- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04818268
Sensory Memory in Speech Motor Learning
March 21, 2024 updated by: Yale University
Role of Sensory Working Memory in Speech Motor Learning Aim 2
The proposed studies focus on memory for speech movements and sounds and its relation to learning.
Continuous theta-burst transcranial magnetic stimulation (cTBS) will be used to suppress activity in a region of pre-frontal cortex associated with somatic and auditory working memory (Brodmann area 46v) to test its involvement in learning.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will assess the relationship between sensory working memory and speech motor adaptation using a between subjects design.
Participants will be assigned to one of two groups.
Each group will undergo both auditory and somatosensory working memory tests.
This will be followed by adaptation to altered auditory feedback.
Using a different group of subjects, cTBS will be used to disrupt neural activity in Brodmann area 46v in ventrolateral prefrontal cortex to test its involvement in adaptation.
One set of tests will focus on the effects of cTBS on both auditory and somatosensory working memory.
A second set of tests will focus on the effects of cTBS on speech motor adaptation to altered auditory feedback.
Both working memory and adaptation are assessed on 0 to 100 scales.
Study Type
Interventional
Enrollment (Estimated)
120
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 Auditory Feedback
|
Sensorimotor adaptation in speech
|
Experimental: Auditory Sensory Memory
|
Sensorimotor adaptation in speech
|
Experimental: Somatosensory Sensory Memory
|
Sensorimotor adaptation in speech
|
Experimental: Adaptation to Altered Auditory Feedback + cTBS to 46v
|
Sensorimotor adaptation in speech
continuous theta-burst stimulation
|
Experimental: Sensory Memory + cTBS to 46v
|
Sensorimotor adaptation in speech
continuous theta-burst stimulation
|
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 (single day experiment)
|
Learning is assessed on a 0 to 100 scale as change in speech sounds (speech formant frequencies).
A score of 100 corresponds to complete adaptation.
|
Performance as measured at the end of learning (single day experiment)
|
Sensory Memory
Time Frame: Single day experiment
|
Sensory Memory is measured on a 0 to 100 scale.
A score of 100 corresponds to perfect memory.
|
Single day experiment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
March 19, 2021
First Submitted That Met QC Criteria
March 23, 2021
First Posted (Actual)
March 26, 2021
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_a
- 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.
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