NCT06234059

Brief Summary

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.

Trial Health

50
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
2mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jul 2025Jul 2026

First Submitted

Initial submission to the registry

January 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

July 29, 2025

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

January 22, 2024

Last Update Submit

July 24, 2025

Conditions

Keywords

speech motor controlvocal learning

Outcome Measures

Primary Outcomes (1)

  • Acoustic vowel space measures: AVS (acoustic vowel spacing)/VSA (vowel space area)

    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.

    up to 1 hour

Study Arms (1)

Healthy Adult Speakers

EXPERIMENTAL

healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+

Device: TMSBehavioral: Speaking Tasks

Interventions

TMSDEVICE

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.

Also known as: transcranial magnetic stimulation (continuous and intermittent theta-burst stimulation), electromyography (EMG)
Healthy Adult Speakers
Speaking TasksBEHAVIORAL

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.

Healthy Adult Speakers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking adults
  • normal hearing and speech
  • no history of stroke or neurological conditions

You may not qualify if:

  • 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)
  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Links

MeSH Terms

Conditions

Speech

Interventions

Transcranial Magnetic StimulationElectromyography

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Officials

  • Carrie Niziolek, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 31, 2024

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 29, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Locations