NCT06467305

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

77
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
38mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress34%
Oct 2024May 2029

First Submitted

Initial submission to the registry

June 13, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
4.2 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

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

June 13, 2024

Last Update Submit

February 17, 2026

Conditions

Keywords

Speech Motor LearningRetention

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (8)

Altered auditory feedback + cTBS to auditory cortex

EXPERIMENTAL

Participants will perform learning tasks while receiving altered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere auditory cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning.

Device: continuous theta-burst stimulation (cTBS)Behavioral: Adaptation

Altered auditory feedback + cTBS to somatosensory cortex

EXPERIMENTAL

Participants will perform learning tasks while receiving altered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere somatosensory cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning.

Device: continuous theta-burst stimulation (cTBS)Behavioral: Adaptation

Altered auditory feedback + cTBS to motor cortex

EXPERIMENTAL

Participants will perform learning tasks while receiving altered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere motor cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning.

Device: continuous theta-burst stimulation (cTBS)Behavioral: Adaptation

Altered auditory feedback + cTBS to motor cortex control zone

EXPERIMENTAL

Participants in a control condition will undergo the same procedures using cTBS to a motor cortex control zone in the right hemisphere (associated with the hand muscle first dorsal interosseous). cTBS will be applied following learning and subjects will return 24 hours later to test for retention. This control condition is included as a test for non-specific effects of cTBS stimulation.

Device: continuous theta-burst stimulation (cTBS)Behavioral: Adaptation

Unaltered auditory feedback + cTBS to auditory cortex

EXPERIMENTAL

Participants will perform learning tasks while receiving unaltered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere auditory cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning. If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.

Device: continuous theta-burst stimulation (cTBS)Behavioral: Adaptation

Unaltered auditory feedback + cTBS to somatosensory cortex

EXPERIMENTAL

Participants will perform learning tasks while receiving unaltered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere somatosensory cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning. If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.

Device: continuous theta-burst stimulation (cTBS)Behavioral: Adaptation

Unaltered auditory feedback + cTBS to motor cortex

EXPERIMENTAL

Participants will perform learning tasks while receiving unaltered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere motor cortex following learning. Participants then leave the laboratory and return 24 hours later to assess retention of learning. If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.

Device: continuous theta-burst stimulation (cTBS)Behavioral: Adaptation

Unaltered auditory feedback + cTBS to motor cortex control zone

EXPERIMENTAL

Participants in a control condition will undergo the same procedures using cTBS to a motor cortex control zone in the right hemisphere (associated with the hand muscle first dorsal interosseous). cTBS will be applied following learning and subjects will return 24 hours later to test for retention. This control condition is included as a test for non-specific effects of cTBS stimulation. If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.

Device: continuous theta-burst stimulation (cTBS)Behavioral: Adaptation

Interventions

AdaptationBEHAVIORAL

Auditory adaptation in speech

Altered auditory feedback + cTBS to auditory cortexAltered auditory feedback + cTBS to motor cortexAltered auditory feedback + cTBS to motor cortex control zoneAltered auditory feedback + cTBS to somatosensory cortexUnaltered auditory feedback + cTBS to auditory cortexUnaltered auditory feedback + cTBS to motor cortexUnaltered auditory feedback + cTBS to motor cortex control zoneUnaltered auditory feedback + cTBS to somatosensory cortex

Non-invasive brain stimulation, evoked potentials and fMRI will be used to identify brain regions involved in speech motor learning and retention.

Altered auditory feedback + cTBS to auditory cortexAltered auditory feedback + cTBS to motor cortexAltered auditory feedback + cTBS to motor cortex control zoneAltered auditory feedback + cTBS to somatosensory cortexUnaltered auditory feedback + cTBS to auditory cortexUnaltered auditory feedback + cTBS to motor cortexUnaltered auditory feedback + cTBS to motor cortex control zoneUnaltered auditory feedback + cTBS to somatosensory cortex

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

RECRUITING

MeSH Terms

Conditions

Speech

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Adaptation, 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

June 13, 2024

First Posted

June 21, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

May 31, 2029

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations