xml: <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/NCT05996497</url>
    </required_header>
    <id_info>
      <org_study_id>2022-063</org_study_id>
      <secondary_id>2022-A01132-41</secondary_id>
      <nct_id>NCT05996497</nct_id>
    </id_info>
    <brief_title>Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years</brief_title>
    <acronym>RnDys</acronym>
    <official_title>Evaluation of Speech Rhythm Training in Dyslexic Readers Aged 7 to 9 Years</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut Pasteur</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut de l'Audition</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Institut Pasteur</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>
        Studies of dyslexia have shown altered oscillatory activity in the low gamma band (~25-35 Hz)&#xD;
        in the left auditory cortex. Neural oscillations around 30 Hz constitute the basic sampling&#xD;
        rate of speech, from which the ability to form specific phonemic categories on which reading&#xD;
        learning is based is derived. An alteration of the oscillatory activity at 30 Hz could&#xD;
        therefore influence the ability of children to learn to read, and explain the reading deficit&#xD;
        observed in children with a specific written language disorder. The objective of our study is&#xD;
        to determine whether intensive rhythmic auditory stimulation applied during 30 sessions of 15&#xD;
        minutes spread over 6 weeks (5 sessions per week) can correct neural oscillations in the&#xD;
        gamma-low band, allowing an improvement of phonemic categorization abilities, and thus the&#xD;
        reading abilities of dyslexic readers aged 7 to 9 years. The long-term objective of this&#xD;
        study is to test the therapeutic potential of auditory stimulation with speech rhythms for&#xD;
        the treatment of reading disorders.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Longitudinal cross-over study carried out on 4 experimental groups to compare the effect of&#xD;
        two rhythmic auditory trainings (30 Hz and low frequencies) compared to the effect of a&#xD;
        grapho-phonological correspondence training (GraphoGame).&#xD;
  &#xD;
        The study begins with a recruitment and inclusion period after diagnosis of dyslexia. During&#xD;
        this study, 4 assessments are performed and include behavioral measures in the care setting&#xD;
        and electrophysiological measures in the research setting:&#xD;
  &#xD;
          -  at time T1 before any remediation,&#xD;
  &#xD;
          -  at T2 after the first training,&#xD;
  &#xD;
          -  at T3 at most 7 days after the 2nd training session,&#xD;
  &#xD;
          -  at T4 seven weeks after T3.&#xD;
  &#xD;
        After the T1 assessment, participants were randomized into 4 different groups (training 1&#xD;
        then training 2):&#xD;
  &#xD;
        Group 1 : Auditory Rhythmic at 30 Hz then GraphoGame Group 2 : GraphoGame then Rhythmic&#xD;
        Auditory at 30 Hz Group 3 : Auditory Rhythmic at low frequencies then GraphoGame Group 4 :&#xD;
        GraphoGame then Auditory Low Frequency Rhythmic The first training period (total duration 6&#xD;
        weeks) according to the assigned group begins and takes place at the speech therapist's&#xD;
        office and at home.&#xD;
  &#xD;
        After the T2 evaluation, the 2nd training period (total duration 6 weeks) according to the&#xD;
        assigned group begins and takes place at the SLP's office as well as at home.&#xD;
  &#xD;
        The post-training evaluations T3 and T4 take place, respectively, 1 week and 7 weeks after&#xD;
        the last training.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Comparison of reading accuracy by measuring the percentage of correct responses in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).</measure>
      <time_frame>2 years</time_frame>
      <description>Comparison of reading performance is assessed in terms of both accuracy and speed. High percentage of correct responses means that children improve their reading accuracy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Comparison of reading speed by measuring reading time in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).</measure>
      <time_frame>2 years</time_frame>
      <description>Comparison of reading performance is assessed in terms of both accuracy and speed. A short time means that children improve their reading speed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measurement of reading accuracy (percentage of correct responses in the isolated pseudoword reading task) between multiple conditions.</measure>
      <time_frame>2 years</time_frame>
      <description>Reading accuracy compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of reading speed (reading time in the isolated pseudoword reading task) between multiple conditions.</measure>
      <time_frame>2 years</time_frame>
      <description>Reading speed compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Dyslexia</condition>
    <arm_group>
