NCT06492252

Brief Summary

The overall goal of this research is to test a new model of speech motor learning, whose central hypothesis is that learning and retention are associated with plasticity not only in motor areas of the brain but in auditory and somatosensory regions as well. The strategy for the proposed research is to identify individual brain areas that contribute causally to retention by disrupting their activity with transcranial magnetic stimulation (TMS). Investigators will also use functional magnetic resonance imaging (fMRI) which will enable identification of circuit-level activity which predicts either learning or retention of new movements, and hence test the specific contributions of candidate sensory and motor zones. In other studies, investigators will record sensory and motor evoked potentials over the course of learning to determine the temporal order in which individual sensory and cortical motor regions contribute. The goal here is to identify brain areas in which learning-related plasticity occurs first and which among these areas predict subsequent learning.

Trial Health

63
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
38mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress8%
Feb 2026May 2029

First Submitted

Initial submission to the registry

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

July 1, 2024

Last Update Submit

November 20, 2025

Conditions

Keywords

Speech Motor LearningRetention

Outcome Measures

Primary Outcomes (4)

  • Speech motor learning

    Audapter software will be used to alter the first and second formant frequencies of the spoken words and this is played back to subjects through headphones. Subjects will be tested both with unaltered feedback and with abruptly introduced frequency shifts.The change in the first (F1) and second format frequency (F2) values will be assessed using Praat.

    Performance as measured at the end of learning (30 minute session)

  • Retention of learning

    The retention of adaptation to altered auditory feedback (and relearning) will be quantified in terms of F1 and F2 frequency shifts (relative to pre-training baseline). Larger values indicate more complete relearning or retention.

    24 hours after learning (re-test lasts 30 minutes)

  • Change in fMRI resting-state connectivity following speech motor learning

    fMRI resting-state connectivity change following speech motor learning. Functional connectivity will be measured between each of the following regions: Heschel's gyrus, posterior superior temporal gyrus, primary and second somatosensory cortex, supramarginal gyrus, inferior frontal gyrus, motor and ventral premotor cortex and supplementary motor area.

    baseline and at the end of learning (30 minute session)

  • fMRI resting-state connectivity measures of motor memory retention

    fMRI resting-state connectivity measures of motor memory retention. Functional connectivity will be measured between each of the following regions: Heschel's gyrus, posterior superior temporal gyrus, primary and second somatosensory cortex, supramarginal gyrus, inferior frontal gyrus, motor and ventral premotor cortex and supplementary motor area.

    24 hours after learning (re-test lasts 30 minutes)

Study Arms (2)

Altered auditory feedback + fMRI

EXPERIMENTAL

Participants will perform learning tasks then undergo fMRI. This procedure will be repeated on day 2. Functional connectivity patterns between regions that predict learning will be assessed. Participants then leave the laboratory and return 24 hours later to assess retention of learning.

Device: fMRIBehavioral: Adaptation

Control Condition

EXPERIMENTAL

Participants in a control condition who will undergo the same procedures, without altered feedback

Device: fMRIBehavioral: Adaptation

Interventions

fMRIDEVICE

To assess functional connectivity patterns between regions that predict learning.

Altered auditory feedback + fMRIControl Condition
AdaptationBEHAVIORAL

Auditory adaptation in speech

Altered auditory feedback + fMRI

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fluent English speakers
  • Right-handed
  • Normal hearing
  • No speech disorder or reading disability

You may not qualify if:

  • Cardiac pacemaker
  • Aneurysm clip
  • Heart or Vascular clip
  • Prosthetic valve
  • Metal implants
  • Metal in brain, skull, or spinal cord
  • Implanted neurostimulator
  • Medication infusion device
  • Cochlear implant or tinnitus (ringing in ears)
  • Personal and/or family history of epilepsy or other neurological disorders or history of head concussion
  • Psychoactive medications
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Speech

Interventions

Magnetic Resonance ImagingAcclimatization

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAdaptation, PhysiologicalPhysiological PhenomenaAdaptation, BiologicalBiological Phenomena

Study Officials

  • David Ostry

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Healthy right-handed adults with normal hearing will be recruited in equal number from both sexes. All participants will be fluent English speakers.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

February 1, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

May 31, 2029

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations