Speech Motor Learning and Retention (Master Protocol)

Speech Clinical Trial

Official title:

Sensorimotor Basis of Speech Motor Learning and Retention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06467292
• Other study ID #: 2000037622
• Secondary ID: 1R01DC022097-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2027

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: David Ostry
• Phone: 2038656163
• Email: david.ostry[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Speech

Intervention

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

Device:
• Single pulse Transcranial magnetic stimulation (TMS)
TMS will be delivered 10 times in each motor evoked potentials (MEP) recording block.
• fMRI
To assess functional connectivity patterns between regions that predict learning.

Locations

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)