SpeechNCT05723575
Modulation of Sensory Acuity With Transcranial Magnetic Stimulation (TMS)
A study testing TMS and somatosensory acuity measurement 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 somatosensory acuity measurement
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2022to 26 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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)
Show all 19Show fewer
- 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
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 7: Using TMS to alter somatosensory acuity.
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 auditory acuity will be measured through a tactile discrimination task in which participants report the relative amplitude and/or timing of vibrating probes pressed lightly into the tongue using a custom device (a version of the Corticalmetrics Brain Gauge adapted to study the orofacial system).
- Conditions
- Speech
- Being tested
- TMS, somatosensory acuity measurement
- 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.
somatosensory acuity measurementBehavioural
Somatosensory acuity will be measured through a tactile discrimination task using the corticalmetrics Brain Gauge. Participants lightly press their tongue onto two vibrating probes and report which one vibrated first or with greater amplitude.
| 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: somatosensory acuity measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatosensory Acuity: Spatial Amplitude Discrimination Threshold (SDT)
The investigators will measure thresholds in spatial amplitude discrimination (SDT). These thresholds represent the smallest difference that participants can detect in the amplitude of vibration on the tongue. Vibratory stimulation is delivered by the corticalmetrics Brain Gauge device, which has two probes, one on the left and one on the right side of the tongue. 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.
Tactile acuity measured in this way is used as a proxy for full somatosensation, given the difficulty in measuring proprioception in the oral system. Tactile acuity has been suggested to be important for speech production, as tactile contact is maintained parasagittally during vowel production and tactile deprivation leads to imprecise speech movements.
Measured: up to 1 hour
Somatosensory Acuity: Temporal Discrimination Threshold (TDT)
The investigators will measure thresholds in temporal discrimination (SDT). These thresholds represent the smallest difference that participants can detect in the timing of vibrations on the tongue. Vibratory stimulation is delivered by the corticalmetrics Brain Gauge device, which has two probes, one on the left and one on the right side of the tongue. 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.
Tactile acuity measured in this way is used as a proxy for full somatosensation, given the difficulty in measuring proprioception in the oral system. Tactile acuity has been suggested to be important for speech production, as tactile contact is maintained parasagittally during vowel production and tactile deprivation leads to imprecise speech movements.
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 posted10 Feb 2023
- Study start18 Nov 2022
- Primary completion26 May 2023
- Study completion26 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 15 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
- NCT05723575
- Sponsor's protocol ID
- 2017-1128 TMS (Exp 7)
- Other IDs
- Protocol Version 8/25/2021, A481800, 1R01DC019134-01A1
- Status last verified
- Nov 2024
- First submitted
- 1 Feb 2023
- Last updated
- 17 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 Dec 2024. 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
- NCT05723575
- Acronym / sponsor ID
- 2017-1128 TMS (Exp 7)
- Conditions
- Speech
- Keywords
- speech motor control, vocal learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Posted 17 Dec 2024
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 7: Using TMS to alter somatosensory acuity.
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 auditory acuity will be measured through a tactile discrimination task in which participants report the relative amplitude and/or timing of vibrating probes pressed lightly into the tongue using a custom device (a version of the Corticalmetrics Brain Gauge adapted to study the orofacial system).
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: somatosensory acuity measurementhealthy 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 (19 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 |
| somatosensory acuity measurementSomatosensory acuity will be measured through a tactile discrimination task using the corticalmetrics Brain Gauge. Participants lightly press their tongue onto two vibrating probes and report which one vibrated first or with greater amplitude. | Behavioural | Healthy Adult Speakers |
Primary outcome
Somatosensory Acuity: Spatial Amplitude Discrimination Threshold (SDT)
Time frame: up to 1 hour
The investigators will measure thresholds in spatial amplitude discrimination (SDT). These thresholds represent the smallest difference that participants can detect in the amplitude of vibration on the tongue. Vibratory stimulation is delivered by the corticalmetrics Brain Gauge device, which has two probes, one on the left and one on the right side of the tongue. 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. Tactile acuity measured in this way is used as a proxy for full somatosensation, given the difficulty in measuring proprioception in the oral system. Tactile acuity has been suggested to be important for speech production, as tactile contact is maintained parasagittally during vowel production and tactile deprivation leads to imprecise speech movements.
Somatosensory Acuity: Temporal Discrimination Threshold (TDT)
Time frame: up to 1 hour
The investigators will measure thresholds in temporal discrimination (SDT). These thresholds represent the smallest difference that participants can detect in the timing of vibrations on the tongue. Vibratory stimulation is delivered by the corticalmetrics Brain Gauge device, which has two probes, one on the left and one on the right side of the tongue. 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. Tactile acuity measured in this way is used as a proxy for full somatosensation, given the difficulty in measuring proprioception in the oral system. Tactile acuity has been suggested to be important for speech production, as tactile contact is maintained parasagittally during vowel production and tactile deprivation leads to imprecise speech movements.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to study record for experiment 5 \[NCT05286658\]Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
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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. 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 somatosensory acuity measurement 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 19 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 17 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Somatosensory Acuity: Spatial Amplitude Discrimination Threshold (SDT) (time frame: up to 1 hour). 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 17 Dec 2024.