AphasiaNCT06323629
Effects of Recursive Self-feedback on Speech Production in Aphasia
A study testing Adaptive recursive self-feedback procedure and Non-adaptive recursive self-feedback procedure in people with Aphasia and Stroke, run by University of South Florida at 1 site in United States.
Trial summary
The goal of this clinical trial is to test the effects of recursive self-feedback procedures on spontaneous speech production in stroke survivors with impaired speech production (aphasia). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Adaptive recursive self-feedback procedure and Non-adaptive recursive self-feedback procedure
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2024to Dec 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6 months post left hemisphere stroke
- Aphasia due to left hemisphere stroke
- Dominant English speaker
Who cannot join
- Speech-language deficits due to neurological insults such as Parkinson's disease, neurodegenerative conditions etc.
- Uncorrected sensory impairments.
- Language comprehension impairment.
- Severe cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brain and Aphasia Recovery Lab, PCD 1030, Department of Communication Sciences and Disorders, University of South Florida
Tampa, Florida, 33620
Gerald C Imaezue, PhD, 8139742464, gimaezue@usf.edu
About this study
Official title: Recursive Self-feedback Procedures for Improving Spontaneous Speech Production in Patients With Chronic Aphasia
The goal of this clinical trial is to test the effects of recursive self-feedback procedures on spontaneous speech production in stroke survivors with impaired speech production (aphasia). The main question it aims to answer is:
- To what extent can stroke survivors with aphasia use their self-feedback alone to improve their spontaneous speech production?
Read more
Participants will be engaged in the following activities:
- They will perform language and cognitive tasks.
- Afterwards, they will receive treatments using tablets and headphones at no cost to them.
- The experimental treatments (recursive self-feedback procedures) entails responding to prompts, listening to playbacks of their speech response and attempt to minimize/correct the errors in the next attempt. This process will be repeated multiple times per prompt.
- The experimental treatments are two: an adaptive version that adapts the complexity of the treatment prompt and a non-adaptive version that does not adapt task complexity.
- Researchers will compare the experimental treatments to see if both have similar effects on improving spontaneous speech production.
- Being tested
- Adaptive recursive self-feedback procedure, Non-adaptive recursive self-feedback procedure
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive recursive self-feedback procedureBehavioural
The intervention uses self-feedback alone to improve speech production. It adapts the complexity of the treatment tasks.
Non-adaptive recursive self-feedback procedureBehavioural
The intervention uses self-feedback alone to improve speech production. However, it does not adapt the complexity of the treatment tasks.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive recursive self-feedback procedure | Experimental | Using a tablet, participants listen to speech playback of their response to a prompt and self-correct/minimize their speech errors in a subsequent attempt. This process is looped multiple times per prompt. It adapts across narrative prompts with low and high complexities. Receives: Behavioral: Adaptive recursive self-feedback procedure |
| Non-adaptive recursive self-feedback procedure | Experimental | Using a tablet, participants listen to speech playback of their response to a prompt and self-correct/minimize their speech errors in a subsequent attempt. This process is looped multiple times per prompt. However, it only uses narrative prompts with high complexity. Receives: Behavioral: Non-adaptive recursive self-feedback procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speaking rate
Correct words produced per minute
Measured: Within 1 week before treatment and within 1 week after treatment.
Speech initiation latency in milliseconds
Latency before retrieving the first correct word in an utterance.
Measured: Within 1 week before treatment and within 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 posted21 Mar 2024
- Study start29 Aug 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Smart Use of Technologies to Assess Real-world Outcomes
- Responsible party
- Sponsor
- Investigators
- Gerald C. Imaezue, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323629
- Sponsor's protocol ID
- STUDY006201
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will only be shared with approved members of the research team.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recursive Self-feedback Procedures for Improving Spontaneous Speech Production in Patients With Chronic Aphasia
- ClinicalTrials.gov ID
- NCT06323629
- Acronym / sponsor ID
- STUDY006201
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Center for Smart Use of Technologies to Assess Real-world Outcomes
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Mar 2024 (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 goal of this clinical trial is to test the effects of recursive self-feedback procedures on spontaneous speech production in stroke survivors with impaired speech production (aphasia). The main question it aims to answer is:
- To what extent can stroke survivors with aphasia use their self-feedback alone to improve their spontaneous speech production?
Participants will be engaged in the following activities:
- They will perform language and cognitive tasks.
- Afterwards, they will receive treatments using tablets and headphones at no cost to them.
- The experimental treatments (recursive self-feedback procedures) entails responding to prompts, listening to playbacks of their speech response and attempt to minimize/correct the errors in the next attempt. This process will be repeated multiple times per prompt.
- The experimental treatments are two: an adaptive version that adapts the complexity of the treatment prompt and a non-adaptive version that does not adapt task complexity.
- Researchers will compare the experimental treatments to see if both have similar effects on improving spontaneous speech production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive recursive self-feedback procedure | Experimental | Behavioral: Adaptive recursive self-feedback procedureUsing a tablet, participants listen to speech playback of their response to a prompt and self-correct/minimize their speech errors in a subsequent attempt. This process is looped multiple times per prompt. It adapts across narrative prompts with low and high complexities. |
| Non-adaptive recursive self-feedback procedure | Experimental | Behavioral: Non-adaptive recursive self-feedback procedureUsing a tablet, participants listen to speech playback of their response to a prompt and self-correct/minimize their speech errors in a subsequent attempt. This process is looped multiple times per prompt. However, it only uses narrative prompts with high complexity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 6 months post left hemisphere stroke
- Aphasia due to left hemisphere stroke
- Dominant English speaker
Key exclusion criteria (4 listed)
- Speech-language deficits due to neurological insults such as Parkinson's disease, neurodegenerative conditions etc.
- Uncorrected sensory impairments.
- Language comprehension impairment.
- Severe cognitive impairment.
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 |
|---|---|---|
| Adaptive recursive self-feedback procedureThe intervention uses self-feedback alone to improve speech production. It adapts the complexity of the treatment tasks. | Behavioural | Adaptive recursive self-feedback procedure |
| Non-adaptive recursive self-feedback procedureThe intervention uses self-feedback alone to improve speech production. However, it does not adapt the complexity of the treatment tasks. | Behavioural | Non-adaptive recursive self-feedback procedure |
Primary outcome
Speaking rate
Time frame: Within 1 week before treatment and within 1 week after treatment.
Correct words produced per minute
Speech initiation latency in milliseconds
Time frame: Within 1 week before treatment and within 1 week after treatment.
Latency before retrieving the first correct word in an utterance.
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 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will only be shared with approved members of the research team.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
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
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.
Gerald C. Imaezue, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive recursive self-feedback procedure and Non-adaptive recursive self-feedback procedure in people with Aphasia and Stroke, run by University of South Florida 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 3 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 14 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 Gerald C. Imaezue, PhD ((813)974-2464, gimaezue@usf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speaking rate (time frame: Within 1 week before treatment and within 1 week after treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.