<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/NCT03235596</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A00805-46</org_study_id>
    <nct_id>NCT03235596</nct_id>
  </id_info>
  <brief_title>Effects of Cathodal tDCS on Executive Functions in Autism</brief_title>
  <acronym>TRANSFEX</acronym>
  <official_title>Pilot Study Investigating the Effects of Cathodal Transcranial Direct Current Stimulation (tDCS) on Executive Functions of Patients With Autism Without Mental Retardation. TRANSFEX Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier du Rouvray</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier du Rouvray</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>
      It's an interventional, prospective and monocentric pilot study concerning adult patients&#xD;
      with autism without mental retardation.&#xD;
&#xD;
      The primary outcome is to assess the effects of cathodal transcranial direct current&#xD;
      stimulation (tDCS) on the left dorsolateral prefrontal cortex (DLPFC) on the executive&#xD;
      functions of patients with autism without mental retardation or with Asperger syndrome.&#xD;
&#xD;
      The secondary outcomes are to evaluate the safety of this treatment and to evaluate its&#xD;
      impact on impaired social communication and on restricted or repetitive behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients concerned by the study are aged 20 to 50 years old. They meet ICD-10 criteria&#xD;
      for autism without mental retardation or Asperger syndrome and they have adaptive capacity&#xD;
      and autonomy complaints. They stable treatments for at least 4 weeks prior and during all the&#xD;
      study and no history of tDCS. Women of childbearing age with no adequate contraception,&#xD;
      pregnant or lactating women are excluded.&#xD;
&#xD;
      This is an interventional, prospective and monocentric pilot study. The patient is informed&#xD;
      about the clinical study during the psychiatric consultation. The patient is provided with a&#xD;
      cooling-off period of several days. During the inclusion visit, the executive functions of&#xD;
      the patient are assessed (WSCT, Stroop, TMT A and B and verbal fluency test). If 2&#xD;
      pathological tests are found among all measured scores: administration of ISDC and EC2R&#xD;
      (interview of the person accompanying) and planning of the first tDCS session 15 days later.&#xD;
      If no pathological test is found : study exit.&#xD;
&#xD;
      The treatment consists in 10 sessions of cathodal tDCS applied over the left dorsolateral&#xD;
      prefrontal cortex (DLPFC) at 2mA. Each session lasts 15 minutes. They are 2 sessions per day.&#xD;
&#xD;
      Ten days after the end of tDCS treatment, patients are assessed for executive functions and&#xD;
      behavioral dysexecutive functions (EC2R and ISCD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>It's an interventional, prospective and monocentric pilot study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive dysexecutive functions</measure>
    <time_frame>30 days</time_frame>
    <description>Score changes in Wisconsin Card Sorting test between assessment at day 1(inclusion) and assessment at day 30 (end of the study).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale</measure>
    <time_frame>30 days</time_frame>
    <description>Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale between assessment at day 1 (inclusion), assessment at day 20 and assessment day 30 (end of the study).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral dysexecutive functions</measure>
    <time_frame>30 days</time_frame>
    <description>Score changes in the behavioral dysexecutive syndrome battery (Inventaire du Syndrome Dysexécutif Comportemental, ISDC) and the restricted and repetitive behaviors rating scale (Echelle d'évaluation des Comportements Répétitifs et Restreints, EC2R) between assessment at day 1 (inclusion) and assessment at day 30 (end of the study) (interview of the person accompanying).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trail Making Test A and B</measure>
    <time_frame>30 days</time_frame>
    <description>Score changes in the Trail Making test A and B between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop Test</measure>
    <time_frame>30 days</time_frame>
    <description>Score changes in the Stroop between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal Fluency Test</measure>
    <time_frame>30 days</time_frame>
    <description>Score changes in Verbal Fluency Test between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>treated arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2 mA during 15 minutes. They have 10 sessions in 5 consecutive days, 2 sessions per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2mA during 15 minutes</description>
    <arm_group_label>treated arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With ICD-10 criteria for autism without mental retardation or Asperger syndrome;&#xD;
&#xD;
          -  Patient with adaptive capacity and autonomy complaints.&#xD;
&#xD;
          -  Patients with stable treatments for at least 4 weeks prior and during all the study;&#xD;
&#xD;
          -  Patient with no history of tDCS;&#xD;
&#xD;
          -  Patients affiliated to a social security system;&#xD;
&#xD;
          -  Patients who give their informed written consents;&#xD;
&#xD;
          -  For women of childbearing age: effective contraception; required (estrogen and&#xD;
             progestogen or intra-uterine device or tubal ligation) for at least 1 month before&#xD;
             starting treatment (a negative pregnancy test has been obtained).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skin disease, dementia, history of epileptic seizures, brain tumor or metallic&#xD;
             implants/implanted electrical devices.&#xD;
&#xD;
          -  Patients who followed à cognitive remediation program during the last 6 months;&#xD;
&#xD;
          -  Subjects currently treated with magnetic or electrical stimulation techniques (e.g.:&#xD;
             transcutaneous or root stimulation).&#xD;
&#xD;
          -  Women of childbearing age with no adequate contraception, pregnant or lactating women;&#xD;
&#xD;
          -  Patients participating or having participated in an interventional clinical trial&#xD;
             within 30 days prior to the inclusion visit;&#xD;
&#xD;
          -  Subjects who are deprived of their liberty by decision of a judicial or administrative&#xD;
             authority.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Maud ROTHARMEL, MD</last_name>
    <email>maud.rotharmel@ch-lerouvray.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Martine REYMOND</last_name>
    <email>martine.reymond@ch-lerouvray.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier du Rouvray</name>
      <address>
        <city>Sotteville-lès-Rouen</city>
        <zip>76300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maud ROTHARMEL, MD</last_name>
      <email>maud.rotharmel@ch-lerouvray.fr</email>
    </contact>
    <contact_backup>
      <last_name>Martine Reymond</last_name>
      <email>martine.reymond@ch-lerouvray.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>June 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>executive functions</keyword>
  <keyword>tDCS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03235596
org study id: 2016-A00805-46
nct id: NCT03235596
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It's an interventional, prospective and monocentric pilot study concerning adult patients
      with autism without mental retardation.

