- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06467305
Speech Motor Learning and Retention (Aim 1)
Sensorimotor Basis of Speech Motor Learning and Retention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The focus of this registration is Aim 1. The work in Specific 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. In the adaptation task, participants read Harvard Sentences aloud, which are presented on a computer monitor. Vocal output is altered in real-time and played back to participants through headphones. Tests of retention are conducted 24 hours later.
The Speech Motor Learning and Retention Master Protocol has uniqueID 2000037622.
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: Altered auditory feedback + cTBS to auditory cortex
Participants will perform learning tasks while receiving altered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere auditory cortex following learning.
Participants then leave the laboratory and return 24 hours later to assess retention of learning.
|
Auditory adaptation in speech
Non-invasive brain stimulation, evoked potentials and fMRI will be used to identify brain regions involved in speech motor learning and retention.
|
|
Experimental: Altered auditory feedback + cTBS to somatosensory cortex
Participants will perform learning tasks while receiving altered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere somatosensory cortex following learning.
Participants then leave the laboratory and return 24 hours later to assess retention of learning.
|
Auditory adaptation in speech
Non-invasive brain stimulation, evoked potentials and fMRI will be used to identify brain regions involved in speech motor learning and retention.
|
|
Experimental: Altered auditory feedback + cTBS to motor cortex
Participants will perform learning tasks while receiving altered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere motor cortex following learning.
Participants then leave the laboratory and return 24 hours later to assess retention of learning.
|
Auditory adaptation in speech
Non-invasive brain stimulation, evoked potentials and fMRI will be used to identify brain regions involved in speech motor learning and retention.
|
|
Experimental: Altered auditory feedback + cTBS to motor cortex control zone
Participants in a control condition will undergo the same procedures using cTBS to a motor cortex control zone in the right hemisphere (associated with the hand muscle first dorsal interosseous).
cTBS will be applied following learning and subjects will return 24 hours later to test for retention.
This control condition is included as a test for non-specific effects of cTBS stimulation.
|
Auditory adaptation in speech
Non-invasive brain stimulation, evoked potentials and fMRI will be used to identify brain regions involved in speech motor learning and retention.
|
|
Experimental: Unaltered auditory feedback + cTBS to auditory cortex
Participants will perform learning tasks while receiving unaltered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere auditory cortex following learning.
Participants then leave the laboratory and return 24 hours later to assess retention of learning.
If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.
|
Auditory adaptation in speech
Non-invasive brain stimulation, evoked potentials and fMRI will be used to identify brain regions involved in speech motor learning and retention.
|
|
Experimental: Unaltered auditory feedback + cTBS to somatosensory cortex
Participants will perform learning tasks while receiving unaltered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere somatosensory cortex following learning.
Participants then leave the laboratory and return 24 hours later to assess retention of learning.
If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.
|
Auditory adaptation in speech
Non-invasive brain stimulation, evoked potentials and fMRI will be used to identify brain regions involved in speech motor learning and retention.
|
|
Experimental: Unaltered auditory feedback + cTBS to motor cortex
Participants will perform learning tasks while receiving unaltered auditory feedback.This procedure will be repeated on day 2. cTBS will be applied to the left hemisphere motor cortex following learning.
Participants then leave the laboratory and return 24 hours later to assess retention of learning.
If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.
|
Auditory adaptation in speech
Non-invasive brain stimulation, evoked potentials and fMRI will be used to identify brain regions involved in speech motor learning and retention.
|
|
Experimental: Unaltered auditory feedback + cTBS to motor cortex control zone
Participants in a control condition will undergo the same procedures using cTBS to a motor cortex control zone in the right hemisphere (associated with the hand muscle first dorsal interosseous).
cTBS will be applied following learning and subjects will return 24 hours later to test for retention.
This control condition is included as a test for non-specific effects of cTBS stimulation.
If the effects of cTBS are specific to learning, no effect should be observed in these control conditions.
|
Auditory adaptation in speech
Non-invasive brain stimulation, evoked potentials and fMRI will be used to identify brain regions involved in speech motor learning and retention.
|
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)
|
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_a
- 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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