stockbridge@jhmi.edu
About this study
Official title: PICTURE IT: Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine
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.
Read the 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.
- Being tested
- PICTURE-IT, CoDeLT
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICTURE-ITBehavioural
Also called Producing Increasingly Complex Themes Using Right-hemisphere Engagement Implemented with Telemedicine
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.
CoDeLTBehavioural
Also called Computer Delivered Lexical Treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| PICTURE IT Intervention-CoDeLT Intervention | Experimental | Participants will receive PICTURE IT Intervention for 15 sessions followed by Computer Delivered Lexical Treatment (CoDeLT)Intervention for 15 sessions Receives: Behavioral: PICTURE-IT; Behavioral: CoDeLT |
| CoDeLT Intervention-PICTURE IT Intervention | Active comparator | Participants will receive Computer Delivered Lexical Treatment (CoDeLT) Intervention for 15 sessions followed by PICTURE IT Intervention for 15 sessions Receives: Behavioral: PICTURE-IT; Behavioral: CoDeLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 week after treatment
Secondary outcomes (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
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.
Measured: Baseline, 1 week after treatment
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.
Measured: Baseline, 1 week after treatment
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.
Measured: Baseline, 1 week after treatment
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.
Measured: Baseline, 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start31 May 2023
- Primary completionAug 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Argye E Hillis, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845047
- Sponsor's protocol ID
- IRB00387816
- Acronym
- PICTURE-IT
- Status last verified
- Sep 2026
- First submitted
- 25 Apr 2023
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 4717723Baker 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.
PubMed 20395612Berube 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.
PubMed 30242341Breining 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.
PubMed 35832655Crosson 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.
PubMed 15814000Crosson 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.
PubMed 19811814Fridriksson 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.
PubMed 30150003Mack 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.
PubMed 1573197Popescu 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.
PubMed 35918503Saur 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.
PubMed 16638796
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PICTURE IT: Producing Increasingly Complex Themes Using Right-hemisphere Engagement (PICTURE) Implemented With Telemedicine
- ClinicalTrials.gov ID
- NCT05845047
- Acronym / sponsor ID
- PICTURE-IT / IRB00387816
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICTURE IT Intervention-CoDeLT Intervention | Experimental | Behavioral: PICTURE-IT, Behavioral: CoDeLTParticipants will receive PICTURE IT Intervention for 15 sessions followed by Computer Delivered Lexical Treatment (CoDeLT)Intervention for 15 sessions |
| CoDeLT Intervention-PICTURE IT Intervention | Active comparator | Behavioral: PICTURE-IT, Behavioral: CoDeLTParticipants will receive Computer Delivered Lexical Treatment (CoDeLT) Intervention for 15 sessions followed by PICTURE IT Intervention for 15 sessions |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICTURE-ITAlso: Producing Increasingly Complex Themes Using Right-hemisphere Engagement Implemented with TelemedicineThe 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. | Behavioural | CoDeLT Intervention-PICTURE IT Intervention, PICTURE IT Intervention-CoDeLT Intervention |
| CoDeLTAlso: Computer Delivered Lexical TreatmentThe 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. | Behavioural | CoDeLT Intervention-PICTURE IT Intervention, PICTURE IT Intervention-CoDeLT Intervention |
Primary outcome
Change in discourse content as assessed by z-score for the number of meaning-carrying units used in describing a picture
Time frame: Baseline, 1 week after treatment
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.
4 secondary outcomes
Change in discourse informational efficiency as assessed by z-score for the number of syllables of meaning-carrying units used in describing a picture
Time frame: Baseline, 1 week after treatment
Change in accuracy of naming objects as assessed by the Boston Naming Test
Time frame: Baseline, 1 week after treatment
Change in accuracy of naming actions as assessed by the Hopkins Action Naming Assessment form
Time frame: Baseline, 1 week after treatment
Change in resting state functional connectivity as assessed by near-infrared spectroscopy
Time frame: Baseline, 1 week after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 4717723Albert 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.
- Background: PubMed 20395612Baker 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.
- Background: PubMed 30242341Berube 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.
- Background: PubMed 35832655Breining 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.
- Background: PubMed 15814000Crosson 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.
- Background: PubMed 19811814Crosson 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.
- Background: PubMed 30150003Fridriksson 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.
- Background: PubMed 1573197Mack 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.
- Background: PubMed 35918503Popescu 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.
- Background: PubMed 16638796Saur 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa D Stockbridge, PhD contact
Argye E Hillis, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICTURE-IT and CoDeLT in people with Aphasia and Stroke, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Argye E Hillis, MD (410-614-2381, argye@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in discourse content as assessed by z-score for the number of meaning-carrying units used in describing a picture (time frame: Baseline, 1 week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05845047, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.