SpeechNCT06467292
Speech Motor Learning and Retention (Master Protocol)
A study testing continuous theta-burst stimulation (cTBS), Adaptation and Single pulse Transcranial magnetic stimulation (TMS) in people with Speech, run by Yale University at 1 site in United States.
Trial summary
The overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech
- What is being tested?
- continuous theta-burst stimulation (cTBS), Adaptation and Single pulse Transcranial magnetic stimulation (TMS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 31 May 2029
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluent English speakers
- Right-handed
- Normal hearing
- No speech disorder or reading disability
Who cannot join
- Cardiac pacemaker
- Aneurysm clip
- Heart or Vascular clip
- Prosthetic valve
- Metal implants
- Metal in brain, skull, or spinal cord
Show all 12Show fewer
- Implanted neurostimulator
- Medication infusion device
- Cochlear implant or tinnitus (ringing in ears)
- Personal and/or family history of epilepsy or other neurological disorders or history of head concussion
- Psychoactive medications
- Pregnancy
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
Yale Child Study Center
New Haven, Connecticut, 06520
About this study
Official title: Sensorimotor Basis of Speech Motor Learning and Retention
The overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well.
Read the detailed description
Aim 1 involves tests of speech motor memory retention following disruption of left hemisphere brain activity in either auditory, somatosensory or motor cortex or to a control site (hand area motor cortex right hemisphere). Continuous theta-burst stimulation (cTBS) is delivered following adaptation to altered auditory feedback to assess its effects on the retention of new learning.
Aim 2 assesses the temporal order in which plasticity occurs in cortical motor and sensory brain areas during speech motor learning.
In Aim 3, resting-state fMRI will be interleaved with speech motor adaptation. For information specific to each aim, please refer to the below corresponding, separate, clinicaltrials.gov records: unique IDs: 2000037622_a for Aim 1, 2000037622_b for Aim 2 and 2000037622_c for Aim 3.
- Conditions
- Speech
- Being tested
- continuous theta-burst stimulation (cTBS), Adaptation, Single pulse Transcranial magnetic stimulation (TMS), fMRI
- Keywords
- Speech Motor Learning, Retention
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous theta-burst stimulation (cTBS)Device
cTBS stimulation will be applied to different areas of the brain following learning. Stimulation will take place following learning in order to block motor memory retention.
AdaptationBehavioural
Auditory adaptation in speech
Single pulse Transcranial magnetic stimulation (TMS)Device
TMS will be delivered 10 times in each motor evoked potentials (MEP) recording block.
fMRIDevice
To assess functional connectivity patterns between regions that predict learning.
| Study group | Role | What they receive |
|---|---|---|
| Speech Motor Learning and Retention Aim 1 | Experimental | Aim 1: Participants will perform learning tasks while receiving altered/unaltered auditory feedback with cTBS applied to the appropriate area of the brain following learning. Retention of learning is assessed 24 hours later. Receives: Device: continuous theta-burst stimulation (cTBS); Behavioral: Adaptation |
| Speech Motor Learning and Retention Aim 2 | Experimental | Aim 2: Participants will perform learning tasks combined with shifted auditory feedback. Motor cortical excitability will be measured using single-pulse TMS to elicit motor evoked potentials. Receives: Behavioral: Adaptation; Device: Single pulse Transcranial magnetic stimulation (TMS) |
| Speech Motor Learning and Retention Aim 3 | Experimental | Aim 3: Participants will have fMRI with behavioral measures of speech motor learning. Receives: Behavioral: Adaptation; Device: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech motor learning
Audapter software will be used to alter the first and second formant frequencies of the spoken words and this is played back to subjects through headphones. Subjects will be tested both with unaltered feedback and with abruptly introduced frequency shifts.The change in the first (F1) and second format frequency (F2) values will be assessed using Praat.
Measured: Performance as measured at the end of learning (30 minute session)
Retention of learning
The retention of adaptation to altered auditory feedback (and relearning) will be quantified in terms of F1 and F2 frequency shifts (relative to pre-training baseline). Larger values indicate more complete relearning or retention.
Measured: 24 hours after learning (re-test lasts 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Oct 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpeechStudies of the same condition, open and under way.
- More trials run by Yale 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
- Model description
- Healthy right-handed adults with normal hearing will be recruited in equal number from both sexes. All participants will be fluent English speakers.
