Speech Motor Learning and Retention (Master Protocol)

Not Applicable

Recruiting

• Conditions: Speech
• Interventions: Behavioral: Adaptation; Device: continuous theta-burst stimulation (cTBS); Device: Single pulse Transcranial magnetic stimulation (TMS); Device: fMRI

• Registration Number: NCT06467292
• Lead Sponsor: Yale University

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.

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 Timeline

• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-21
• Study Start: 2024-10-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2028-11-30
• Study Completion: 2029-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Speech Motor Learning and Retention Aim 3	Adaptation	Aim 3: Participants will have fMRI with behavioral measures of speech motor learning.
Speech Motor Learning and Retention Aim 2	Adaptation	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.
Speech Motor Learning and Retention Aim 1	continuous theta-burst stimulation (cTBS)	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.
Speech Motor Learning and Retention Aim 1	Adaptation	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.
Speech Motor Learning and Retention Aim 2	Single pulse Transcranial magnetic stimulation (TMS)	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.
Speech Motor Learning and Retention Aim 3	fMRI	Aim 3: Participants will have fMRI with behavioral measures of speech motor learning.

Primary Outcome Measures

Name	Time	Method
Speech motor learning	Performance as measured at the end of learning (30 minute session)	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.
Retention of learning	24 hours after learning (re-test lasts 30 minutes)	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.

Trial Locations

Locations (1)

Yale Child Study Center; 🇺🇸 New Haven, Connecticut, United States