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/NCT05972200</url>
    </required_header>
    <id_info>
      <org_study_id>3073_OPBG_2023</org_study_id>
      <nct_id>NCT05972200</nct_id>
    </id_info>
    <brief_title>V5/MT Stimulation on Reading and Reading-related Measures in Developmental Dyslexia</brief_title>
    <official_title>Probing the Efficacy of V5/MT Stimulation on Reading and Reading-related Measures in Children and Adolescents With Developmental Dyslexia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bambino Gesù Hospital and Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bambino Gesù Hospital and Research Institute</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>
        The present study grounds on the absence of evidence-based treatment in individuals with&#xD;
        developmental dyslexia (DD). At this topic, the present study will explore the potential&#xD;
        effect of transcranial direct current stimulation (tDCS) over left hemispheric direct Lateral&#xD;
        Geniculate Nucleus (LGN)-V5/MT pathway, cerebral areas usually disrupted in individuals with&#xD;
        DD.&#xD;
  &#xD;
        The investigators hypothesized that active tDCS over V5/MT will boost reading skills in&#xD;
        children and adolescents with DD. On the contrary, sham (placebo condition) tDCS over V5/MT&#xD;
        or active (control condition) tDCS over V1 will not have significant effect in improving&#xD;
        reading skills. Further, both active and sham tDCS will be safe and well tolerated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Over the last few decades, a huge number of studies has revealed that Developmental Dyslexia&#xD;
        (DD), a brain-based neurodevelopmental disorder characterized by a severe and persistent&#xD;
        impairment in the acquisition of reading skills may depend on multiple neurocognitive&#xD;
        impairments, ranging from language-specific to cognitive-general deficits. Besides the most&#xD;
        influential hypothesis of a phonological core deficit, there is also evidence for&#xD;
        difficulties in low-level visual-temporal information processing, as the magnocellular&#xD;
        deficit theory supports, as well as for visual-spatial attentional deficits,&#xD;
        visual-perceptual impairments, and rapid automatized naming (RAN)-speed deficits.&#xD;
  &#xD;
        Replicated structural/functional neuroimaging studies have demonstrated a DD hypoactivation&#xD;
        relative to typical readers in the left temporo-occipital regions-critical for the automatic&#xD;
        visual processing of word strings or print-and in the left temporo-parietal regions-important&#xD;
        for grapheme-to-phoneme mapping.&#xD;
  &#xD;
        Moreover, findings from animal models and post mortem studies in humans suggest that DD might&#xD;
        also be associated with structural alterations in subcortical sensory pathways, particularly&#xD;
        in visual and auditory thalamic nuclei and in their connections with high-order sensory&#xD;
        cortices (i.e., the left hemispheric direct Lateral Geniculate Nucleus (LGN)-V5/MT pathway&#xD;
        and the left hemispheric direct Medial Geniculate Body (MGB)-mPT pathway). In addition, in&#xD;
        adults with DD, left V5/MT-LGN connectivity strength correlated with RAN abilities - a key&#xD;
        deficit in DD.&#xD;
  &#xD;
        A number of studies have demonstrated the positive effect of transcranial direct current&#xD;
        stimulation (tDCS), a non-invasive brain stimulation used for transiently modifying neural&#xD;
        activity of target areas, on reading and, particularly, in DD.&#xD;
  &#xD;
        However, the few non-invasive brain stimulation studies on improving reading in DD yielded&#xD;
        heterogeneous results and this variability might be partly due to the lack of neurobiological&#xD;
        understanding of the underlying DD mechanism or to the use of traditional tDCS rather than a&#xD;
        more focal technique such as the high-definition tDCS (HD-tDCS).&#xD;
  &#xD;
        Starting from this, the aim of the current study is testing the effectiveness of a&#xD;
        cutting-edge stimulation technique (i.e., HD-tDCS) in a within-subject experiment involving&#xD;
        children and adolescents with DD. Especially, we will work to test i) the specific effect of&#xD;
        HD-tDCS over high-order sensory cortices (i.e., V5/MT vs V1) on reading in children with DD;&#xD;
        ii) the preconditions and neurobiological mechanisms that lead to high treatment outcomes.&#xD;
  &#xD;
        If the stimulation over V5/MT is effective and specifically related to reading improvement,&#xD;
        our results could help to i) understand the contribution and neurobiological mechanism of&#xD;
        V5/MT in reading of children and adolescents with DD; ii) select criteria for potential&#xD;
        responders to non-invasive brain stimulation; iii) develop evidence-based interventions in&#xD;
        DD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2026</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Text reading accuracy (Experimental reading task)</measure>
      <time_frame>during procedure</time_frame>
      <description>Change in text reading accuracy from baseline compared after to Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Text reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.&#xD;
  The time points will be pre- (baseline) vs post-stimulation session.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Text reading speed (Experimental reading task)</measure>
      <time_frame>during procedure</time_frame>
      <description>Change in text reading speed from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Text reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).&#xD;
  The time points will be pre- (baseline) vs post-stimulation session.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Word reading accuracy (Experimental reading task)</measure>
      <time_frame>during procedure</time_frame>
      <description>Change in word reading accuracy from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Word reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.&#xD;
  The time points will be pre- (baseline) vs post-stimulation session.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Word reading speed (Experimental reading task)</measure>
      <time_frame>during procedure</time_frame>
      <description>Change in word reading speed from baseline compared to after Active HD-tDCS over V5/MT sessions than during Active HD-tDCS over V1 and Sham sessions. Word reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).&#xD;
  The time points will be pre- (baseline) vs post-stimulation session.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-word reading accuracy (Experimental reading task)</measure>
      <time_frame>during procedure</time_frame>
      <description>Change in non-word reading accuracy from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Non-word reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.&#xD;
  The time points will be pre- (baseline) vs post-stimulation session.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-word reading speed (Experimental reading task)</measure>
      <time_frame>during procedure</time_frame>
      <description>Change in non-word reading speed from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Non-word reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).&#xD;
  The time points will be pre- (baseline) vs post-stimulation session.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Right visual hemisphere-motion perception (Experimental reading task)</measure>
      <time_frame>during procedure</time_frame>
      <description>Change in right visual hemisphere-motion perception from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Right visual hemisphere-motion perception is considered as the number of correct saccades.&#xD;
  The time points will be pre- (baseline) vs post-stimulation session.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rapid automatized naming letter and number (Experimental reading task)</measure>
      <time_frame>during procedure</time_frame>
      <description>Change in rapid automatized naming letter and number from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Rapid automatized naming letter and number is considered as the total time spent (in seconds) to complete the task.&#xD;
  The time points will be pre- (baseline) vs post-stimulation session.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phoneme blending (Experimental reading task)</measure>
      <time_frame>during procedure</time_frame>
      <description>Change in phoneme blending from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Phoneme blending is considered as the number of correctly blended phonemes.&#xD;
  The time points will be pre- (baseline) vs post-stimulation session.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Eye-movements during reading (Experimental reading task)</measure>
      <time_frame>during procedure</time_frame>
      <description>Change in eye-movements from baseline compared to after reading during Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Eye-movements during reading is considered as the number of saccades and the number of dwells.&#xD;
  The time points will be pre- (baseline) vs post-stimulation session.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Spontaneous EEG (Experimental reading task)</measure>
      <time_frame>during procedure</time_frame>
      <description>Change in spontaneous EEG from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Spontaneous EEG is considered as the individual alpha-peak frequency and the beta and theta/gamma oscillations.&#xD;
  The time points will be pre- (baseline) vs post-stimulation session.</description>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Developmental Dyslexia</condition>
    <arm_group>
      <arm_group_label>HD-tDCS V5/MT, HD-tDCS V1, Sham</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Active HD-tDCS over V5/MT&#xD;
  Active HD-tDCS over V1&#xD;
  Sham HD-tDCS over V5/MT or V1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HD-tDCS V5/MT, Sham, HD-tDCS V1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Active HD-tDCS over V5/MT&#xD;
  Sham HD-tDCS over V5/MT or V1&#xD;
  Active HD-tDCS over V1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HD-tDCS V1, HD-tDCS V5/MT, Sham</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Active HD-tDCS over V1&#xD;
  Active HD-tDCS over V5/MT&#xD;
  Sham HD-tDCS over V5/MT or V1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HD-tDCS V1, Sham, HD-tDCS V5/MT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Active HD-tDCS over V1&#xD;
  Sham HD-tDCS over V5/MT or V1&#xD;
  Active HD-tDCS over V5/MT</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham, HD-tDCS V5/MT, HD-tDCS V1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sham HD-tDCS over V5/MT or V1&#xD;
  Active HD-tDCS over V5/MT&#xD;
  Active HD-tDCS over V1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham, HD-tDCS V1, HD-tDCS V5/MT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sham HD-tDCS over V5/MT or V1&#xD;
  Active HD-tDCS over V1&#xD;
  Active HD-tDCS over V5/MT</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Active HD-tDCS over V5/MT</intervention_name>
      <description>For HD-tDCS a 4 × 1 montage (Kessler et al., 2013), small circular electrodes (diameter 1 cm) will be used with the anode placed centrally with a current intensity of 1 mA for a total of 20 minutes (30 s ramp up/down). Hereby, the anodal electrode modulates the excitability of the targeted area left V5/MT, whereas the other 4 electrodes return electrical currents that flow away from that area. V5/MT will be localised via published procedures and electrode's placement will be done according to the 10-20 International EEG 10-20 System for electrode placement.</description>
      <arm_group_label>HD-tDCS V1, HD-tDCS V5/MT, Sham</arm_group_label>
      <arm_group_label>HD-tDCS V1, Sham, HD-tDCS V5/MT</arm_group_label>
      <arm_group_label>HD-tDCS V5/MT, HD-tDCS V1, Sham</arm_group_label>
      <arm_group_label>HD-tDCS V5/MT, Sham, HD-tDCS V1</arm_group_label>
      <arm_group_label>Sham, HD-tDCS V1, HD-tDCS V5/MT</arm_group_label>
      <arm_group_label>Sham, HD-tDCS V5/MT, HD-tDCS V1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Active HD-tDCS over V1</intervention_name>
      <description>For HD-tDCS a 4 × 1 montage (Kessler et al., 2013), small circular electrodes (diameter 1 cm) will be used with the anode placed centrally with a current intensity of 1 mA for a total of 20 minutes (30 s ramp up/down). Hereby, the anodal electrode modulates the excitability of the targeted area left V1, whereas the other 4 electrodes return electrical currents that flow away from that area. V1 will be localised via published procedures and electrode's placement will be done according to the 10-20 International EEG 10-20 System for electrode placement.</description>
      <arm_group_label>HD-tDCS V1, HD-tDCS V5/MT, Sham</arm_group_label>
      <arm_group_label>HD-tDCS V1, Sham, HD-tDCS V5/MT</arm_group_label>
      <arm_group_label>HD-tDCS V5/MT, HD-tDCS V1, Sham</arm_group_label>
      <arm_group_label>HD-tDCS V5/MT, Sham, HD-tDCS V1</arm_group_label>
      <arm_group_label>Sham, HD-tDCS V1, HD-tDCS V5/MT</arm_group_label>
      <arm_group_label>Sham, HD-tDCS V5/MT, HD-tDCS V1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham HD-tDCS over V5/MT or V1</intervention_name>
      <description>Sham HD-tDCS will be delivered over left V5/MT or left V1. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down (0 mA) during the rest of the session without the participants awareness. .</description>
      <arm_group_label>HD-tDCS V1, HD-tDCS V5/MT, Sham</arm_group_label>
      <arm_group_label>HD-tDCS V1, Sham, HD-tDCS V5/MT</arm_group_label>
      <arm_group_label>HD-tDCS V5/MT, HD-tDCS V1, Sham</arm_group_label>
      <arm_group_label>HD-tDCS V5/MT, Sham, HD-tDCS V1</arm_group_label>
      <arm_group_label>Sham, HD-tDCS V1, HD-tDCS V5/MT</arm_group_label>
      <arm_group_label>Sham, HD-tDCS V5/MT, HD-tDCS V1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Italian speakers right-handed children and adolescents with dyslexia (DSM-5, APA&#xD;
               2013);&#xD;
  &#xD;
            -  Word/nonword/text reading accuracy and/or speed at least 2 Standard Deviations below&#xD;
               the mean for school-age;&#xD;
  &#xD;
            -  nv IQ ≥ 85;&#xD;
  &#xD;
            -  normal hearing and normal or corrected-to-normal vision.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a comorbidity with other primary psychiatric/neurological diagnosis (e.g.,&#xD;
               depression, anxiety, autism, ADHD);&#xD;
  &#xD;
            -  Having a personal history of neurological/medical/genetic diseases;&#xD;
  &#xD;
            -  Having ongoing drug treatment influencing brain function;&#xD;
  &#xD;
            -  Having epilepsy o family history of epilepsy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>13 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Deny Menghini</last_name>
      <phone>06.6859.2875</phone>
      <email>deny.menghini@opbg.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Giulia Lazzaro</last_name>
      <email>giulia.lazzaro@opbg.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Bambino Gesù Hospital and Research Institute</name>
        <address>
          <city>Roma</city>
          <zip>00165</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Deny Menghini</last_name>
        <phone>06.6859.2875</phone>
        <email>deny.menghini@opbg.net</email>
      </contact>
      <contact_backup>
        <last_name>Rita Alparone</last_name>
        <phone>06.6859.2859</phone>
        <email>rita.alparone@opbg.net</email>
      </contact_backup>
      <investigator>
        <last_name>Deny Menghini</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
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      <citation>Muller-Axt C, Anwander A, von Kriegstein K. Altered Structural Connectivity of the Left Visual Thalamus in Developmental Dyslexia. Curr Biol. 2017 Dec 4;27(23):3692-3698.e4. doi: 10.1016/j.cub.2017.10.034. Epub 2017 Nov 16.</citation>
      <PMID>29153326</PMID>
    </results_reference>
    <results_reference>
      <citation>Tschentscher N, Ruisinger A, Blank H, Diaz B, von Kriegstein K. Reduced Structural Connectivity Between Left Auditory Thalamus and the Motion-Sensitive Planum Temporale in Developmental Dyslexia. J Neurosci. 2019 Feb 27;39(9):1720-1732. doi: 10.1523/JNEUROSCI.1435-18.2018. Epub 2019 Jan 14.</citation>
      <PMID>30643025</PMID>
    </results_reference>
    <results_reference>
      <citation>Kirimoto H, Ogata K, Onishi H, Oyama M, Goto Y, Tobimatsu S. Transcranial direct current stimulation over the motor association cortex induces plastic changes in ipsilateral primary motor and somatosensory cortices. Clin Neurophysiol. 2011 Apr;122(4):777-83. doi: 10.1016/j.clinph.2010.09.025. Epub 2010 Nov 11.</citation>
      <PMID>21074492</PMID>
    </results_reference>
    <results_reference>
      <citation>Turkeltaub PE, Benson J, Hamilton RH, Datta A, Bikson M, Coslett HB. Left lateralizing transcranial direct current stimulation improves reading efficiency. Brain Stimul. 2012 Jul;5(3):201-207. doi: 10.1016/j.brs.2011.04.002. Epub 2011 May 5.</citation>
      <PMID>22305346</PMID>
    </results_reference>
    <results_reference>
      <citation>Younger JW, Randazzo Wagner M, Booth JR. Weighing the Cost and Benefit of Transcranial Direct Current Stimulation on Different Reading Subskills. Front Neurosci. 2016 Jun 7;10:262. doi: 10.3389/fnins.2016.00262. eCollection 2016.</citation>
      <PMID>27375421</PMID>
    </results_reference>
    <results_reference>
      <citation>Younger JW, Booth JR. Parietotemporal Stimulation Affects Acquisition of Novel Grapheme-Phoneme Mappings in Adult Readers. Front Hum Neurosci. 2018 Mar 23;12:109. doi: 10.3389/fnhum.2018.00109. eCollection 2018.</citation>
      <PMID>29628882</PMID>
    </results_reference>
    <results_reference>
      <citation>Heth I, Lavidor M. Improved reading measures in adults with dyslexia following transcranial direct current stimulation treatment. Neuropsychologia. 2015 Apr;70:107-13. doi: 10.1016/j.neuropsychologia.2015.02.022. Epub 2015 Feb 19.</citation>
      <PMID>25701796</PMID>
    </results_reference>
    <results_reference>
      <citation>Costanzo F, Varuzza C, Rossi S, Sdoia S, Varvara P, Oliveri M, Koch G, Vicari S, Menghini D. Reading changes in children and adolescents with dyslexia after transcranial direct current stimulation. Neuroreport. 2016 Mar 23;27(5):295-300. doi: 10.1097/WNR.0000000000000536.</citation>
      <PMID>26848997</PMID>
    </results_reference>
    <results_reference>
      <citation>Costanzo F, Varuzza C, Rossi S, Sdoia S, Varvara P, Oliveri M, Giacomo K, Vicari S, Menghini D. Evidence for reading improvement following tDCS treatment in children and adolescents with Dyslexia. Restor Neurol Neurosci. 2016;34(2):215-26. doi: 10.3233/RNN-150561.</citation>
      <PMID>26890096</PMID>
    </results_reference>
    <results_reference>
      <citation>Costanzo F, Rossi S, Varuzza C, Varvara P, Vicari S, Menghini D. Long-lasting improvement following tDCS treatment combined with a training for reading in children and adolescents with dyslexia. Neuropsychologia. 2019 Jul;130:38-43. doi: 10.1016/j.neuropsychologia.2018.03.016. Epub 2018 Mar 14.</citation>
      <PMID>29550525</PMID>
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    <results_reference>
      <citation>Rios DM, Correia Rios M, Bandeira ID, Queiros Campbell F, de Carvalho Vaz D, Lucena R. Impact of Transcranial Direct Current Stimulation on Reading Skills of Children and Adolescents With Dyslexia. Child Neurol Open. 2018 Oct 4;5:2329048X18798255. doi: 10.1177/2329048X18798255. eCollection 2018.</citation>
      <PMID>30306098</PMID>
    </results_reference>
    <results_reference>
      <citation>Lazzaro G, Costanzo F, Varuzza C, Rossi S, De Matteis ME, Vicari S, Menghini D. Individual differences modulate the effects of tDCS on reading in children and adolescents with dyslexia. Scientific Studies of Reading. 2021; 25(6): 1-17.</citation>
    </results_reference>
    <results_reference>
      <citation>Lazzaro G, Costanzo F, Varuzza C, Rossi S, Vicari S, Menghini D. Effects of a short, intensive, multi-session tDCS treatment in developmental dyslexia: Preliminary results of a sham-controlled randomized clinical trial. Prog Brain Res. 2021;264:191-210. doi: 10.1016/bs.pbr.2021.01.015.</citation>
      <PMID>34167656</PMID>
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    <results_reference>
      <citation>Battisti A, Lazzaro G, Costanzo F, Varuzza C, Rossi S, Vicari S, Menghini D. Effects of a short and intensive transcranial direct current stimulation treatment in children and adolescents with developmental dyslexia: A crossover clinical trial. Front Psychol. 2022 Sep 9;13:986242. doi: 10.3389/fpsyg.2022.986242. eCollection 2022.</citation>
      <PMID>36160506</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bambino Gesù Hospital and Research Institute</investigator_affiliation>
      <investigator_full_name>Deny Menghini</investigator_full_name>
      <investigator_title>Head of Psychology Unit</investigator_title>
    </responsible_party>
    <keyword>Children</keyword>
    <keyword>Adolescents</keyword>
    <keyword>tDCS</keyword>
    <keyword>transcranial direct current stimulation</keyword>
    <keyword>neurodevelopmental disorders</keyword>
    <keyword>non-invasive brain stimulation</keyword>
    <keyword>transcranial electrical stimulation</keyword>
    <keyword>EEG</keyword>
    <keyword>reading abilities</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyslexia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05972200
  org study id: 3073_OPBG_2023
  nct id: NCT05972200
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present study grounds on the absence of evidence-based treatment in individuals with
        developmental dyslexia (DD). At this topic, the present study will explore the potential
        effect of transcranial direct current stimulation (tDCS) over left hemispheric direct Lateral
        Geniculate Nucleus (LGN)-V5/MT pathway, cerebral areas usually disrupted in individuals with
        DD.