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- David Ostry, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467292
- Sponsor's protocol ID
- 2000037622
- Other IDs
- 1R01DC022097-01A1
- Status last verified
- Aug 2026
- First submitted
- 13 Jun 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Basis of Speech Motor Learning and Retention
- ClinicalTrials.gov ID
- NCT06467292
- Acronym / sponsor ID
- 2000037622
- Conditions
- Speech
- Keywords
- Speech Motor Learning, Retention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 21 Jun 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 overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well.
Detailed description
Aim 1 involves tests of speech motor memory retention following disruption of left hemisphere brain activity in either auditory, somatosensory or motor cortex or to a control site (hand area motor cortex right hemisphere). Continuous theta-burst stimulation (cTBS) is delivered following adaptation to altered auditory feedback to assess its effects on the retention of new learning.
Aim 2 assesses the temporal order in which plasticity occurs in cortical motor and sensory brain areas during speech motor learning.
In Aim 3, resting-state fMRI will be interleaved with speech motor adaptation. For information specific to each aim, please refer to the below corresponding, separate, clinicaltrials.gov records: unique IDs: 2000037622_a for Aim 1, 2000037622_b for Aim 2 and 2000037622_c for Aim 3.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Healthy right-handed adults with normal hearing will be recruited in equal number from both sexes. All participants will be fluent English speakers.
| Arm | Type | Receives |
|---|---|---|
| Speech Motor Learning and Retention Aim 1 | Experimental | Device: continuous theta-burst stimulation (cTBS), Behavioral: AdaptationAim 1: Participants will perform learning tasks while receiving altered/unaltered auditory feedback with cTBS applied to the appropriate area of the brain following learning. Retention of learning is assessed 24 hours later. |
| Speech Motor Learning and Retention Aim 2 | Experimental | Behavioral: Adaptation, Device: Single pulse Transcranial magnetic stimulation (TMS)Aim 2: Participants will perform learning tasks combined with shifted auditory feedback. Motor cortical excitability will be measured using single-pulse TMS to elicit motor evoked potentials. |
| Speech Motor Learning and Retention Aim 3 | Experimental | Behavioral: Adaptation, Device: fMRIAim 3: Participants will have fMRI with behavioral measures of speech motor learning. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fluent English speakers
- Right-handed
- Normal hearing
- No speech disorder or reading disability
Key exclusion criteria (12 listed)
- Cardiac pacemaker
- Aneurysm clip
- Heart or Vascular clip
- Prosthetic valve
- Metal implants
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 |
|---|---|---|
| continuous theta-burst stimulation (cTBS)cTBS stimulation will be applied to different areas of the brain following learning. Stimulation will take place following learning in order to block motor memory retention. | Device | Speech Motor Learning and Retention Aim 1 |
| AdaptationAuditory adaptation in speech | Behavioural | Speech Motor Learning and Retention Aim 1, Speech Motor Learning and Retention Aim 2, Speech Motor Learning and Retention Aim 3 |
| Single pulse Transcranial magnetic stimulation (TMS)TMS will be delivered 10 times in each motor evoked potentials (MEP) recording block. | Device | Speech Motor Learning and Retention Aim 2 |
| fMRITo assess functional connectivity patterns between regions that predict learning. | Device | Speech Motor Learning and Retention Aim 3 |
Primary outcome
Speech motor learning
Time frame: Performance as measured at the end of learning (30 minute session)
Audapter software will be used to alter the first and second formant frequencies of the spoken words and this is played back to subjects through headphones. Subjects will be tested both with unaltered feedback and with abruptly introduced frequency shifts.The change in the first (F1) and second format frequency (F2) values will be assessed using Praat.
Retention of learning
Time frame: 24 hours after learning (re-test lasts 30 minutes)
The retention of adaptation to altered auditory feedback (and relearning) will be quantified in terms of F1 and F2 frequency shifts (relative to pre-training baseline). Larger values indicate more complete relearning or retention.
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 18 Aug 2026.
- 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.
David Ostry principal investigator
Yale 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 continuous theta-burst stimulation (cTBS), Adaptation and Single pulse Transcranial magnetic stimulation (TMS) in people with Speech, run by Yale 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 4 inclusion and 12 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 18 Aug 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 Michael Stern (2038656163, michael.stern@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech motor learning (time frame: Performance as measured at the end of learning (30 minute session)). 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 18 Aug 2026.