SpeechNCT06234059
Modulation of Sensory Acuity With Transcranial Magnetic Stimulation (TMS)
A study testing TMS and Speaking Tasks in people with Speech, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this research study is to understand how the brain processes and controls speech in healthy people. The investigators are doing this research because it will help identify the mechanisms that allow people to perceive their own speech errors and to learn new speech sounds, which may be applied to people… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech
- What is being tested?
- TMS and Speaking Tasks
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2025to Jul 2026
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking adults
- normal hearing and speech
- no history of stroke or neurological conditions
Who cannot join
- Native language other than English
- Any neurological disorders other than the disorder of interest
- Any history of hearing disorders
- Uncorrected vision problems that prevent participants from seeing visually-presented stimuli
- Significant cognitive impairments that prevent participants from carrying out the task or from giving informed consent
- Vulnerable populations (minors and prisoners)
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- Additional exclusionary criteria for TMS:
- Implanted paramagnetic materials (metal clips, plates, pacemakers, etc.)
- Increased risk in the event of a seizure
- Serious heart disease
- Increased intracranial pressure
- Pregnancy
- History of seizures
- Family history of epilepsy
- Epileptogenic medications
- Chronic or transient disruption of sleep (including jet lag)
- History of fainting
- Chronic or transient increase in stressful experiences
- Use of illegal drugs
- If the TMS visit involves a visual acuity task at the same time as TMS] Use of glasses at the research study visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral and Neural Measures of Speech Motor Control
The purpose of this research study is to understand how the brain processes and controls speech in healthy people. The investigators are doing this research because it will help identify the mechanisms that allow people to perceive their own speech errors and to learn new speech sounds, which may be applied to people who have communication disorders. 15 participants will be enrolled into this part of the study and can expect to be on study for 4 visits of 2-4 hours each.
Read the detailed description
The overall study (Establishing the clinical utility of sensorimotor adaptation for speech rehabilitation) aims to understand how cognitive, perceptual, and motor processes are integrated in the control of speech movements. The investigators study how this complex skill is performed in healthy speakers to understand how this system functions, how this skill relates to the perception of speech, and what role different parts of the brain play in this process. Different studies look at how speech motor control is executed, maintained, and changed. Overall, the study will recruit 329 participants over the course of 5 years. Participants can expect to be on study for up to 3 weeks.
The entire study is composed of 8 experiments and 6 interventions. The present record represents the experiments involving transcranial magnetic stimulation (TMS), i.e. Experiment 8: Modulating sensorimotor adaptation through TMS to somatosensory cortex.
This paradigm uses theta-burst transcranial magnetic stimulation (tbTMS) to modulate the excitability of sensory cortices to examine the effect on sensory acuity and sensorimotor adaptation. Participants will complete three total sessions targeting primary somatosensory cortex (S1): one using intermittent theta-burst stimulation (iTBS), one using continuous theta-burst stimulation (cTBS), and one with sham stimulation.
The effect of the stimulation on somatosensory adaptation will be measured using a vowel centralization feedback perturbation experiment: after stimulation, participants will produce words under conditions of altered auditory feedback, and the investigators will measure changes in produced vowels as a result of these alterations.
- Conditions
- Speech
- Being tested
- TMS, Speaking Tasks
- Keywords
- speech motor control, vocal learning
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Also called transcranial magnetic stimulation (continuous and intermittent theta-burst stimulation), electromyography (EMG)
This paradigm uses theta-burst transcranial magnetic stimulation (tbTMS) to modulate the excitability of sensory cortices to examine the effect on sensory acuity and sensorimotor adaptation. Participants will complete three total sessions targeting primary somatosensory cortex (S1): one using intermittent theta-burst stimulation (iTBS), one using continuous theta-burst stimulation (cTBS), and one with sham stimulation.
Speaking TasksBehavioural
Participants will produce four training words under a vowel centralization feedback paradigm in which auditory feedback is altered. The investigators will measure changes in produced vowels as a result of the altered feedback in concert with the different stimulation regimes described in the TMS intervention.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Speakers | Experimental | healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ Receives: Device: TMS; Behavioral: Speaking Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic vowel space measures: AVS (acoustic vowel spacing)/VSA (vowel space area)
For speech production tasks, the primary acoustic measure will be adaptation to the altered feedback, defined here as increases in AVS (average vowel spacing), the mean of pairwise formant distances between vowels. The investigators will also include a global measure of working vowel space, the quadrilateral vowel space area (qVSA). qVSA measures the area (in Hz^2) between the F1/F2 coordinates of the corner vowels. Both the more local AVS and more global qVSA have been linked to speech intelligibility in various types of dysarthria.
