Trial Outcomes & Findings for Behavioral and Neural Responses to External Alterations of Speech Variability (NCT NCT05286658)
NCT ID: NCT05286658
Last Updated: 2024-02-13
Results Overview
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".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Data were collected over 3 individual hour-long MEG sessions over 3 weeks (pre-test vs. post-test compared within the same session).
Results posted on
2024-02-13
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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17
|
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Overall Study
Inward Variability Condition
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15
|
|
Overall Study
Outward Variability Condition
|
15
|
|
Overall Study
Control Condition
|
15
|
|
Overall Study
Analysis Population
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15
|
|
Overall Study
COMPLETED
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15
|
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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.
|
|---|---|
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Overall Study
Head circumference too large for MEG scanner (exclusion criterion for the study).
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1
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Overall Study
Participant did not show SIS (the dependent measure), thus the hypothesis could not be assessed
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1
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Baseline Characteristics
Behavioral and Neural Responses to External Alterations of Speech Variability
Baseline characteristics by cohort
| Measure |
Healthy Adult Speakers
n=15 Participants
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.
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|---|---|
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Age, Continuous
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39.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
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Sex: Female, Male
Female
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9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Data were collected over 3 individual hour-long MEG sessions over 3 weeks (pre-test vs. post-test compared within the same session).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".
Outcome measures
| Measure |
Healthy Adult Speakers
n=15 Participants
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.
|
|---|---|
|
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
"In": inward variability condition
|
7.4 percent change (of z-score difference)
Standard Deviation 16.1
|
|
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
"Out": outward variability condition
|
-22.2 percent change (of z-score difference)
Standard Deviation 8.2
|
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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
"Control": control condition
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28.9 percent change (of z-score difference)
Standard Deviation 15.6
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Adverse Events
Healthy Adult Speakers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carrie Niziolek, PhD
University of Wisconsin - Madison
Phone: (608) 262-7583
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place