Speech Motor Learning and Retention (Master Protocol)

Yale University

Status: Enrolling

Conditions: Speech

Treatments: Device: fMRI; Behavioral: Adaptation; Device: Single pulse Transcranial magnetic stimulation (TMS); Device: continuous theta-burst stimulation (cTBS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06467292

2000037622

1R01DC022097-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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330 participants in 3 patient groups

Speech Motor Learning and Retention Aim 1

Experimental group

Description:

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.

Treatment:

Device: continuous theta-burst stimulation (cTBS)

Behavioral: Adaptation

Speech Motor Learning and Retention Aim 2

Experimental group

Description:

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.

Treatment:

Device: Single pulse Transcranial magnetic stimulation (TMS)

Behavioral: Adaptation

Speech Motor Learning and Retention Aim 3

Experimental group

Description:

Aim 3: Participants will have fMRI with behavioral measures of speech motor learning.

Treatment:

Behavioral: Adaptation

Device: fMRI