- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06491823
Speech Motor Learning and Retention (Aim 2)
Sensorimotor Basis of Speech Motor Learning and Retention
Study Overview
Status
Conditions
Detailed Description
The focus of this registration is Aim 2. Specific Aim 2 assesses the temporal order in which plasticity occurs in cortical motor and sensory brain areas during speech motor learning. Plasticity is assessed using measures of cortical excitability. Specifically, auditory, somatosensory and motor evoked potentials are elicited using single pulse TMS (motor), pure tone bursts (auditory), and mentalis nerve stimulation (somatosensory). Tests of cortical excitability are interleaved with trials involving speech motor adaptation. Cortical excitability is also measured using these same measures 24 hours after learning to assess retention.
The Speech Motor Learning and Retention Master Protocol is NCT06467292.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Ostry
- Phone Number: 2038656163
- Email: david.ostry@yale.edu
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Recruiting
- Yale Child Study Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MEPs (M1) / altered auditory feedback / MEPs + retention tests at 24h
Evoked potentials will be recorded from brain area M1 (motor cortex) in combination with a speech motor learning procedure known as adaptation to altered auditory feedback.
Retention of learning will be tested 24h later along with additional evoked potential recordings.
|
Auditory adaptation in speech
motor evoked potentials will be obtained in each recording block
|
|
Experimental: AEPs (A1) / altered auditory feedback / AEPs + retention tests at 24h
Evoked potentials will be recorded from brain area A1 (auditory cortex) in combination with a speech motor learning procedure known as adaptation to altered auditory feedback.
Retention of learning will be tested 24h later along with additional evoked potential recordings.
|
Auditory adaptation in speech
auditory evoked potentials will be obtained in each recording block
|
|
Experimental: SEPs (S1) / altered auditory feedback / SEPs + retention tests at 24h
Evoked potentials will be recorded from brain area S1 (somatosensory cortex) in combination with a speech motor learning procedure known as adaptation to altered auditory feedback.
Retention of learning will be tested 24h later along with additional evoked potential recordings.
|
Auditory adaptation in speech
Somatosensry evoked potentials will be obtained in each recording block
|
|
Experimental: MEPs (M1) / unaltered auditory feedback / MEPs + retention tests at 24h
Evoked potentials will be recorded from brain area M1 (motor cortex) in combination with unaltered auditory feedback.
Retention of learning will be tested 24h later along with additional evoked potential recordings.
|
motor evoked potentials will be obtained in each recording block
Auditory baseline in speech
|
|
Experimental: AEPs (A1) / unaltered auditory feedback / AEPs + retention tests at 24h
Evoked potentials will be recorded from brain area A1 (auditory cortex) in combination with unaltered auditory feedback.
Retention of learning will be tested 24h later along with additional evoked potential recordings.
|
auditory evoked potentials will be obtained in each recording block
Auditory baseline in speech
|
|
Experimental: SEPs (S1) / unaltered auditory feedback / SEPs + retention tests at 24h
Evoked potentials will be recorded from brain area S1 (somatosensory cortex) in combination with unaltered auditory feedback.
Retention of learning will be tested 24h later along with additional evoked potential recordings.
|
Somatosensry evoked potentials will be obtained in each recording block
Auditory baseline in speech
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech motor learning
Time Frame: 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.
|
Performance as measured at the end of learning (30 minute session)
|
|
Retention of learning
Time Frame: 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.
|
24 hours after learning (re-test lasts 30 minutes)
|
|
Motor evoked potentials (MEPs)
Time Frame: Performance as measured at the end of learning (30 minute session)
|
Motor evoked potentials (MEPs) using single-pulse TMS will be recorded using surface electromyography (EMG) to measure MEP peak-to-peak response
|
Performance as measured at the end of learning (30 minute session)
|
|
Somatosensory evoked potentials (SEPs)
Time Frame: Performance as measured at the end of learning (30 minute session)
|
Electrical stimulation will be used to elicit somatosensory evoked potentials (SEPs).
SEPs will be recorded using electroencephalogram (EEG) to measure the SEP response in the interval 20 to 25 ms following stimulation (N20-P25 response).
|
Performance as measured at the end of learning (30 minute session)
|
|
Auditory evoked potentials (AEPs)
Time Frame: Performance as measured at the end of learning (30 minute session)
|
Acoustical stimulation will be used to elicit auditory evoked potentials (AEPs).
AEPs will be recorded using electroencephalogram (EEG) to measure the AEP response in the interval between the first positive peak and first negative peak following stimulation (P1-N1 response).
|
Performance as measured at the end of learning (30 minute session)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Ostry, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000037622_b
- 1R01DC022097-01A1 (U.S. NIH Grant/Contract: NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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