Healthy SubjectsNCT06181149
Auditory Prediction and Error Evaluation in the Speech of Individuals Who Stutter
A study testing Delaying speech initiation, Auditory errors and pre-speech auditory modulation and Contributions of the speech premotor cortex to pre-speech auditory modulation in people with Healthy Subjects and Stuttering, Developmental, run by Arizona State University at 2 sites in United States.
Trial summary
Stuttering negatively impacts communication and reduces the overall quality of life and well-being of individuals who stutter. This study will provide a strong foundation for developing neural and behavioral interventions for stuttering. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Stuttering, Developmental
- What is being tested?
- Delaying speech initiation, Auditory errors and pre-speech auditory modulation and Contributions of the speech premotor cortex to pre-speech auditory modulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2024to 30 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- being a monolingual, native speaker of American English
- absence of developmental, psychological, neurological, or communication disorders (other than developmental stuttering) as confirmed by a certified research SLP
- normal (age-appropriate) binaural pure-tone hearing threshold (0.5-4k Hz; ≤25 dB HL for younger than 70 years, and ≤35 dB HL for older than 70 years)
- not taking any medications that affect the central nervous system
- absence of safety contra-indication for tDCS, TMS and MRI (for adults)
- scoring at the 20th percentile or higher on standardized speech-language tests (for children)
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Univeristy of Washington
Seattle, Washington, 98105
Ludo Max, 206-543-2674, LudoMax@uw.edu
Ludo Max, PhD
- Recruiting
Arizona State University
Tempe, Arizona, 85287
Ayoub Daliri, 480-727-8397, ayoub.daliri@asu.edu
Ayoub Daliri, PhD
About this study
Stuttering negatively impacts communication and reduces the overall quality of life and well-being of individuals who stutter. This study will provide a strong foundation for developing neural and behavioral interventions for stuttering. Participants will be asked to name pictures, read words/sentences silently or aloud, and listen to speech and nonspeech sounds while their speech, muscle, and brain signals are collected. Some participants may also receive brain stimulation while reading and speaking.
- Conditions
- Healthy Subjects, Stuttering, Developmental
- Being tested
- Delaying speech initiation, Auditory errors and pre-speech auditory modulation, Contributions of the speech premotor cortex to pre-speech auditory modulation, Delaying auditory feedback
- Keywords
- stuttering
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delaying speech initiationBehavioural
This intervention will examine the effects of misalignment between prediction and auditory feedback in participants. We will use transcranial magnetic stimulation to induce a temporal misalignment between prediction and auditory feedback while participants produce speech.
Auditory errors and pre-speech auditory modulationBehavioural
This intervention will examine the contributions of auditory errors to pre-speech auditory modulation. Participants will receive auditory perturbations while speaking, and we will collect their brain activities throughout the study.
Contributions of the speech premotor cortex to pre-speech auditory modulationBehavioural
This intervention will examine the effects of stimulation of the left ventral premotor cortex on pre-speech auditory modulation. Participants will receive electrical stimulation while speaking.
Delaying auditory feedbackBehavioural
This intervention will examine the effects of misalignment between prediction and auditory feedback in participants. We will use delayed auditory feedback to induce a temporal misalignment between prediction and auditory feedback while participants produce speech.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Behavioral: Delaying speech initiation |
| Group 2 | Experimental | Not described Receives: Behavioral: Auditory errors and pre-speech auditory modulation |
| Group 3 | Experimental | Not described Receives: Behavioral: Contributions of the speech premotor cortex to pre-speech auditory modulation |
| Group 4 | Experimental | Not described Receives: Behavioral: Delaying auditory feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain activity before and during speaking
Participants will hear speech sounds in each trial before speaking or reading words. Participants' brain activity will be recorded while completing the speaking or reading tasks. The investigators will measure how the participant's brain activity in response to the played sounds changes during speaking and reading tasks. For this purpose, the investigators will measure the amplitude of the brain activity (in microvolts; µV) measured using a commercial electroencephalography system. The amplitude (µV) of the brain signals will be examined both before speaking and during speaking at two time points.
Measured: within each session of the study that may last up to 2 hours
change in speech when participants experience auditory errors
In each trial, participants will experience an auditory error while they produce speech (e.g., they may say "head" but hear "had"). The investigators will measure how the participants' speech changes due to auditory errors that they experience in the current trial. For this p[purpose, the investigators will use commercial microphones to record speech signals and then examine the amplitude of the speech in specific frequency ranges (measured in Hertz; Hz). The frequencies (Hz) of speech in trials with auditory errors will be compared with those without auditory errors.
