<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/NCT02199015</url>
  </required_header>
  <id_info>
    <org_study_id>Andreani, JCM 1</org_study_id>
    <nct_id>NCT02199015</nct_id>
  </id_info>
  <brief_title>Lateral Cord Stimulation as a New Treatment for Refractory Spastic Cerebral Palsy</brief_title>
  <acronym>Andreani1</acronym>
  <official_title>Lateral Cord Electrical Stimulation Can Improve Spasticity in Chronic Spastic Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Juan Carlos M. Andreani MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundación CENIT</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sociedad Argenttina de Neuromodulación</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS)&#xD;
      causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing&#xD;
      spasticity and the spastic syndrome in selected cases of patients with cerebral palsy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PROJECT Lateral Cord Stimulation was thought by the author to be employed in patients with&#xD;
      spastic cerebral palsy with the aim to improve tonus, motor function and speech.&#xD;
&#xD;
      Nevertheless, as it has been demonstrated as acting on the basic phenomena related with&#xD;
      spasticity, it's to say the propagated spinal responses, its use could be extended to other&#xD;
      forms of spastic disease, like spastic limbs post stroke, brain congenital malformations&#xD;
      producing spasticity and motor disorders as the main signs, post anoxic encephalopathy, etc.&#xD;
&#xD;
      In this preliminary clinical trial, classed as phase 3, our sample must be very limited to&#xD;
      assure stable conditions for statistical significance, hence our group is going to be&#xD;
      circumscribed to certain conditions and pathology.&#xD;
&#xD;
      In the future, as long the method could spread its use, the extension on indications in other&#xD;
      pathological conditions is advisable thus, its possibilities of marketing could be enlarged&#xD;
      with its use in a broader spectrum of spastic patients.&#xD;
&#xD;
      Calculated risks are similar to those related with the ancient surgical technique called&#xD;
      &quot;Scoville&quot;technique, currently employed time ago for cervical discectomy (6) Investigational&#xD;
      plan The purpose of this clinical trial is to release spasticity and by this means improve&#xD;
      the condition of patients with spastic cerebral palsy by extradural lateral cord electrical&#xD;
      stimulation, by using currently employed electrodes and neurostimulators Those devices are&#xD;
      already FDA approved and currently used for Dorsal Column Stimulation with the objective to&#xD;
      treat chronic Pain and spasticity (Spasmodic Torticollis).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2024</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2026</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ashworth Scale</measure>
    <time_frame>Day 0 baseline evaluation. One post operative evaluation every 30 day during six months</time_frame>
    <description>The Ashworth scale has 5 points, they are: 1) no increase in muscle tone; 2) slight increase giving a catch when part is moved in flexion or extension; 3) more marked increase in tone but only after part is easily flexed; 4) considerable increase in tone; and 5) passive movement is difficult and affected part is rigid in flexion or extension</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Barthel Index</measure>
    <time_frame>Day 0 baseline evaluation. One post operative evaluation every 30 day during six months</time_frame>
    <description>The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility of the patient. The items include feeding, moving from wheelchair,etc, and the whole evaluation is from 100 maximum what means total independence, to 0, absolute dependence</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Functional Independence Measure (FIM)- for speech</measure>
    <time_frame>Day 0 baseline evaluation. One post operative evaluation every 30 day during six months</time_frame>
    <description>It is global independence assessment. In this case, we are going to take only those related to speech for disartria´s evaluation</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Spasticity</condition>
  <arm_group>
    <arm_group_label>Spasticity, Cerebral Palsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To perform a Lateral spinal cord surgical implant of electrodes for electrical neuromodulation of a cohort of selectyed patients with refractory Spastic Cerebral Palsy To compare spasticity and speech trouble´s evolution on a cohort of treated patients, by evaluating their pre and post operative status into one year follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lateral spinal cord surgical implant of electrodes</intervention_name>