      <arm_group_label>Auditory Rhythmic at 30 Hz then GraphoGame</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Training 1 with Auditory Rhythmic at 30 Hz (6 weeks) then Training 2 with GraphoGame (6 weeks)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>GraphoGame then Rhythmic Auditory at 30 Hz</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at 30 Hz (6 weeks)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Auditory Rhythmic at low frequencies then GraphoGame</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Training 1 with Auditory Rhythmic at low frequencies (6 weeks) then Training 2 with GraphoGame (6 weeks)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>GraphoGame then Auditory Low Frequency Rhythmic</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at Low Frequency Rhythmic (6 weeks)</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>behavioral measures</intervention_name>
      <description>behavioral measures</description>
      <arm_group_label>Auditory Rhythmic at 30 Hz then GraphoGame</arm_group_label>
      <arm_group_label>Auditory Rhythmic at low frequencies then GraphoGame</arm_group_label>
      <arm_group_label>GraphoGame then Auditory Low Frequency Rhythmic</arm_group_label>
      <arm_group_label>GraphoGame then Rhythmic Auditory at 30 Hz</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Electrophysiological measures</intervention_name>
      <description>Electrophysiological measures</description>
      <arm_group_label>Auditory Rhythmic at 30 Hz then GraphoGame</arm_group_label>
      <arm_group_label>Auditory Rhythmic at low frequencies then GraphoGame</arm_group_label>
      <arm_group_label>GraphoGame then Auditory Low Frequency Rhythmic</arm_group_label>
      <arm_group_label>GraphoGame then Rhythmic Auditory at 30 Hz</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Training 1</intervention_name>
      <description>Training 1</description>
      <arm_group_label>Auditory Rhythmic at 30 Hz then GraphoGame</arm_group_label>
      <arm_group_label>Auditory Rhythmic at low frequencies then GraphoGame</arm_group_label>
      <arm_group_label>GraphoGame then Auditory Low Frequency Rhythmic</arm_group_label>
      <arm_group_label>GraphoGame then Rhythmic Auditory at 30 Hz</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Training 2</intervention_name>
      <description>Training 2</description>
      <arm_group_label>Auditory Rhythmic at 30 Hz then GraphoGame</arm_group_label>
      <arm_group_label>Auditory Rhythmic at low frequencies then GraphoGame</arm_group_label>
      <arm_group_label>GraphoGame then Auditory Low Frequency Rhythmic</arm_group_label>
      <arm_group_label>GraphoGame then Rhythmic Auditory at 30 Hz</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  between 7 and 9 years old&#xD;
  &#xD;
            -  in regular schooling&#xD;
  &#xD;
            -  have a diagnosis of dyslexia&#xD;
  &#xD;
            -  have a non-verbal intelligence assessment within the norm. Inclusion assessments must&#xD;
               show a major reading disability without associated cognitive deficits.&#xD;
  &#xD;
            -  be equipped with a PC at home&#xD;
  &#xD;
            -  have given their assent and whose parents/legal guardians have given their oral&#xD;
               consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  have any other diagnosis of language impairment&#xD;
  &#xD;
            -  have a neurological disorder (visual, auditory, executive)&#xD;
  &#xD;
            -  have an associated psychiatric disorder&#xD;
  &#xD;
            -  have a developmental delay.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>9 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Diane Lazard, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institut Pasteur</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Anne-Lise Giraud, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Institut Pasteur</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sophie Bouton, PhD</last_name>
      <email>sophie.bouton@pasteur.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anne-Lise Giraud, PhD</last_name>
      <phone>+33176535054</phone>
      <email>anne-lise.giraud-mamessier@pasteur.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Institut de l'Audition</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Diane Lazard, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyslexia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996497
  org study id: 2022-063
  secondary id: 2022-A01132-41
  nct id: NCT05996497
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Studies of dyslexia have shown altered oscillatory activity in the low gamma band (~25-35 Hz)
        in the left auditory cortex. Neural oscillations around 30 Hz constitute the basic sampling
        rate of speech, from which the ability to form specific phonemic categories on which reading
        learning is based is derived. An alteration of the oscillatory activity at 30 Hz could
        therefore influence the ability of children to learn to read, and explain the reading deficit
        observed in children with a specific written language disorder. The objective of our study is
        to determine whether intensive rhythmic auditory stimulation applied during 30 sessions of 15
        minutes spread over 6 weeks (5 sessions per week) can correct neural oscillations in the
        gamma-low band, allowing an improvement of phonemic categorization abilities, and thus the
        reading abilities of dyslexic readers aged 7 to 9 years. The long-term objective of this
        study is to test the therapeutic potential of auditory stimulation with speech rhythms for
        the treatment of reading disorders.
  Longitudinal cross-over study carried out on 4 experimental groups to compare the effect of
        two rhythmic auditory trainings (30 Hz and low frequencies) compared to the effect of a
        grapho-phonological correspondence training (GraphoGame).
  
