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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 3-4 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 magnetoencephalographic (MEG) imaging, i.e. Experiment 5: Behavioral and neural responses to external alterations of speech variability.
This paradigm modulates the perceived speech variability of participants through three different altered auditory feedback sessions: an inward-pushing feedback perturbation that decreases perceived variability by playing back participants' speech closer to the center of their vowel distributions, an outward-pushing feedback perturbation that increases perceived variability by playing back participants' speech farther from the center of their vowel distributions, and a normal feedback condition in which speech feedback is played back without perturbation. Participants will complete this paradigm during MEG imaging, which will noninvasively measure auditory cortical activity evoked during speech production and playback.
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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 |
|---|---|---|---|---|
| MEG/EEG | Behavioral | The participant will sit still while their head is slid into the helmet-shaped bottom of the MEG device. The MEG contains sensors that passively detect weak magnetic fields outside the head produced by brain activity. The computer records the brain's electrical activity on the screen as wavy lines. The investigators will also ask you to wear sensors to capture eye-blinks (electrooculogram) and heartbeats (electrocardiogram) to facilitate removal from the MEG signal during analysis. Participant will sit in front of a projector screen and be asked to put on a pair of headphones. Participant will be shown real words or nonsense words to read, the investigators may play sounds through headphones for the participant to repeat. Participant speech will be recorded by a microphone. The investigators may ask the participant to identify what they heard by pressing a button on a button-box. These tasks are expected to take about one hour to complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Speaking-Induced Suppression (SIS) Change, Defined as the Percent Change of SIS (the Z-score Difference in Average M100 Amplitude in the Speak Condition Compared With the Listen Condition) From Baseline to Test Phases | The dependent measure is the speaking-induced suppression (SIS) defined as the z-score difference in average M100 amplitude in the speak condition compared with the listen condition. The M100 peak is defined as the peak activity between 75 and 150 ms after stimulus onset; peaks will be confirmed by visual inspection. The percent change in this SIS from the pre-test (baseline phase at the beginning of the MEG scan) to the post-test (test phase at the end of the MEG scan) is evaluated for each of three visits: "in", "out", and "control". | Data were collected over 3 individual hour-long MEG sessions over 3 weeks (pre-test vs. post-test compared within the same session). |
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Inclusion Criteria (Patients):
English-speaking adults
diagnosed communicative disorder, target populations may include:
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 if participating in neuroimaging:
Additional exclusionary criteria if participating in transcranial magnetic stimulation (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 | ||
| Medical College of Wisconsin |
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| Label | URL |
|---|---|
| Link to study record for experiment 7 \[NCT05723575\] | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Adult Speakers | Healthy adult participants across the lifespan. The participant will sit still while their head is slid into the helmet-shaped bottom of the MEG device. The MEG contains sensors that passively detect weak magnetic fields outside the head produced by brain activity. The computer records the brain's electrical activity on the screen as wavy lines. Participant will sit in front of a projector screen and be asked to put on a pair of headphones and be asked to read words or repeat sounds into a microphone. These tasks are expected to take about one hour to complete. The participant will undergo MRI scans and be able to hear and speak to the research staff at all times during the MRI procedures. The MRI test will take about 15 minutes. Speaking Tasks: The participant may be asked to perform some of the tasks from MEG again, this time outside of the scanner. These tasks are expected to take about one hour to complete. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants with measurable neural suppression (relevant outcome measure)
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Adult Speakers | Healthy adult participants across the lifespan. Interventions: This paradigm modulates the perceived speech variability of participants through three different altered auditory feedback sessions: an inward-pushing feedback perturbation that decreases perceived variability by playing back participants' speech closer to the center of their vowel distributions, an outward-pushing feedback perturbation that increases perceived variability by playing back participants' speech farther from the center of their vowel distributions, and a normal feedback condition in which speech feedback is played back without perturbation. The participants completed all three sessions during magnetoencephalographic (MEG) imaging, which noninvasively measured auditory cortical activity evoked during speech production and playback. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Speaking-Induced Suppression (SIS) Change, Defined as the Percent Change of SIS (the Z-score Difference in Average M100 Amplitude in the Speak Condition Compared With the Listen Condition) From Baseline to Test Phases | The dependent measure is the speaking-induced suppression (SIS) defined as the z-score difference in average M100 amplitude in the speak condition compared with the listen condition. The M100 peak is defined as the peak activity between 75 and 150 ms after stimulus onset; peaks will be confirmed by visual inspection. The percent change in this SIS from the pre-test (baseline phase at the beginning of the MEG scan) to the post-test (test phase at the end of the MEG scan) is evaluated for each of three visits: "in", "out", and "control". | Posted | Mean | Standard Deviation | percent change (of z-score difference) | Data were collected over 3 individual hour-long MEG sessions over 3 weeks (pre-test vs. post-test compared within the same session). |
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Subjects participated in four sessions (3 1-hour MEG scans and 1 1-hour behavioral visit) 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. | 0 |
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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, 2023 | Jul 18, 2023 | 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 |
|---|---|
| D015225 | Magnetoencephalography |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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| MRI | Behavioral | An MRI is a test that uses a magnetic field and pulses of radio wave energy to make pictures of organs and structures inside the body. The participant will be able to hear and speak to the research staff at all times during the MRI procedures. The MRI test will take about 15 minutes. |
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| Speaking Tasks | Behavioral | The participant may be asked to perform some of the tasks from MEG again, this time outside of the scanner. As before, the participant may see real words or nonsense words to read, and the investigators may play sounds through headphones and ask the participant to repeat them. Participant speech will be recorded by a microphone. The investigators may ask the participant to identify what they heard by pressing a button on a button-box. These tasks are expected to take about one hour to complete. |
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| Milwaukee |
| Wisconsin |
| 53226 |
| United States |
| 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 participants across the lifespan. The participant will sit still while their head is slid into the helmet-shaped bottom of the MEG device. The MEG contains sensors that passively detect weak magnetic fields outside the head produced by brain activity. The computer records the brain's electrical activity on the screen as wavy lines. Participant will sit in front of a projector screen and be asked to put on a pair of headphones and be asked to read words or repeat sounds into a microphone. These tasks are expected to take about one hour to complete. The participant will undergo MRI scans and be able to hear and speak to the research staff at all times during the MRI procedures. The MRI test will take about 15 minutes. Speaking Tasks: The participant may be asked to perform some of the tasks from MEG again, this time outside of the scanner. These tasks are expected to take about one hour to complete. |
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|
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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| D060306 | Magnetometry |
| D008919 | Investigative Techniques |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |