<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/NCT03797638</url>
  </required_header>
  <id_info>
    <org_study_id>SSA_2018_4</org_study_id>
    <nct_id>NCT03797638</nct_id>
  </id_info>
  <brief_title>Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects</brief_title>
  <acronym>FFM_CT</acronym>
  <official_title>Characterization of Manual Dexterity by Finger Force Manipuladum (FFM) in Patients With Writer's Cramp and in Control Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Writer's cramp is a focal dystonia characterized by abnormal movements and postures during&#xD;
      writing. Limited finger independence during writing manifests as difficulty suppressing&#xD;
      unwanted activations of neighbouring non task-relevant fingers. Patients with Writer's cramp&#xD;
      also have difficulty in fine control of grip force.&#xD;
&#xD;
      The investigators have recently developed the Finger Force Manipulandum which quantifies the&#xD;
      forces applied by each fingers in different tasks. This method is sensitive for detection and&#xD;
      quantification of small unwanted contractions in non-active ('stationary') fingers. Different&#xD;
      tasks have been developed to assess abilities such as finger individuation but also fine&#xD;
      finger force control, finger movement regularity and speed.&#xD;
&#xD;
      The aim of this study is to assess if developed tasks allow to precisely characterize&#xD;
      writer's cramp condition in terms of abilities aforementioned.&#xD;
&#xD;
      To do so, performance of 20 writer's cramp patients in the developed task will be compared&#xD;
      with performance of 20 control participants (matched in age, sex and writing hand) in the&#xD;
      same tasks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">July 19, 2019</completion_date>
  <primary_completion_date type="Actual">July 19, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Manual dexterity by the FFM</measure>
    <time_frame>Inclusion</time_frame>
    <description>Compare the manual dexterity by the FFM between subjects with writer's cramp and control subject</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Dystonic Disorder</condition>
  <condition>Focal Dystonia</condition>
  <condition>Writer's Cramp</condition>
  <arm_group>
    <arm_group_label>Patients with writer's cramp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with writer's cramp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control subjects, without writer's cramp, matched with case subjects with age, gender and hand writing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Finger Force Manipuladum (FFM)</intervention_name>
    <description>Tasks performed with the device Finger Force Manipuladum (FFM), to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.</description>
    <arm_group_label>Control subjects</arm_group_label>
    <arm_group_label>Patients with writer's cramp</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for patients with writer's cramp&#xD;
&#xD;
          -  Patient with writer's cramp and writing speed &lt;140 letters / min&#xD;
&#xD;
          -  Writer's cramp focal dystonia specific to the task of writing&#xD;
&#xD;
          -  Patient treated or not with botulinum toxin injection&#xD;
&#xD;
          -  Person having attended school in French&#xD;
&#xD;
        Non inclusion criteria for patients with writer's cramp&#xD;
&#xD;
          -  Patients whose writer's cramp has no impact on the handwriting and has kept a writing&#xD;
             speed&gt; 140 letters per minute.&#xD;
&#xD;
          -  Tremor of writing&#xD;
&#xD;
          -  Neurological condition other than writer's cramp (eg Parkinson's syndrome)&#xD;
&#xD;
          -  Pain, trauma or pathology of the upper limb of the writing member other than the&#xD;
             writer's cramp who required medical or surgical treatment in the last 6 months&#xD;
             preceding the initial check-up&#xD;
&#xD;
        Inclusion criteria for control subjects&#xD;
&#xD;
        •&gt; 18 years old&#xD;
&#xD;
          -  Without writer's cramp&#xD;
&#xD;
          -  Person having attended school in French&#xD;
&#xD;
        Non inclusion criteria for control subjects&#xD;
&#xD;
          -  Tremor of writing&#xD;
&#xD;
          -  Neurological condition other than writer's cramp (eg Parkinson's syndrome)&#xD;
&#xD;
          -  Pain, trauma or pathology of the upper limb of the writing member other than the&#xD;
             writer's cramp who required medical or surgical treatment in the last 6 months&#xD;
             preceding the initial check-up&#xD;
&#xD;
        Matching criteria between cases and control patients&#xD;
&#xD;
          -  Age (± 5 years)&#xD;
&#xD;
          -  Gender&#xD;
&#xD;
          -  Hand writing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Pierre BLETON, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation A. de Rothschild</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondation A 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>June 2021</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>June 20, 2021</last_update_submitted>
  <last_update_submitted_qc>June 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dystonic Disorder</keyword>
  <keyword>Focal Dystonia</keyword>
  <keyword>Writer's Cramp</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Cramp</mesh_term>
    <mesh_term>Dystonia</mesh_term>
    <mesh_term>Dystonic Disorders</mesh_term>
    <mesh_term>Spasm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03797638
org study id: SSA_2018_4
nct id: NCT03797638
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Writer's cramp is a focal dystonia characterized by abnormal movements and postures during
      writing. Limited finger independence during writing manifests as difficulty suppressing
      unwanted activations of neighbouring non task-relevant fingers. Patients with Writer's cramp
      also have difficulty in fine control of grip force.

      The investigators have recently developed the Finger Force Manipulandum which quantifies the
      forces applied by each fingers in different tasks. This method is sensitive for detection and
      quantification of small unwanted contractions in non-active ('stationary') fingers. Different
      tasks have been developed to assess abilities such as finger individuation but also fine
      finger force control, finger movement regularity and speed.

      The aim of this study is to assess if developed tasks allow to precisely characterize
      writer's cramp condition in terms of abilities aforementioned.

      To do so, performance of 20 writer's cramp patients in the developed task will be compared
      with performance of 20 control participants (matched in age, sex and writing hand) in the
      same tasks.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Manual dexterity by the FFM
time frame: Inclusion
description: Compare the manual dexterity by the FFM between subjects with writer's cramp and control subject
arm group label: Patients with writer's cramp
arm group type: Experimental
description: Patients with writer's cramp
arm group label: Control subjects
arm group type: Other
description: Control subjects, without writer's cramp, matched with case subjects with age, gender and hand writing
intervention type: Device
intervention name: Finger Force Manipuladum (FFM)
description: Tasks performed with the device Finger Force Manipuladum (FFM), to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.
arm group label: Control subjects
arm group label: Patients with writer's cramp
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Pierre BLETON, PhD
role: Principal Investigator
affiliation: Fondation A. de Rothschild
facility: 
country: France
responsible party type: Sponsor
mesh term: Muscle Cramp
mesh term: Dystonia
mesh term: Dystonic Disorders
mesh term: Spasm
sharing ipd: Undecided