        The study begins with a recruitment and inclusion period after diagnosis of dyslexia. During
        this study, 4 assessments are performed and include behavioral measures in the care setting
        and electrophysiological measures in the research setting:
  
          -  at time T1 before any remediation,
  
          -  at T2 after the first training,
  
          -  at T3 at most 7 days after the 2nd training session,
  
          -  at T4 seven weeks after T3.
  
        After the T1 assessment, participants were randomized into 4 different groups (training 1
        then training 2):
  
        Group 1 : Auditory Rhythmic at 30 Hz then GraphoGame Group 2 : GraphoGame then Rhythmic
        Auditory at 30 Hz Group 3 : Auditory Rhythmic at low frequencies then GraphoGame Group 4 :
        GraphoGame then Auditory Low Frequency Rhythmic The first training period (total duration 6
        weeks) according to the assigned group begins and takes place at the speech therapist's
        office and at home.
  
        After the T2 evaluation, the 2nd training period (total duration 6 weeks) according to the
        assigned group begins and takes place at the SLP's office as well as at home.
  
        The post-training evaluations T3 and T4 take place, respectively, 1 week and 7 weeks after
        the last training.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Comparison of reading accuracy by measuring the percentage of correct responses in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).
  time frame: 2 years
  description: Comparison of reading performance is assessed in terms of both accuracy and speed. High percentage of correct responses means that children improve their reading accuracy.
  measure: Comparison of reading speed by measuring reading time in the isolated pseudoword reading task between rythmic auditory training condition vs. grapho-phonological mapping training (GraphoGame).
  time frame: 2 years
  description: Comparison of reading performance is assessed in terms of both accuracy and speed. A short time means that children improve their reading speed.
  measure: Measurement of reading accuracy (percentage of correct responses in the isolated pseudoword reading task) between multiple conditions.
  time frame: 2 years
  description: Reading accuracy compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz
  measure: Measurement of reading speed (reading time in the isolated pseudoword reading task) between multiple conditions.
  time frame: 2 years
  description: Reading speed compared between rhythmic auditory training then grapho-phonological mapping training vs. grapho-phonological mapping training then rhythmic auditory training and rhythmic auditory training at 30 Hz vs. rhythmic auditory training at 3.5 Hz
  arm group label: Auditory Rhythmic at 30 Hz then GraphoGame
  arm group type: Other
  description: Training 1 with Auditory Rhythmic at 30 Hz (6 weeks) then Training 2 with GraphoGame (6 weeks)
  arm group label: GraphoGame then Rhythmic Auditory at 30 Hz
  arm group type: Other
  description: Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at 30 Hz (6 weeks)
  arm group label: Auditory Rhythmic at low frequencies then GraphoGame
  arm group type: Other
  description: Training 1 with Auditory Rhythmic at low frequencies (6 weeks) then Training 2 with GraphoGame (6 weeks)
  arm group label: GraphoGame then Auditory Low Frequency Rhythmic
  arm group type: Other
  description: Training 1 with GraphoGame (6 weeks) then Training 2 with Auditory Rhythmic at Low Frequency Rhythmic (6 weeks)
  intervention type: Behavioral
  intervention name: behavioral measures
  description: behavioral measures
  arm group label: Auditory Rhythmic at 30 Hz then GraphoGame
  arm group label: Auditory Rhythmic at low frequencies then GraphoGame
  arm group label: GraphoGame then Auditory Low Frequency Rhythmic
  arm group label: GraphoGame then Rhythmic Auditory at 30 Hz
  intervention type: Other
  intervention name: Electrophysiological measures
  description: Electrophysiological measures
  arm group label: Auditory Rhythmic at 30 Hz then GraphoGame
  arm group label: Auditory Rhythmic at low frequencies then GraphoGame
  arm group label: GraphoGame then Auditory Low Frequency Rhythmic
  arm group label: GraphoGame then Rhythmic Auditory at 30 Hz
  intervention type: Other
  intervention name: Training 1
  description: Training 1
  arm group label: Auditory Rhythmic at 30 Hz then GraphoGame
  arm group label: Auditory Rhythmic at low frequencies then GraphoGame
  arm group label: GraphoGame then Auditory Low Frequency Rhythmic
  arm group label: GraphoGame then Rhythmic Auditory at 30 Hz
  intervention type: Other
  intervention name: Training 2
  description: Training 2
  arm group label: Auditory Rhythmic at 30 Hz then GraphoGame
  arm group label: Auditory Rhythmic at low frequencies then GraphoGame
  arm group label: GraphoGame then Auditory Low Frequency Rhythmic
  arm group label: GraphoGame then Rhythmic Auditory at 30 Hz
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 9 Years
  healthy volunteers: No
  last name: Diane Lazard, MD
  role: Principal Investigator
  affiliation: Institut Pasteur
  last name: Anne-Lise Giraud, PhD
  role: Study Director
  affiliation: Institut Pasteur
  last name: Sophie Bouton, PhD
  email: sophie.bouton@pasteur.fr
  last name: Anne-Lise Giraud, PhD
  phone: +33176535054
  email: anne-lise.giraud-mamessier@pasteur.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Dyslexia