NCT05723575

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

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 17, 2024

Completed
Last Updated

December 17, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

February 1, 2023

Results QC Date

November 21, 2024

Last Update Submit

November 21, 2024

Conditions

Keywords

speech motor controlvocal learning

Outcome Measures

Primary Outcomes (2)

  • Somatosensory Acuity: Spatial Amplitude Discrimination Threshold (SDT)

    The investigators will measure thresholds in spatial amplitude discrimination (SDT). These thresholds represent the smallest difference that participants can detect in the amplitude of vibration on the tongue. Vibratory stimulation is delivered by the corticalmetrics Brain Gauge device, which has two probes, one on the left and one on the right side of the tongue. 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. Tactile acuity measured in this way is used as a proxy for full somatosensation, given the difficulty in measuring proprioception in the oral system. Tactile acuity has been suggested to be important for speech production, as tactile contact is maintained parasagittally during vowel production and tactile deprivation leads to imprecise speech movements.

    up to 1 hour

  • Somatosensory Acuity: Temporal Discrimination Threshold (TDT)

    The investigators will measure thresholds in temporal discrimination (SDT). These thresholds represent the smallest difference that participants can detect in the timing of vibrations on the tongue. Vibratory stimulation is delivered by the corticalmetrics Brain Gauge device, which has two probes, one on the left and one on the right side of the tongue. 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. Tactile acuity measured in this way is used as a proxy for full somatosensation, given the difficulty in measuring proprioception in the oral system. Tactile acuity has been suggested to be important for speech production, as tactile contact is maintained parasagittally during vowel production and tactile deprivation leads to imprecise speech movements.

    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: somatosensory acuity measurement

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

Somatosensory acuity will be measured through a tactile discrimination task using the corticalmetrics Brain Gauge. Participants lightly press their tongue onto two vibrating probes and report which one vibrated first or with greater amplitude.

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)
  • +3 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

Results Point of Contact

Title
Carrie Niziolek, PhD
Organization
University of Wisconsin - Madison

Study Officials

  • Carrie Niziolek, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

February 1, 2023

First Posted

February 10, 2023

Study Start

November 18, 2022

Primary Completion

May 26, 2023

Study Completion

May 26, 2023

Last Updated

December 17, 2024

Results First Posted

December 17, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Locations