<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04497428</url>
  </required_header>
  <id_info>
    <org_study_id>2000025475</org_study_id>
    <secondary_id>R01DC017439</secondary_id>
    <nct_id>NCT04497428</nct_id>
  </id_info>
  <brief_title>Sensory Basis of Speech Motor Learning</brief_title>
  <official_title>Brain Structures in Speech Motor Memory Consolidation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      These studies test the hypothesis that sensory areas of the brain participate in the&#xD;
      consolidation of speech motor memory by using transcranial magnetic stimulation to suppress&#xD;
      activity in somatosensory and auditory cortex following adaptation in order to block&#xD;
      retention of learning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will train using either altered somatosensory feedback or altered auditory feedback&#xD;
      (different groups of subjects). Immediately following adaptation, continuous theta burst&#xD;
      magnetic stimulation (cTBS) will be applied to either auditory or somatosensory or motor&#xD;
      cortex with the goal of blocking consolidation of motor memory. The logic of applying cTBS to&#xD;
      both sensory areas is to test the hypothesis that both areas are involved in motor memory&#xD;
      consolidation. Subjects leave the laboratory following cTBS and return 24 hours later to&#xD;
      assess retention of learning. Learning is assessed as percentage change in speech sounds or&#xD;
      movements relative to baseline. Retention is measured on a 0 to 100 scale relative to the end&#xD;
      of learning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motor Learning</measure>
    <time_frame>Performance as measured at the end of learning (30 minute session)</time_frame>
    <description>Learning is assessed as percentage change in speech sounds (speech formant frequencies) or movements (movement curvature) relative to baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention of Learning</measure>
    <time_frame>24 hours after learning (re-test lasts 30 minutes)</time_frame>
    <description>Retention is measured on a 0 to 100 scale relative to the end of learning.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Speech</condition>
  <condition>Consolidation</condition>
  <arm_group>
    <arm_group_label>Adaptation to Altered Sensory Feedback + cTBS to S1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adaptation to Altered Sensory Feedback + cTBS to S1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adaptation to Altered Sensory Feedback + cTBS to A1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adaptation to Altered Sensory Feedback + cTBS to A1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adaptation to Altered Sensory Feedback + cTBS to M1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adaptation to Altered Sensory Feedback + cTBS to M1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adaptation to Altered Sensory Feedback + Sham cTBS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adaptation to Altered Sensory Feedback + Sham cTBS</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Adaptation</intervention_name>
    <description>Sensorimotor adaptation in speech</description>
    <arm_group_label>Adaptation to Altered Sensory Feedback + Sham cTBS</arm_group_label>
    <arm_group_label>Adaptation to Altered Sensory Feedback + cTBS to A1</arm_group_label>
    <arm_group_label>Adaptation to Altered Sensory Feedback + cTBS to M1</arm_group_label>
    <arm_group_label>Adaptation to Altered Sensory Feedback + cTBS to S1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cTBS</intervention_name>
    <description>continuous theta-burst stimulation</description>
    <arm_group_label>Adaptation to Altered Sensory Feedback + Sham cTBS</arm_group_label>
    <arm_group_label>Adaptation to Altered Sensory Feedback + cTBS to A1</arm_group_label>
    <arm_group_label>Adaptation to Altered Sensory Feedback + cTBS to M1</arm_group_label>
    <arm_group_label>Adaptation to Altered Sensory Feedback + cTBS to S1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  right handed adults&#xD;
&#xD;
          -  no known physical or neurological abnormalities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with:&#xD;
&#xD;
          -  cardiac pacemaker&#xD;
&#xD;
          -  surgical clips or values on the heart&#xD;
&#xD;
          -  implants&#xD;
&#xD;
          -  metal or metallic fragments in any part of the body&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  a personal or family history of epilepsy&#xD;
&#xD;
          -  currently taking antipsychotic drugs&#xD;
&#xD;
          -  currently taking antidepressant drugs&#xD;
&#xD;
          -  currently taking antianxiety drugs&#xD;
&#xD;
          -  history of concussion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Ostry</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haskins Laboratories</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Ostry</last_name>
    <phone>2038656163</phone>
    <email>david.ostry@yale.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>McGill Univeristy</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3A1G1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent Gracco</last_name>
      <email>vincent.gracco@mcgill.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>February 22, 2023</last_update_submitted>
  <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT04497428/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04497428
org study id: 2000025475
secondary id: R01DC017439
nct id: NCT04497428
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Motor Learning
time frame: Performance as measured at the end of learning (30 minute session)
description: Learning is assessed as percentage change in speech sounds (speech formant frequencies) or movements (movement curvature) relative to baseline.
measure: Retention of Learning
time frame: 24 hours after learning (re-test lasts 30 minutes)
description: Retention is measured on a 0 to 100 scale relative to the end of learning.
arm group label: Adaptation to Altered Sensory Feedback + cTBS to S1
arm group type: Experimental
description: Adaptation to Altered Sensory Feedback + cTBS to S1
arm group label: Adaptation to Altered Sensory Feedback + cTBS to A1
arm group type: Experimental
description: Adaptation to Altered Sensory Feedback + cTBS to A1
arm group label: Adaptation to Altered Sensory Feedback + cTBS to M1
arm group type: Experimental
description: Adaptation to Altered Sensory Feedback + cTBS to M1
arm group label: Adaptation to Altered Sensory Feedback + Sham cTBS
arm group type: Experimental
description: Adaptation to Altered Sensory Feedback + Sham cTBS
intervention type: Behavioral
intervention name: Adaptation
description: Sensorimotor adaptation in speech
arm group label: Adaptation to Altered Sensory Feedback + Sham cTBS
arm group label: Adaptation to Altered Sensory Feedback + cTBS to A1
arm group label: Adaptation to Altered Sensory Feedback + cTBS to M1
arm group label: Adaptation to Altered Sensory Feedback + cTBS to S1
intervention type: Other
intervention name: cTBS
description: continuous theta-burst stimulation
arm group label: Adaptation to Altered Sensory Feedback + Sham cTBS
arm group label: Adaptation to Altered Sensory Feedback + cTBS to A1
arm group label: Adaptation to Altered Sensory Feedback + cTBS to M1
arm group label: Adaptation to Altered Sensory Feedback + cTBS to S1
criteria: 
gender: All
minimum age: 21 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Ostry
role: Principal Investigator
affiliation: Haskins Laboratories
last name: David Ostry
phone: 2038656163
email: david.ostry@yale.edu
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
sharing ipd: No
provided document: 