- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04497428
Sensory Basis of Speech Motor Learning
March 21, 2024 updated by: Yale University
Brain Structures in Speech Motor Memory Consolidation
These studies test the hypothesis that sensory areas of the brain participate in the consolidation of speech motor memory by using transcranial magnetic stimulation to suppress activity in somatosensory and auditory cortex following adaptation in order to block retention of learning.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Subjects will train using either altered somatosensory feedback or altered auditory feedback (different groups of subjects).
Immediately following adaptation, continuous theta burst magnetic stimulation (cTBS) will be applied to either auditory or somatosensory or motor cortex with the goal of blocking consolidation of motor memory.
The logic of applying cTBS to both sensory areas is to test the hypothesis that both areas are involved in motor memory consolidation.
Subjects leave the laboratory following cTBS and return 24 hours later to assess retention of learning.
Learning is assessed as percentage change in speech sounds or movements relative to baseline.
Retention is measured on a 0 to 100 scale relative to the end of learning.
Study Type
Interventional
Enrollment (Estimated)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: David Ostry
- Phone Number: 2038656163
- Email: david.ostry@yale.edu
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3A1G1
- Recruiting
- McGill University
-
Contact:
- Vincent Gracco
- Email: vincent.gracco@mcgill.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- right handed adults
- no known physical or neurological abnormalities
Exclusion Criteria:
- patients with:
- cardiac pacemaker
- surgical clips or values on the heart
- implants
- metal or metallic fragments in any part of the body
- pregnancy
- claustrophobia
- a personal or family history of epilepsy
- currently taking antipsychotic drugs
- currently taking antidepressant drugs
- currently taking antianxiety drugs
- history of concussion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Adaptation to Altered Sensory Feedback + cTBS to S1
|
Sensorimotor adaptation in speech
continuous theta-burst stimulation
|
Experimental: Adaptation to Altered Sensory Feedback + cTBS to A1
|
Sensorimotor adaptation in speech
continuous theta-burst stimulation
|
Experimental: Adaptation to Altered Sensory Feedback + cTBS to M1
|
Sensorimotor adaptation in speech
continuous theta-burst stimulation
|
Experimental: Adaptation to Altered Sensory Feedback + Sham cTBS
|
Sensorimotor adaptation in speech
continuous theta-burst stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor Learning
Time Frame: Performance as measured at the end of learning (30 minute session)
|
Learning is assessed as percentage change in speech sounds (speech formant frequencies) or movements (movement curvature) relative to baseline.
|
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)
|
Retention is measured on a 0 to 100 scale relative to the end of learning.
|
24 hours after learning (re-test lasts 30 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Ostry, Haskins Laboratories
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Estimated)
July 31, 2025
Study Completion (Estimated)
July 31, 2025
Study Registration Dates
First Submitted
July 30, 2020
First Submitted That Met QC Criteria
July 30, 2020
First Posted (Actual)
August 4, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2000025475
- R01DC017439 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Consolidation
-
Yale UniversityMcGill University; National Institute on Deafness and Other Communication Disorders...RecruitingConsolidation | SpeechCanada
-
Yale UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)Recruiting
-
Northumbria UniversityBASFCompletedMemory ConsolidationUnited Kingdom
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)RecruitingMemory ConsolidationUnited States
-
Northwestern UniversityRecruitingSleep | ConsolidationUnited States
-
Northwestern UniversityCompletedSleep | ConsolidationUnited States
-
Northwestern UniversityCompletedSleep | ConsolidationUnited States
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)RecruitingSleep | Learning | Consolidation | HumansUnited States
-
Maastricht University Medical CenterCompletedDopamine Activity | Episodic Memory Consolidation | Response PreparationNetherlands
-
Philips Clinical & Medical Affairs GlobalCompletedPleural Effusion | Lung ConsolidationUnited States
Clinical Trials on Adaptation
-
Dartmouth-Hitchcock Medical CenterMichael J. Fox Foundation for Parkinson's ResearchCompleted
-
University of Southern DenmarkCompletedSchizophreniaDenmark
-
Massachusetts Eye and Ear InfirmaryOregon Health and Science University; National Institute on Deafness and Other... and other collaboratorsEnrolling by invitationMigraine | Dizziness | Motion Sickness | Vestibular Migraine | Vestibular Schwannoma | Vestibular DisorderUnited States
-
Université Catholique de LouvainCompletedCerebral PalsyBelgium
-
The University of Texas Health Science Center at...National Institute of Mental Health (NIMH)Completed
-
University Hospital, GrenobleRecruitingCoronary Microvascular DiseaseFrance
-
Sun Yat-sen UniversityUnknownEsophageal CancerChina
-
Hospices Civils de LyonInstitut National de la Santé Et de la Recherche Médicale, France; Centre National... and other collaboratorsRecruitingChronic Right Supratensorial Stroke PatientsFrance
-
The University of Texas Health Science Center at...National Institute of Mental Health (NIMH)CompletedSchizophrenia | Bipolar Disorder | Depressive Disorder, Major | Schizo Affective DisorderUnited States
-
IRCCS Centro Neurolesi "Bonino-Pulejo"Not yet recruitingParkinson Disease | Visuospatial/Perceptual Abilities | Alexithymia