      The primary outcome is to assess the effects of cathodal transcranial direct current
      stimulation (tDCS) on the left dorsolateral prefrontal cortex (DLPFC) on the executive
      functions of patients with autism without mental retardation or with Asperger syndrome.

      The secondary outcomes are to evaluate the safety of this treatment and to evaluate its
      impact on impaired social communication and on restricted or repetitive behaviors.
The patients concerned by the study are aged 20 to 50 years old. They meet ICD-10 criteria
      for autism without mental retardation or Asperger syndrome and they have adaptive capacity
      and autonomy complaints. They stable treatments for at least 4 weeks prior and during all the
      study and no history of tDCS. Women of childbearing age with no adequate contraception,
      pregnant or lactating women are excluded.

      This is an interventional, prospective and monocentric pilot study. The patient is informed
      about the clinical study during the psychiatric consultation. The patient is provided with a
      cooling-off period of several days. During the inclusion visit, the executive functions of
      the patient are assessed (WSCT, Stroop, TMT A and B and verbal fluency test). If 2
      pathological tests are found among all measured scores: administration of ISDC and EC2R
      (interview of the person accompanying) and planning of the first tDCS session 15 days later.
      If no pathological test is found : study exit.

      The treatment consists in 10 sessions of cathodal tDCS applied over the left dorsolateral
      prefrontal cortex (DLPFC) at 2mA. Each session lasts 15 minutes. They are 2 sessions per day.

      Ten days after the end of tDCS treatment, patients are assessed for executive functions and
      behavioral dysexecutive functions (EC2R and ISCD).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: It's an interventional, prospective and monocentric pilot study.
primary purpose: Treatment
masking: None (Open Label)
measure: Cognitive dysexecutive functions
time frame: 30 days
description: Score changes in Wisconsin Card Sorting test between assessment at day 1(inclusion) and assessment at day 30 (end of the study).
measure: Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale
time frame: 30 days
description: Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale between assessment at day 1 (inclusion), assessment at day 20 and assessment day 30 (end of the study).
measure: Behavioral dysexecutive functions
time frame: 30 days
description: Score changes in the behavioral dysexecutive syndrome battery (Inventaire du Syndrome Dysexécutif Comportemental, ISDC) and the restricted and repetitive behaviors rating scale (Echelle d'évaluation des Comportements Répétitifs et Restreints, EC2R) between assessment at day 1 (inclusion) and assessment at day 30 (end of the study) (interview of the person accompanying).
measure: Trail Making Test A and B
time frame: 30 days
description: Score changes in the Trail Making test A and B between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).
measure: Stroop Test
time frame: 30 days
description: Score changes in the Stroop between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).
measure: Verbal Fluency Test
time frame: 30 days
description: Score changes in Verbal Fluency Test between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).
arm group label: treated arm
arm group type: Experimental
description: Patients received cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2 mA during 15 minutes. They have 10 sessions in 5 consecutive days, 2 sessions per day.
intervention type: Device
intervention name: tDCS
description: cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2mA during 15 minutes
arm group label: treated arm
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Maud ROTHARMEL, MD
email: maud.rotharmel@ch-lerouvray.fr
last name: Martine REYMOND
email: martine.reymond@ch-lerouvray.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No