  
        The investigators hypothesized that active tDCS over V5/MT will boost reading skills in
        children and adolescents with DD. On the contrary, sham (placebo condition) tDCS over V5/MT
        or active (control condition) tDCS over V1 will not have significant effect in improving
        reading skills. Further, both active and sham tDCS will be safe and well tolerated.
  Over the last few decades, a huge number of studies has revealed that Developmental Dyslexia
        (DD), a brain-based neurodevelopmental disorder characterized by a severe and persistent
        impairment in the acquisition of reading skills may depend on multiple neurocognitive
        impairments, ranging from language-specific to cognitive-general deficits. Besides the most
        influential hypothesis of a phonological core deficit, there is also evidence for
        difficulties in low-level visual-temporal information processing, as the magnocellular
        deficit theory supports, as well as for visual-spatial attentional deficits,
        visual-perceptual impairments, and rapid automatized naming (RAN)-speed deficits.
  
        Replicated structural/functional neuroimaging studies have demonstrated a DD hypoactivation
        relative to typical readers in the left temporo-occipital regions-critical for the automatic
        visual processing of word strings or print-and in the left temporo-parietal regions-important
        for grapheme-to-phoneme mapping.
  
        Moreover, findings from animal models and post mortem studies in humans suggest that DD might
        also be associated with structural alterations in subcortical sensory pathways, particularly
        in visual and auditory thalamic nuclei and in their connections with high-order sensory
        cortices (i.e., the left hemispheric direct Lateral Geniculate Nucleus (LGN)-V5/MT pathway
        and the left hemispheric direct Medial Geniculate Body (MGB)-mPT pathway). In addition, in
        adults with DD, left V5/MT-LGN connectivity strength correlated with RAN abilities - a key
        deficit in DD.
  
        A number of studies have demonstrated the positive effect of transcranial direct current
        stimulation (tDCS), a non-invasive brain stimulation used for transiently modifying neural
        activity of target areas, on reading and, particularly, in DD.
  
        However, the few non-invasive brain stimulation studies on improving reading in DD yielded
        heterogeneous results and this variability might be partly due to the lack of neurobiological
        understanding of the underlying DD mechanism or to the use of traditional tDCS rather than a
        more focal technique such as the high-definition tDCS (HD-tDCS).
  
        Starting from this, the aim of the current study is testing the effectiveness of a
        cutting-edge stimulation technique (i.e., HD-tDCS) in a within-subject experiment involving
        children and adolescents with DD. Especially, we will work to test i) the specific effect of
        HD-tDCS over high-order sensory cortices (i.e., V5/MT vs V1) on reading in children with DD;
        ii) the preconditions and neurobiological mechanisms that lead to high treatment outcomes.
  
        If the stimulation over V5/MT is effective and specifically related to reading improvement,
        our results could help to i) understand the contribution and neurobiological mechanism of
        V5/MT in reading of children and adolescents with DD; ii) select criteria for potential
        responders to non-invasive brain stimulation; iii) develop evidence-based interventions in
        DD.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Text reading accuracy (Experimental reading task)
  time frame: during procedure
  description: Change in text reading accuracy from baseline compared after to Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Text reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.
  The time points will be pre- (baseline) vs post-stimulation session.
  measure: Text reading speed (Experimental reading task)
  time frame: during procedure
  description: Change in text reading speed from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Text reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).
  The time points will be pre- (baseline) vs post-stimulation session.
  measure: Word reading accuracy (Experimental reading task)
  time frame: during procedure
  description: Change in word reading accuracy from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Word reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.
  The time points will be pre- (baseline) vs post-stimulation session.
  measure: Word reading speed (Experimental reading task)
  time frame: during procedure
  description: Change in word reading speed from baseline compared to after Active HD-tDCS over V5/MT sessions than during Active HD-tDCS over V1 and Sham sessions. Word reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).
  The time points will be pre- (baseline) vs post-stimulation session.
  measure: Non-word reading accuracy (Experimental reading task)
  time frame: during procedure
  description: Change in non-word reading accuracy from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Non-word reading accuracy is considered as the percentage (%) of accuracy and computed as the ratio between the number of correctly read stimuli and the total number of stimuli presented multiplied by 100.
