AphasiaNCT03416738
Modeling Treated Recovery From Aphasia
A study testing Semantically focused treatment and Phonologically focused treatment in people with Aphasia and Stroke, run by University of South Carolina at 2 sites in United States.
Trial summary
Stroke is the leading cause of adult disability in the United States, and aphasia is common following a stroke to the left hemisphere of the brain. Aphasia therapy can improve aphasia recover; however, very little is known about how different patients respond to different types of treatments. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Aphasia, Stroke, Stroke, Ischemic
- What is being tested?
- Semantically focused treatment and Phonologically focused treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Aug 2016to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experienced a left hemisphere ischemic or hemorrhagic stroke At least 12 months post-stroke
- Primarily English speaker for the past 20 years
- Ability to provide informed written or verbal consent MRI-compatible (e.g., no metal implants, not claustrophobic)
Who cannot join
- History of a right hemisphere stroke (Bilateral stroke)
- Clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
- Severely limited speech production and/or auditory comprehension that interferes with adequate participation in the therapy provided
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: (C-STAR) Center for the Study of Aphasia Recovery Modeling Treated Recovery From Aphasia
Stroke is the leading cause of adult disability in the United States, and aphasia is common following a stroke to the left hemisphere of the brain. Aphasia therapy can improve aphasia recover; however, very little is known about how different patients respond to different types of treatments.
The purpose of this study is to understand how the following factors influence an individual's response to aphasia treatment: 1) biographical factors (e.g., age, education, gender), 2) post-stroke cognitive/linguistic abilities and learning potential, and 3) the location and extent of post-stroke brain damage. We are also interested in understanding the kinds of treatment materials that should be emphasized in speech/language treatment.
Overall, the goal of the current research is to inform the clinical management of post-stroke aphasia by identifying factors that can predict how an individual will respond to different treatment methods.
- Conditions
- Aphasia, Stroke, Stroke, Ischemic, Aphasia, Broca, Aphasia, Global, Aphasia, Mixed
- Being tested
- Semantically focused treatment, Phonologically focused treatment
- Medical subject headings
- Aphasia, Stroke, Ischemic Stroke, Aphasia, Broca, Aphasia, Wernicke, Aphasia, Conduction, Anomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semantically focused treatmentBehavioural
Tasks are as follows:
- Semantic feature analysis (SFA): For each pictured stimulus the patient is prompted to name the picture, and then to produce related words that represent features similar to the target word.
- Semantic barrier task: The goal is for one participant (e.g., patient) to describe each card so that the other participant (e.g., clinician) can guess the picture on the card. Participants are only allowed to describe the semantic features of the target and the clinician models the kinds of cues that are allowed.
- Verb network strengthening treatment (VNeST): This treatment targets lexical retrieval of verbs and their thematic nouns. The objective of VNeST is for the patient to generate verb-noun associates with the purpose of strengthening the connections between the verb and its uses.
These are tasks used in clinical aphasia rehabilitation.
Phonologically focused treatmentBehavioural
Tasks are as follows:
- Phonological (sound) components analysis task: Participants are to name a given picture and then to identify the sound features of the target words (e.g., first sound, last sound, and rhyme).
- Phonological production task: This tasks asks participants to sort and identify the sounds that make up a word. Various stages include identifying first sounds, last sounds, etc. Participants also work on blending sounds together to form words.
- The phonological judgment task: A computerized presentation of verbs and nouns where participants are required to judge whether pairs of words include similar phonological features.
These are tasks used in clinical aphasia rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Semantically focused treatment | Active comparator | This treatment will focus on improving word finding and comprehension of information. Receives: Behavioral: Semantically focused treatment |
| Phonologically focused treatment | Active comparator | This treatment will focus on training speech sound production, targeting overall production abilities. Receives: Behavioral: Phonologically focused treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Philadelphia Naming Test
Assesses the ability to name functional objects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start2 Aug 2016
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Julius Fridriksson, University of South Carolina
- Investigators
- Julius Fridriksson, PhD, CCC-SLP, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416738
- Sponsor's protocol ID
- Pro00053559
- Other IDs
- P50DC014664
- Status last verified
- Apr 2022
- First submitted
- 23 Jan 2018
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wilmskoetter J, Kristinsson S, Rangus I, Busby N, Rorden C, den Ouden D, Newman-Norlund R, Banister C, Riccardi N, Teghipco A, Newman-Norlund S, Fridriksson J, Bonilha L. Gene Expression-Based Lesion-Symptom Mapping: FOXP2 and Language Impairments after Stroke. J Neurosci. 2026 Jan 21;46(3):e0413252025. doi: 10.1523/JNEUROSCI.0413-25.2025.
PubMed 41203433Busby N, Wilmskoetter J, Gleichgerrcht E, Rorden C, Roth R, Newman-Norlund R, Hillis AE, Keller SS, de Bezenac C, Kristinsson S, Fridriksson J, Bonilha L. Advanced Brain Age and Chronic Poststroke Aphasia Severity. Neurology. 2023 Mar 14;100(11):e1166-e1176. doi: 10.1212/WNL.0000000000201693. Epub 2022 Dec 16.
