Speech Motor Learning and Retention (Master Protocol)

Sensorimotor Basis of Speech Motor Learning and Retention

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.

Study Overview

• Status: Recruiting
• Conditions: Speech
• Intervention / Treatment: Device: continuous theta-burst stimulation (cTBS); Behavioral: Adaptation; Device: Single pulse Transcranial magnetic stimulation (TMS); Device: fMRI

Detailed Description

Aim 1 involves tests of speech motor memory retention following disruption of left hemisphere brain activity in either auditory, somatosensory or motor cortex or to a control site (hand area motor cortex right hemisphere). Continuous theta-burst stimulation (cTBS) is delivered following adaptation to altered auditory feedback to assess its effects on the retention of new learning.

Aim 2 assesses the temporal order in which plasticity occurs in cortical motor and sensory brain areas during speech motor learning.

In Aim 3, resting-state fMRI will be interleaved with speech motor adaptation. For information specific to each aim, please refer to the below corresponding, separate, clinicaltrials.gov records: unique IDs: 2000037622_a for Aim 1, 2000037622_b for Aim 2 and 2000037622_c for Aim 3.

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Stern; Phone Number: 2038656163; Email: michael.stern@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale Child Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Speech Motor Learning and Retention Aim 1; Aim 1: Participants will perform learning tasks while receiving altered/unaltered auditory feedback with cTBS applied to the appropriate area of the brain following learning. Retention of learning is assessed 24 hours later.	Device: continuous theta-burst stimulation (cTBS); cTBS stimulation will be applied to different areas of the brain following learning. Stimulation will take place following learning in order to block motor memory retention.; Behavioral: Adaptation; Auditory adaptation in speech
Experimental: Speech Motor Learning and Retention Aim 2; Aim 2: Participants will perform learning tasks combined with shifted auditory feedback. Motor cortical excitability will be measured using single-pulse TMS to elicit motor evoked potentials.	Behavioral: Adaptation; Auditory adaptation in speech; Device: Single pulse Transcranial magnetic stimulation (TMS); TMS will be delivered 10 times in each motor evoked potentials (MEP) recording block.
Experimental: Speech Motor Learning and Retention Aim 3; Aim 3: Participants will have fMRI with behavioral measures of speech motor learning.	Behavioral: Adaptation; Auditory adaptation in speech; Device: fMRI; To assess functional connectivity patterns between regions that predict learning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: David Ostry, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Retention; Speech Motor Learning
• Additional Relevant MeSH Terms: Behavior; Communication; Verbal Behavior; Speech; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Physiological Phenomena; Tomography; Diagnostic Imaging; Biological Phenomena; Magnetic Field Therapy; Adaptation, Physiological; Adaptation, Biological; Magnetic Resonance Imaging; Transcranial Magnetic Stimulation; Acclimatization
• Other Study ID Numbers: 2000037622; 1R01DC022097-01A1 (U.S. NIH Grant/Contract: NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No