- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06234059
Modulation of Sensory Acuity With Transcranial Magnetic Stimulation (TMS)
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 transcranial magnetic stimulation (TMS), i.e. Experiment 8: Modulating sensorimotor adaptation through TMS to somatosensory cortex.
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 somatosensory adaptation will be measured using a vowel centralization feedback perturbation experiment: after stimulation, participants will produce words under conditions of altered auditory feedback, and the investigators will measure changes in produced vowels as a result of these alterations.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carrie Niziolek, PhD
- Phone Number: 608-890-0192
- Email: cniziolek@wisc.edu
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53705
- University of Wisconsin
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Contact:
- Chris Naber
- Phone Number: 608-262-5776
- Email: speechmotor@waisman.wisc.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 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
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+
|
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.
Other Names:
Participants will produce four training words under a vowel centralization feedback paradigm in which auditory feedback is altered.
The investigators will measure changes in produced vowels as a result of the altered feedback in concert with the different stimulation regimes described in the TMS intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acoustic vowel space measures: AVS (acoustic vowel spacing)/VSA (vowel space area)
Time Frame: up to 1 hour
|
For speech production tasks, the primary acoustic measure will be adaptation to the altered feedback, defined here as increases in AVS (average vowel spacing), the mean of pairwise formant distances between vowels.
The investigators will also include a global measure of working vowel space, the quadrilateral vowel space area (qVSA).
qVSA measures the area (in Hz^2) between the F1/F2 coordinates of the corner vowels.
Both the more local AVS and more global qVSA have been linked to speech intelligibility in various types of dysarthria.
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up to 1 hour
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carrie Niziolek, PhD, University of Wisconsin, Madison
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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 TMS (Exp 8)
- 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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