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Why it stopped: Another research group ran a similar study and reported results
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 University of Wisconsin, MadisonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Carrie Niziolek, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234059
- Sponsor's protocol ID
- 2017-1128 TMS (Exp 8)
- Other IDs
- 1R01DC019134-01A1, Protocol Version 4/29/2025, A481800
- Status last verified
- Sep 2024
- First submitted
- 22 Jan 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Neural Measures of Speech Motor Control
- ClinicalTrials.gov ID
- NCT06234059
- Acronym / sponsor ID
- 2017-1128 TMS (Exp 8)
- Conditions
- Speech
- Keywords
- speech motor control, vocal learning
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Another research group ran a similar study and reported results
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 31 Jan 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 purpose of this research study is to understand how the brain processes and controls speech in healthy people. The investigators are doing this research because it will help identify the mechanisms that allow people to perceive their own speech errors and to learn new speech sounds, which may be applied to people who have communication disorders. 15 participants will be enrolled into this part of the study and can expect to be on study for 4 visits of 2-4 hours each.
Detailed description
The overall study (Establishing the clinical utility of sensorimotor adaptation for speech rehabilitation) aims to understand how cognitive, perceptual, and motor processes are integrated in the control of speech movements. The investigators study how this complex skill is performed in healthy speakers to understand how this system functions, how this skill relates to the perception of speech, and what role different parts of the brain play in this process. Different studies look at how speech motor control is executed, maintained, and changed. Overall, the study will recruit 329 participants over the course of 5 years. Participants can expect to be on study for up to 3 weeks.
The entire study is composed of 8 experiments and 6 interventions. The present record represents the experiments involving transcranial magnetic stimulation (TMS), i.e. Experiment 8: Modulating sensorimotor adaptation through TMS to somatosensory cortex.
This paradigm uses theta-burst transcranial magnetic stimulation (tbTMS) to modulate the excitability of sensory cortices to examine the effect on sensory acuity and sensorimotor adaptation. Participants will complete three total sessions targeting primary somatosensory cortex (S1): one using intermittent theta-burst stimulation (iTBS), one using continuous theta-burst stimulation (cTBS), and one with sham stimulation.
The effect of the stimulation on somatosensory adaptation will be measured using a vowel centralization feedback perturbation experiment: after stimulation, participants will produce words under conditions of altered auditory feedback, and the investigators will measure changes in produced vowels as a result of these alterations.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Speakers | Experimental | Device: TMS, Behavioral: Speaking Taskshealthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking adults
- normal hearing and speech
- no history of stroke or neurological conditions
Key exclusion criteria (20 listed)
- Native language other than English
- Any neurological disorders other than the disorder of interest
- Any history of hearing disorders
- Uncorrected vision problems that prevent participants from seeing visually-presented stimuli
- Significant cognitive impairments that prevent participants from carrying out the task or from giving informed consent
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 |
|---|---|---|
| TMSAlso: transcranial magnetic stimulation (continuous and intermittent theta-burst stimulation), electromyography (EMG)This paradigm uses theta-burst transcranial magnetic stimulation (tbTMS) to modulate the excitability of sensory cortices to examine the effect on sensory acuity and sensorimotor adaptation. Participants will complete three total sessions targeting primary somatosensory cortex (S1): one using intermittent theta-burst stimulation (iTBS), one using continuous theta-burst stimulation (cTBS), and one with sham stimulation. | Device | Healthy Adult Speakers |
| Speaking TasksParticipants will produce four training words under a vowel centralization feedback paradigm in which auditory feedback is altered. The investigators will measure changes in produced vowels as a result of the altered feedback in concert with the different stimulation regimes described in the TMS intervention. | Behavioural | Healthy Adult Speakers |
Primary outcome
Acoustic vowel space measures: AVS (acoustic vowel spacing)/VSA (vowel space area)
Time frame: up to 1 hour
For speech production tasks, the primary acoustic measure will be adaptation to the altered feedback, defined here as increases in AVS (average vowel spacing), the mean of pairwise formant distances between vowels. The investigators will also include a global measure of working vowel space, the quadrilateral vowel space area (qVSA). qVSA measures the area (in Hz^2) between the F1/F2 coordinates of the corner vowels. Both the more local AVS and more global qVSA have been linked to speech intelligibility in various types of dysarthria.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Link to study record for experiment 7 \[NCT05723575\]Link provided by the sponsor.
- Link to study record for experiment 5 \[NCT05286658\]Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Speech
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
Not yet recruitingObservational study
IN-TALK: Co-producing a Hospice Intimacy Support Toolkit in England
Communication About Intimacy Needs in Hospice and Palliative Care
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Developmental Dyslexia, Reading Problem
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.
Carrie Niziolek, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS and Speaking Tasks in people with Speech, run by University of Wisconsin, Madison 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 20 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: withdrawn, as of the sponsor's last update on 29 Jul 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Acoustic vowel space measures: AVS (acoustic vowel spacing)/VSA (vowel space area) (time frame: up to 1 hour). 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 29 Jul 2025.