AphasiaPROCoMNCT02916524
Predicting Rehabilitation Outcomes in Bilingual Aphasia Using Computational Modeling
A study testing Semantic Feature Analysis (SFA) in people with Aphasia, run by Boston University Charles River Campus at 3 sites in United States.
Trial summary
The purpose of this investigation is to implement a computational model that can predict and optimize training and cross-language generalization patterns for bilingual persons with aphasia (BPA). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aphasia
- What is being tested?
- Semantic Feature Analysis (SFA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Apr 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any number of years of education
- Bilingual: speaking both Spanish and English (or Chinese and English) with any degree of language proficiency prior to stroke
- Aphasia secondary to a left-hemisphere stroke (diagnosed by a neurologist on the basis of clinical CT/MRI imaging or medical reports)
- Aphasia resulting from stroke or dementia
- Naming deficits must be present with concurrent lexical/semantic impairment
- Visual and auditory acuity sufficient for all assessment and treatment procedures
- Ability to understand study and follow study procedures for the entire length of the study
Who cannot join
- Premorbid history of speech/language disorder
- Proficient in more than just Spanish and English (or Chinese and English)
- Overt, behaviorally noticeable, attentional limitations that interfere with completing the experimental tasks
- Active medical disease that may compromise participation (e.g., cancer undergoing acute treatment, unstable diabetes, renal or hepatic insufficiency, fluctuating systemic immunological disease such as systemic lupus erythematosis, etc.)
- Currently taking medications that are known to exert significant effects on cognitive processes, such as neuroleptics, steroids, anticholinesterase inhibitors, etc.
- Current drug or alcohol use or dependence that would interfere with adherence to study requirements, in the opinion of the principal investigator
Show all 9Show fewer
- Inability or unwillingness of individual to give written informed consent
- Diagnosed with mental illness other than active depression
- Neurological condition other than that which resulted in aphasia
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Austin Speech Labs
Austin, Texas, 78757
Boston University Sargent College
Boston, Massachusetts, 02215
San Francisco State University
San Francisco, California, 94132
About this study
Official title: Double-blind Randomized Trial Investigating the Use of Computational Modeling to Predict Rehabilitation Outcomes in Bilingual Aphasia
The purpose of this investigation is to implement a computational model that can predict and optimize training and cross-language generalization patterns for bilingual persons with aphasia (BPA). The proposed work will determine the best possible treatment program for each individual patient even before they are rehabilitated. In addition, the computational model allows specification of variables such as age of acquisition, language exposure/proficiency, impairment and their systematic influence on a range of language rehabilitation outcomes.
- Conditions
- Aphasia
- Being tested
- Semantic Feature Analysis (SFA)
- Keywords
- Aphasia, Bilingualism, Language therapy, Rehabilitation of speech and language disorders, Speech-language pathology
- Medical subject headings
- Aphasia, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semantic Feature Analysis (SFA)Behavioural
SFA training entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, action associated with item). Treatment is applied to a set of items in the context of single-subject, multiple baseline designs so that replication of treatment effects could be evaluated within and across participants. Treatment will be administered two times per week until prescribed accuracy levels were met during treatment probes or a maximum number of treatment sessions was completed.
| Study group | Role | What they receive |
|---|---|---|
| Model-based | Experimental | Semantic Feature Analysis training will be provided in the language that was selected by the computational model. Receives: Behavioral: Semantic Feature Analysis (SFA) |
| Model-opposite | Active comparator | Semantic Feature Analysis training will be provided in the language opposite to that which was selected by the computational model. Receives: Behavioral: Semantic Feature Analysis (SFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Word Retrieval Accuracy in English and Spanish
Accuracy of naming black and white pictures that are both trained and untrained in English and Spanish will be assessed in naming tests. These tests were conducted repeatedly throughout the study, from baseline (prior to treatment) to the end of treatment. All naming responses were scored using as correct or incorrect. Proportion accuracy was calculated for each set of items for every testing session. Baseline scores were compared to end of treatment scores to obtain individual effect sizes for each sets of items for each participant.
Measured: Through study completion, an average of 10 weeks
Secondary outcomes (4)
Psycholinguistic Assessments of Language Processing in Aphasia (PALPA) in Both Languages
The PALPA/Evaluación del Procesamiento Lingüístico en la Afasia (EPLA) is a standardized assessment for reading simple words and spoken words in both English and Spanish out of 30 words.
Measured: Baseline, post-treatment (on average 10 weeks)
Boston Naming Test (BNT) in Both Languages
The BNT is a standardized naming assessment that includes 60 pictures that can be named in either English or Spanish.
Measured: Baseline, post-treatment (on average 10 weeks)
Western Aphasia Battery (WAB-R) in Both Languages
Western Aphasia Battery:The WAB-R is a standardized, gold-standard assessment for determining the presence, type, and severity of post-stroke aphasia, with excellent reliability and validity. The WAB-R measures performance across a variety of expressive and receptive language domains and takes approximately 45-60 minutes to administer. Weighted performance across four of these domains - spontaneous speech, auditory verbal comprehension, repetition, and naming/word finding - yields a composite score, the WAB-R Aphasia Quotient (AQ). The WAB-R AQ is an impairment-based metric that reliably indexes aphasia severity across different aphasia subtypes. Range is 0 t0 100.
Measured: Baseline, post-treatment (on average 10 weeks)
Pyramids and Palm Trees Test (PAPT) 3 Pictures Version
The Pyramids and Palm Trees is a non-verbal (language-independent) semantic processing assessment that includes 3 pictures of which the person has to decide which two go together. There are 52 items in this test with a range of 1-52.