  The time points will be pre- (baseline) vs post-stimulation session.
  measure: Non-word reading speed (Experimental reading task)
  time frame: during procedure
  description: Change in non-word reading speed from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Non-word reading speed is considered as the syllables/seconds ratio and calculated dividing the total number of syllables pronounced by the total time spent to complete the reading (in seconds).
  The time points will be pre- (baseline) vs post-stimulation session.
  measure: Right visual hemisphere-motion perception (Experimental reading task)
  time frame: during procedure
  description: Change in right visual hemisphere-motion perception from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Right visual hemisphere-motion perception is considered as the number of correct saccades.
  The time points will be pre- (baseline) vs post-stimulation session.
  measure: Rapid automatized naming letter and number (Experimental reading task)
  time frame: during procedure
  description: Change in rapid automatized naming letter and number from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Rapid automatized naming letter and number is considered as the total time spent (in seconds) to complete the task.
  The time points will be pre- (baseline) vs post-stimulation session.
  measure: Phoneme blending (Experimental reading task)
  time frame: during procedure
  description: Change in phoneme blending from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Phoneme blending is considered as the number of correctly blended phonemes.
  The time points will be pre- (baseline) vs post-stimulation session.
  measure: Eye-movements during reading (Experimental reading task)
  time frame: during procedure
  description: Change in eye-movements from baseline compared to after reading during Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Eye-movements during reading is considered as the number of saccades and the number of dwells.
  The time points will be pre- (baseline) vs post-stimulation session.
  measure: Spontaneous EEG (Experimental reading task)
  time frame: during procedure
  description: Change in spontaneous EEG from baseline compared to after Active HD-tDCS over V5/MT sessions than after Active HD-tDCS over V1 and Sham sessions. Spontaneous EEG is considered as the individual alpha-peak frequency and the beta and theta/gamma oscillations.
  The time points will be pre- (baseline) vs post-stimulation session.
  arm group label: HD-tDCS V5/MT, HD-tDCS V1, Sham
  arm group type: Experimental
  description: Active HD-tDCS over V5/MT
  Active HD-tDCS over V1
  Sham HD-tDCS over V5/MT or V1
  arm group label: HD-tDCS V5/MT, Sham, HD-tDCS V1
  arm group type: Experimental
  description: Active HD-tDCS over V5/MT
  Sham HD-tDCS over V5/MT or V1
  Active HD-tDCS over V1
  arm group label: HD-tDCS V1, HD-tDCS V5/MT, Sham
  arm group type: Experimental
  description: Active HD-tDCS over V1
  Active HD-tDCS over V5/MT
  Sham HD-tDCS over V5/MT or V1
  arm group label: HD-tDCS V1, Sham, HD-tDCS V5/MT
  arm group type: Experimental
  description: Active HD-tDCS over V1
  Sham HD-tDCS over V5/MT or V1
  Active HD-tDCS over V5/MT
  arm group label: Sham, HD-tDCS V5/MT, HD-tDCS V1
  arm group type: Experimental
  description: Sham HD-tDCS over V5/MT or V1
  Active HD-tDCS over V5/MT
  Active HD-tDCS over V1
  arm group label: Sham, HD-tDCS V1, HD-tDCS V5/MT
  arm group type: Experimental
  description: Sham HD-tDCS over V5/MT or V1
  Active HD-tDCS over V1
  Active HD-tDCS over V5/MT
  intervention type: Device
  intervention name: Active HD-tDCS over V5/MT
  description: For HD-tDCS a 4 × 1 montage (Kessler et al., 2013), small circular electrodes (diameter 1 cm) will be used with the anode placed centrally with a current intensity of 1 mA for a total of 20 minutes (30 s ramp up/down). Hereby, the anodal electrode modulates the excitability of the targeted area left V5/MT, whereas the other 4 electrodes return electrical currents that flow away from that area. V5/MT will be localised via published procedures and electrode's placement will be done according to the 10-20 International EEG 10-20 System for electrode placement.
