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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04818268
Other study ID # 2000025475_a
Secondary ID R01DC017439
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date July 31, 2025

Study information

Verified date March 2024
Source Yale University
Contact David Ostry
Phone 2038656163
Email david.ostry@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date July 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Adaptation
Sensorimotor adaptation in speech
Other:
cTBS
continuous theta-burst stimulation

Locations

Country Name City State
Canada McGill University Montréal Quebec

Sponsors (2)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Speech Motor Learning 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)
Primary Sensory Memory Sensory Memory is measured on a 0 to 100 scale. A score of 100 corresponds to perfect memory. Single day experiment
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