<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/NCT03270189</url>
  </required_header>
  <id_info>
    <org_study_id>SSA_2016_23</org_study_id>
    <nct_id>NCT03270189</nct_id>
  </id_info>
  <brief_title>Effect of the Visual Information Change in Functional Dystonia</brief_title>
  <acronym>PRISMADYS</acronym>
  <official_title>Effect of the Visual Information Change in Functional Dystonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</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>
      Cervical dystonia occurring only during the writing task is a rare form for which there is no&#xD;
      established treatment. Many authors agree that alteration of sensory integration is&#xD;
      associated with dystonia. Similar disturbances in the integration of oculomotor information&#xD;
      could have a role in cervical dystonia forms involving visuo-cervico-manual coordination such&#xD;
      as handwriting. We hypothesize that orthoptic treatment by wearing prisms when writing (i)&#xD;
      will reduce the abnormal posture of the head occurring whilst writing and remove the&#xD;
      associated nuchal pain; (ii) the correction after a period of systematic wearing of the&#xD;
      prisms during handwriting tasks will have a sustainable effect allowing to keep a normal head&#xD;
      position after the suppression of the prisms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">September 19, 2022</completion_date>
  <primary_completion_date type="Actual">December 19, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>measure of head movement occurring when writing</measure>
    <time_frame>3 months</time_frame>
    <description>Difference of the angle measured with and without corrective prisms during the handwriting tasks</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Dystonia</condition>
  <condition>Dystonic Disorders</condition>
  <condition>Torticollis</condition>
  <condition>Movement Disorders</condition>
  <condition>Central Nervous System Diseases</condition>
  <condition>Nervous System Diseases</condition>
  <condition>Dyskinesias</condition>
  <condition>Neurologic Manifestations</condition>
  <arm_group>
    <arm_group_label>orthoptic treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with cervical dystonia occuring only during handwriting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients without cervical dystonia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>prism glasses</intervention_name>
    <description>orthoptic treatment by wearing prisms when writing</description>
    <arm_group_label>orthoptic treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Case&#xD;
&#xD;
          -  Presenting a cervical dystonia that occurs only during handwriting tasks, diagnosed by&#xD;
             a neurologist specialised in movement disorders&#xD;
&#xD;
          -  Being treated or not by injection of Botulinum Neurotoxin (but last injection &gt; 3&#xD;
             months before the initial assessment)&#xD;
&#xD;
        Control&#xD;
&#xD;
          -  No cervical dystonia&#xD;
&#xD;
          -  Same sex, age (± 5 years), socio-professional level and hand laterality as the cases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Case&#xD;
&#xD;
          -  Cervical dystonia occuring in other circumstances than handwriting&#xD;
&#xD;
          -  Neurological disease other than cervical dystonia (e.g. Parkinson's syndrome)&#xD;
&#xD;
          -  Pain, trauma or pathology of the cervical spine of another cause than cervical&#xD;
             dystonia and which have required medical or surgical treatment in the last 6 months&#xD;
             preceding the initial assessment&#xD;
&#xD;
        Control&#xD;
&#xD;
          -  Cervical disorders requiring medical or surgical treatment in the last 6 months prior&#xD;
             to the tests&#xD;
&#xD;
          -  Neurological disease affecting the cervical region or the writing hand&#xD;
&#xD;
          -  Uncorrected visual disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>71 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Pierre Bleton, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Fondation Ophtalmologique Adolphe de Rothschild</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondation Ophtalmique Adolphe de Rothschild</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>February 11, 2023</last_update_submitted>
  <last_update_submitted_qc>February 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 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>Dystonia</mesh_term>
    <mesh_term>Dystonic Disorders</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Dyskinesias</mesh_term>
    <mesh_term>Movement Disorders</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
    <mesh_term>Neurologic Manifestations</mesh_term>
    <mesh_term>Torticollis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03270189
org study id: SSA_2016_23
nct id: NCT03270189
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cervical dystonia occurring only during the writing task is a rare form for which there is no
      established treatment. Many authors agree that alteration of sensory integration is
      associated with dystonia. Similar disturbances in the integration of oculomotor information
      could have a role in cervical dystonia forms involving visuo-cervico-manual coordination such
      as handwriting. We hypothesize that orthoptic treatment by wearing prisms when writing (i)
      will reduce the abnormal posture of the head occurring whilst writing and remove the
      associated nuchal pain; (ii) the correction after a period of systematic wearing of the
      prisms during handwriting tasks will have a sustainable effect allowing to keep a normal head
      position after the suppression of the prisms.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: measure of head movement occurring when writing
time frame: 3 months
description: Difference of the angle measured with and without corrective prisms during the handwriting tasks
arm group label: orthoptic treatment
arm group type: Experimental
description: Patients with cervical dystonia occuring only during handwriting.
arm group label: Controls
arm group type: No Intervention
description: Patients without cervical dystonia.
intervention type: Device
intervention name: prism glasses
description: orthoptic treatment by wearing prisms when writing
arm group label: orthoptic treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 71 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Pierre Bleton, PhD
role: Study Chair
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
facility: 
country: France
responsible party type: Sponsor
mesh term: Dystonia
mesh term: Dystonic Disorders
mesh term: Nervous System Diseases
mesh term: Dyskinesias
mesh term: Movement Disorders
mesh term: Central Nervous System Diseases
mesh term: Neurologic Manifestations
mesh term: Torticollis