PubMed 36526425
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (C-STAR) Center for the Study of Aphasia Recovery Modeling Treated Recovery From Aphasia
- ClinicalTrials.gov ID
- NCT03416738
- Acronym / sponsor ID
- Pro00053559
- Conditions
- Aphasia, Stroke, Stroke, Ischemic, Aphasia, Broca, Aphasia, Global, Aphasia, Mixed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 2 Aug 2016 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 31 Jan 2018 (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.
Stroke is the leading cause of adult disability in the United States, and aphasia is common following a stroke to the left hemisphere of the brain. Aphasia therapy can improve aphasia recover; however, very little is known about how different patients respond to different types of treatments.
The purpose of this study is to understand how the following factors influence an individual's response to aphasia treatment: 1) biographical factors (e.g., age, education, gender), 2) post-stroke cognitive/linguistic abilities and learning potential, and 3) the location and extent of post-stroke brain damage. We are also interested in understanding the kinds of treatment materials that should be emphasized in speech/language treatment.
Overall, the goal of the current research is to inform the clinical management of post-stroke aphasia by identifying factors that can predict how an individual will respond to different treatment methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semantically focused treatment | Active comparator | Behavioral: Semantically focused treatmentThis treatment will focus on improving word finding and comprehension of information. |
| Phonologically focused treatment | Active comparator | Behavioral: Phonologically focused treatmentThis treatment will focus on training speech sound production, targeting overall production abilities. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Experienced a left hemisphere ischemic or hemorrhagic stroke At least 12 months post-stroke
- Primarily English speaker for the past 20 years
- Ability to provide informed written or verbal consent MRI-compatible (e.g., no metal implants, not claustrophobic)
Key exclusion criteria (3 listed)
- History of a right hemisphere stroke (Bilateral stroke)
- Clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
- Severely limited speech production and/or auditory comprehension that interferes with adequate participation in the therapy provided
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 |
|---|---|---|
| Semantically focused treatmentTasks are as follows: 1. Semantic feature analysis (SFA): For each pictured stimulus the patient is prompted to name the picture, and then to produce related words that represent features similar to the target word. 2. Semantic barrier task: The goal is for one participant (e.g., patient) to describe each card so that the other participant (e.g., clinician) can guess the picture on the card. Participants are only allowed to describe the semantic features of the target and the clinician models the kinds of cues that are allowed. 3. Verb network strengthening treatment (VNeST): This treatment targets lexical retrieval of verbs and their thematic nouns. The objective of VNeST is for the patient to generate verb-noun associates with the purpose of strengthening the connections between the verb and its uses. These are tasks used in clinical aphasia rehabilitation. | Behavioural | Semantically focused treatment |
| Phonologically focused treatmentTasks are as follows: 1. Phonological (sound) components analysis task: Participants are to name a given picture and then to identify the sound features of the target words (e.g., first sound, last sound, and rhyme). 2. Phonological production task: This tasks asks participants to sort and identify the sounds that make up a word. Various stages include identifying first sounds, last sounds, etc. Participants also work on blending sounds together to form words. 3. The phonological judgment task: A computerized presentation of verbs and nouns where participants are required to judge whether pairs of words include similar phonological features. These are tasks used in clinical aphasia rehabilitation. | Behavioural | Phonologically focused treatment |
Primary outcome
Philadelphia Naming Test
Time frame: 6 months
Assesses the ability to name functional objects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Derived from this study: PubMed 41203433Wilmskoetter J, Kristinsson S, Rangus I, Busby N, Rorden C, den Ouden D, Newman-Norlund R, Banister C, Riccardi N, Teghipco A, Newman-Norlund S, Fridriksson J, Bonilha L. Gene Expression-Based Lesion-Symptom Mapping: FOXP2 and Language Impairments after Stroke. J Neurosci. 2026 Jan 21;46(3):e0413252025. doi: 10.1523/JNEUROSCI.0413-25.2025.
- Derived from this study: PubMed 36526425Busby N, Wilmskoetter J, Gleichgerrcht E, Rorden C, Roth R, Newman-Norlund R, Hillis AE, Keller SS, de Bezenac C, Kristinsson S, Fridriksson J, Bonilha L. Advanced Brain Age and Chronic Poststroke Aphasia Severity. Neurology. 2023 Mar 14;100(11):e1166-e1176. doi: 10.1212/WNL.0000000000201693. Epub 2022 Dec 16.
- Study websiteLink provided by the sponsor.
Related trials for Aphasia
Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
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.
Julius Fridriksson, PhD, CCC-SLP principal investigator
University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semantically focused treatment and Phonologically focused treatment in people with Aphasia and Stroke, run by University of South Carolina at 2 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 3 inclusion and 3 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 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Philadelphia Naming Test (time frame: 6 months). 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 NCT03416738, 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 28 Apr 2022.