  arm group label: HD-tDCS V1, HD-tDCS V5/MT, Sham
  arm group label: HD-tDCS V1, Sham, HD-tDCS V5/MT
  arm group label: HD-tDCS V5/MT, HD-tDCS V1, Sham
  arm group label: HD-tDCS V5/MT, Sham, HD-tDCS V1
  arm group label: Sham, HD-tDCS V1, HD-tDCS V5/MT
  arm group label: Sham, HD-tDCS V5/MT, HD-tDCS V1
  intervention type: Device
  intervention name: Active HD-tDCS over V1
  description: For HD-tDCS a 4 × 1 montage (Kessler et al., 2013), small circular electrodes (diameter 1 cm) will be used with the anode placed centrally with a current intensity of 1 mA for a total of 20 minutes (30 s ramp up/down). Hereby, the anodal electrode modulates the excitability of the targeted area left V1, whereas the other 4 electrodes return electrical currents that flow away from that area. V1 will be localised via published procedures and electrode's placement will be done according to the 10-20 International EEG 10-20 System for electrode placement.
  arm group label: HD-tDCS V1, HD-tDCS V5/MT, Sham
  arm group label: HD-tDCS V1, Sham, HD-tDCS V5/MT
  arm group label: HD-tDCS V5/MT, HD-tDCS V1, Sham
  arm group label: HD-tDCS V5/MT, Sham, HD-tDCS V1
  arm group label: Sham, HD-tDCS V1, HD-tDCS V5/MT
  arm group label: Sham, HD-tDCS V5/MT, HD-tDCS V1
  intervention type: Device
  intervention name: Sham HD-tDCS over V5/MT or V1
  description: Sham HD-tDCS will be delivered over left V5/MT or left V1. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down (0 mA) during the rest of the session without the participants awareness. .
  arm group label: HD-tDCS V1, HD-tDCS V5/MT, Sham
  arm group label: HD-tDCS V1, Sham, HD-tDCS V5/MT
  arm group label: HD-tDCS V5/MT, HD-tDCS V1, Sham
  arm group label: HD-tDCS V5/MT, Sham, HD-tDCS V1
  arm group label: Sham, HD-tDCS V1, HD-tDCS V5/MT
  arm group label: Sham, HD-tDCS V5/MT, HD-tDCS V1
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 13 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Deny Menghini
  phone: 06.6859.2875
  email: deny.menghini@opbg.net
  last name: Giulia Lazzaro
  email: giulia.lazzaro@opbg.net
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Italy
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  citation: Tschentscher N, Ruisinger A, Blank H, Diaz B, von Kriegstein K. Reduced Structural Connectivity Between Left Auditory Thalamus and the Motion-Sensitive Planum Temporale in Developmental Dyslexia. J Neurosci. 2019 Feb 27;39(9):1720-1732. doi: 10.1523/JNEUROSCI.1435-18.2018. Epub 2019 Jan 14.
  PMID: 30643025
  citation: Kirimoto H, Ogata K, Onishi H, Oyama M, Goto Y, Tobimatsu S. Transcranial direct current stimulation over the motor association cortex induces plastic changes in ipsilateral primary motor and somatosensory cortices. Clin Neurophysiol. 2011 Apr;122(4):777-83. doi: 10.1016/j.clinph.2010.09.025. Epub 2010 Nov 11.
  PMID: 21074492
  citation: Turkeltaub PE, Benson J, Hamilton RH, Datta A, Bikson M, Coslett HB. Left lateralizing transcranial direct current stimulation improves reading efficiency. Brain Stimul. 2012 Jul;5(3):201-207. doi: 10.1016/j.brs.2011.04.002. Epub 2011 May 5.
  PMID: 22305346
  citation: Younger JW, Randazzo Wagner M, Booth JR. Weighing the Cost and Benefit of Transcranial Direct Current Stimulation on Different Reading Subskills. Front Neurosci. 2016 Jun 7;10:262. doi: 10.3389/fnins.2016.00262. eCollection 2016.
  PMID: 27375421
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  PMID: 36160506
  responsible party type: Principal Investigator
  investigator affiliation: Bambino Gesù Hospital and Research Institute
  investigator full name: Deny Menghini
  investigator title: Head of Psychology Unit
  mesh term: Dyslexia
  sharing ipd: No