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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 8/25/2021 | Other Identifier | UW Madison | |
| A481800 | Other Identifier | UW Madison | |
| 1R01DC019134-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Adult Speakers | Experimental | healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | up to 1 hour |
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Inclusion Criteria (Control):
Exclusion Criteria:
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)
Additional exclusionary criteria for TMS:
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| Name | Affiliation | Role |
|---|---|---|
| Carrie Niziolek, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| Label | URL |
|---|---|
| Link to study record for experiment 5 \[NCT05286658\] | View source |
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15 people provided data for this study from November 2022 to May 2023
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Adult Speakers | healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ TMS: 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 measurement: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Adult Speakers | healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ TMS: 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 measurement: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | change in threshold (µm) | up to 1 hour |
|
Subjects participated in four sessions (each up to 4 hours) over the course of one month.
Minimal risk basic science study, no adverse event collection plan required
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Adult Speakers | healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ TMS: 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 measurement: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie Niziolek, PhD | University of Wisconsin - Madison | (608) 262-7583 | cniziolek@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2024 | Oct 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013060 | Speech |
| ID | Term |
|---|---|
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D004576 | Electromyography |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D004568 | Electrodiagnosis |
| D019937 | Diagnostic Techniques and Procedures |
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| somatosensory acuity measurement | Behavioral | 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. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Healthy Adult Speakers |
healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+ TMS: 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 measurement: 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. |
|
|
| Primary | 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. | Posted | Mean | Standard Error | change in threshold (ms) | up to 1 hour |
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| 0 |
| 15 |
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| 15 |
| 0 |
| 15 |
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| D003933 | Diagnosis |
| D009213 | Myography |
| Title | Measurements |
|---|---|
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| TDT (control) |
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