Measured: Baseline, post-treatment (on average 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study start20 Apr 2018
- Primary completion31 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Swathi Kiran, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916524
- Sponsor's protocol ID
- 4492E
- Other IDs
- U01DC014922-01A1
- Acronym
- PROCoM
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2016
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Russell-Meill M, Carpenter E, Marte MJ, Scimeca M, Penaloza C, Kiran S. Measurement of cross-language and cross-domain generalization following semantic feature-based anomia treatment in bilingual aphasia. Neuropsychol Rehabil. 2026 Apr;36(3):544-570. doi: 10.1080/09602011.2025.2522196. Epub 2025 Jun 26.
PubMed 40571559Penaloza C, Dekhtyar M, Scimeca M, Carpenter E, Mukadam N, Kiran S. Predicting treatment outcomes for bilinguals with aphasia using computational modeling: Study protocol for the PROCoM randomised controlled trial. BMJ Open. 2020 Nov 18;10(11):e040495. doi: 10.1136/bmjopen-2020-040495.
PubMed 33208330
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Trial Investigating the Use of Computational Modeling to Predict Rehabilitation Outcomes in Bilingual Aphasia
- ClinicalTrials.gov ID
- NCT02916524
- Acronym / sponsor ID
- PROCoM / 4492E
- Conditions
- Aphasia
- Keywords
- Aphasia, Bilingualism, Language therapy, Rehabilitation of speech and language disorders, Speech-language pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Sep 2016 (estimated)
- Results
- Posted 5 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to implement a computational model that can predict and optimize training and cross-language generalization patterns for bilingual persons with aphasia (BPA). The proposed work will determine the best possible treatment program for each individual patient even before they are rehabilitated. In addition, the computational model allows specification of variables such as age of acquisition, language exposure/proficiency, impairment and their systematic influence on a range of language rehabilitation outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Model-based | Experimental | Behavioral: Semantic Feature Analysis (SFA)Semantic Feature Analysis training will be provided in the language that was selected by the computational model. |
| Model-opposite | Active comparator | Behavioral: Semantic Feature Analysis (SFA)Semantic Feature Analysis training will be provided in the language opposite to that which was selected by the computational model. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Any number of years of education
- Bilingual: speaking both Spanish and English (or Chinese and English) with any degree of language proficiency prior to stroke
- Aphasia secondary to a left-hemisphere stroke (diagnosed by a neurologist on the basis of clinical CT/MRI imaging or medical reports)
- Aphasia resulting from stroke or dementia
- Naming deficits must be present with concurrent lexical/semantic impairment
Key exclusion criteria (9 listed)
- Premorbid history of speech/language disorder
- Proficient in more than just Spanish and English (or Chinese and English)
- Overt, behaviorally noticeable, attentional limitations that interfere with completing the experimental tasks
- Active medical disease that may compromise participation (e.g., cancer undergoing acute treatment, unstable diabetes, renal or hepatic insufficiency, fluctuating systemic immunological disease such as systemic lupus erythematosis, etc.)
- Currently taking medications that are known to exert significant effects on cognitive processes, such as neuroleptics, steroids, anticholinesterase inhibitors, etc.
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 |
|---|---|---|
| Semantic Feature Analysis (SFA)SFA training entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, action associated with item). Treatment is applied to a set of items in the context of single-subject, multiple baseline designs so that replication of treatment effects could be evaluated within and across participants. Treatment will be administered two times per week until prescribed accuracy levels were met during treatment probes or a maximum number of treatment sessions was completed. | Behavioural | Model-based, Model-opposite |
Primary outcome
Word Retrieval Accuracy in English and Spanish
Time frame: Through study completion, an average of 10 weeks
Accuracy of naming black and white pictures that are both trained and untrained in English and Spanish will be assessed in naming tests. These tests were conducted repeatedly throughout the study, from baseline (prior to treatment) to the end of treatment. All naming responses were scored using as correct or incorrect. Proportion accuracy was calculated for each set of items for every testing session. Baseline scores were compared to end of treatment scores to obtain individual effect sizes for each sets of items for each participant.
4 secondary outcomes
Psycholinguistic Assessments of Language Processing in Aphasia (PALPA) in Both Languages
Time frame: Baseline, post-treatment (on average 10 weeks)
Boston Naming Test (BNT) in Both Languages
Time frame: Baseline, post-treatment (on average 10 weeks)
Western Aphasia Battery (WAB-R) in Both Languages
Time frame: Baseline, post-treatment (on average 10 weeks)
Pyramids and Palm Trees Test (PAPT) 3 Pictures Version
Time frame: Baseline, post-treatment (on average 10 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40571559Russell-Meill M, Carpenter E, Marte MJ, Scimeca M, Penaloza C, Kiran S. Measurement of cross-language and cross-domain generalization following semantic feature-based anomia treatment in bilingual aphasia. Neuropsychol Rehabil. 2026 Apr;36(3):544-570. doi: 10.1080/09602011.2025.2522196. Epub 2025 Jun 26.
- Derived from this study: PubMed 33208330Penaloza C, Dekhtyar M, Scimeca M, Carpenter E, Mukadam N, Kiran S. Predicting treatment outcomes for bilinguals with aphasia using computational modeling: Study protocol for the PROCoM randomised controlled trial. BMJ Open. 2020 Nov 18;10(11):e040495. doi: 10.1136/bmjopen-2020-040495.
- Aphasia Research Laboratory websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Aphasia
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
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. This study is not recruiting at the moment.
Swathi Kiran, PhD principal investigator
Boston University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semantic Feature Analysis (SFA) in people with Aphasia, run by Boston University Charles River Campus at 3 sites 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word Retrieval Accuracy in English and Spanish (time frame: Through study completion, an average of 10 weeks). 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 NCT02916524, which also lists 2 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 5 Nov 2026.