Measured: within each session of the study that may last up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Jan 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Arizona State 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181149
- Sponsor's protocol ID
- R01DC020162
- Other IDs
- 1R01DC020162-01A1
- Status last verified
- Aug 2025
- First submitted
- 7 Dec 2023
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Prediction and Error Evaluation in the Speech of Individuals Who Stutter
- ClinicalTrials.gov ID
- NCT06181149
- Acronym / sponsor ID
- R01DC020162
- Conditions
- Healthy Subjects, Stuttering, Developmental
- Keywords
- stuttering
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- University of Washington, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 26 Dec 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.
Stuttering negatively impacts communication and reduces the overall quality of life and well-being of individuals who stutter. This study will provide a strong foundation for developing neural and behavioral interventions for stuttering. Participants will be asked to name pictures, read words/sentences silently or aloud, and listen to speech and nonspeech sounds while their speech, muscle, and brain signals are collected. Some participants may also receive brain stimulation while reading and speaking.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Delaying speech initiation |
| Group 2 | Experimental | Behavioral: Auditory errors and pre-speech auditory modulation |
| Group 3 | Experimental | Behavioral: Contributions of the speech premotor cortex to pre-speech auditory modulation |
| Group 4 | Experimental | Behavioral: Delaying auditory feedback |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- being a monolingual, native speaker of American English
- absence of developmental, psychological, neurological, or communication disorders (other than developmental stuttering) as confirmed by a certified research SLP
- normal (age-appropriate) binaural pure-tone hearing threshold (0.5-4k Hz; ≤25 dB HL for younger than 70 years, and ≤35 dB HL for older than 70 years)
- not taking any medications that affect the central nervous system
- absence of safety contra-indication for tDCS, TMS and MRI (for adults)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Delaying speech initiationThis intervention will examine the effects of misalignment between prediction and auditory feedback in participants. We will use transcranial magnetic stimulation to induce a temporal misalignment between prediction and auditory feedback while participants produce speech. | Behavioural | Group 1 |
| Auditory errors and pre-speech auditory modulationThis intervention will examine the contributions of auditory errors to pre-speech auditory modulation. Participants will receive auditory perturbations while speaking, and we will collect their brain activities throughout the study. | Behavioural | Group 2 |
| Contributions of the speech premotor cortex to pre-speech auditory modulationThis intervention will examine the effects of stimulation of the left ventral premotor cortex on pre-speech auditory modulation. Participants will receive electrical stimulation while speaking. | Behavioural | Group 3 |
| Delaying auditory feedbackThis intervention will examine the effects of misalignment between prediction and auditory feedback in participants. We will use delayed auditory feedback to induce a temporal misalignment between prediction and auditory feedback while participants produce speech. | Behavioural | Group 4 |
Primary outcome
Change in brain activity before and during speaking
Time frame: within each session of the study that may last up to 2 hours
Participants will hear speech sounds in each trial before speaking or reading words. Participants' brain activity will be recorded while completing the speaking or reading tasks. The investigators will measure how the participant's brain activity in response to the played sounds changes during speaking and reading tasks. For this purpose, the investigators will measure the amplitude of the brain activity (in microvolts; µV) measured using a commercial electroencephalography system. The amplitude (µV) of the brain signals will be examined both before speaking and during speaking at two time points.
change in speech when participants experience auditory errors
Time frame: within each session of the study that may last up to 2 hours
In each trial, participants will experience an auditory error while they produce speech (e.g., they may say "head" but hear "had"). The investigators will measure how the participants' speech changes due to auditory errors that they experience in the current trial. For this p[purpose, the investigators will use commercial microphones to record speech signals and then examine the amplitude of the speech in specific frequency ranges (measured in Hertz; Hz). The frequencies (Hz) of speech in trials with auditory errors will be compared with those without auditory errors.
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 21 Aug 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delaying speech initiation, Auditory errors and pre-speech auditory modulation and Contributions of the speech premotor cortex to pre-speech auditory modulation in people with Healthy Subjects and Stuttering, Developmental, run by Arizona State University 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 6 inclusion and 1 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 21 Aug 2025. 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?
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 Ayoub Daliri, PhD (4807278397, ayoub.daliri@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain activity before and during speaking (time frame: within each session of the study that may last up to 2 hours). 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 21 Aug 2025.