- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05286658
Behavioral and Neural Responses to External Alterations of Speech Variability
Behavioral and Neural Measures of Speech Motor Control
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria (Patients):
- English-speaking adults
diagnosed communicative disorder, target populations may include:
- stroke survivors with aphasia
- individuals with cerebellar ataxia
- individuals with parkinson's disease
- individuals who use cochlear implants to hear
- adults who stutter
Inclusion Criteria (Control):
- English-speaking adults
- normal hearing and speech
- no history of stroke or neurological conditions
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:
- Implanted paramagnetic materials (metal clips, plates, pacemakers, etc.)
- Head too large for MEG recording helmet
- Claustrophobia or intolerance of MRI scanner noise
- Low signal to noise ratio in pilot MEG recordings
- High levels of artifacts (eye-blinks, etc.)
- Inability to produce the speech sounds proposed with minimal movement
- Left-handedness
Additional exclusionary criteria if participating in transcranial magnetic stimulation (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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Healthy Adult Speakers
healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+
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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.
Other Names:
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.
Other Names:
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
Time Frame: 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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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".
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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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carrie Niziolek, PhD, University of Wisconsin, Madison
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2017-1128 MEG Imaging (Exp 5)
- Protocol Version 8/25/2021 (Other Identifier: UW Madison)
- A481800 (Other Identifier: UW Madison)
- 1R01DC019134-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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