    <description>The procedure is based on the classic approaches to posterior cervical region for herniated discs, actually not longer employed for that aim A unilateral hemilaminectomy will be performed at C3-C4 level, starting from 4th cervical spinous process.&#xD;
A multicontact electrode will be placed on the lateral surface of the spinal cord that will be subcutaneusly connected to an implanted pulse generator (IPG).</description>
    <arm_group_label>Spasticity, Cerebral Palsy</arm_group_label>
    <other_name>Implant of Neurostimulators (electrical generators)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged sixteen or older&#xD;
&#xD;
          -  Spastic Cerebral Palsy with stable condition&#xD;
&#xD;
          -  Motor disability unilateral or predominantly unilateral.&#xD;
&#xD;
          -  Troubles of speech clinically evident.&#xD;
&#xD;
          -  Normal or Slightly sub-normal I.Q&#xD;
&#xD;
          -  No psychiatric disorders.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cardiac or respiratory troubles&#xD;
&#xD;
          -  Fixed abnormal postures (except if previously corrected by orthopedic surgery)&#xD;
&#xD;
          -  Chronic recurrent bronchial or pulmonary infections&#xD;
&#xD;
          -  Chronic recurrent urinary infections&#xD;
&#xD;
          -  Severe osteoporosis on affected limbs&#xD;
&#xD;
          -  Chronic skin ulcerations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Carlos Andreani, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sociedad Argentina de Neuromodulación</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Werner Braunsdorf, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik von Magdeburg - Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juan Carlos Andreani, MD</last_name>
    <phone>5491150531392</phone>
    <email>jcmandreani@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Provincial Program of Neuromodulation</name>
      <address>
        <city>La Plata</city>
        <state>Buenos Aires</state>
        <zip>1045</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikummagdeburg</name>
      <address>
        <city>Magdeburg</city>
        <zip>399130</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Andreani JC, Guma C. New animal model to mimic spastic cerebral palsy: the brain-damaged pig preparation. Neuromodulation. 2008 Jul;11(3):196-201. doi: 10.1111/j.1525-1403.2008.00166.x.</citation>
    <PMID>22151096</PMID>
  </reference>
  <reference>
    <citation>Andreani JC, Guma C. Lateral cord stimulation decreases spastic electromyographic spreading: responses in a brain-damaged pig preparation. Neuromodulation. 2008 Jul;11(3):202-7. doi: 10.1111/j.1525-1403.2008.00167.x.</citation>
    <PMID>22151097</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>October 27, 2022</last_update_submitted>
  <last_update_submitted_qc>October 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sociedad Argenttina de Neuromodulación</investigator_affiliation>
    <investigator_full_name>Juan Carlos M. Andreani MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Dysarthria</keyword>
  <keyword>Electrical Stimulation</keyword>
  <keyword>Lateral Cord Stimulation</keyword>
  <keyword>Spasticity</keyword>
  <keyword>Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Yes, we plan to share data as long as participants are recruited. Because there are not yet patients, we do not have data to share</ipd_description>
  </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/NCT02199015
org study id: Andreani, JCM 1
nct id: NCT02199015
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The aim of our work is to investigate whether electrical Lateral Cord Stimulation (LCS)
      causes an inhibitory and modulatory action by indirect cerebellar activation, so releasing
      spasticity and the spastic syndrome in selected cases of patients with cerebral palsy
PROJECT Lateral Cord Stimulation was thought by the author to be employed in patients with
      spastic cerebral palsy with the aim to improve tonus, motor function and speech.

      Nevertheless, as it has been demonstrated as acting on the basic phenomena related with
      spasticity, it's to say the propagated spinal responses, its use could be extended to other
      forms of spastic disease, like spastic limbs post stroke, brain congenital malformations
      producing spasticity and motor disorders as the main signs, post anoxic encephalopathy, etc.

      In this preliminary clinical trial, classed as phase 3, our sample must be very limited to
      assure stable conditions for statistical significance, hence our group is going to be
      circumscribed to certain conditions and pathology.

      In the future, as long the method could spread its use, the extension on indications in other
      pathological conditions is advisable thus, its possibilities of marketing could be enlarged
      with its use in a broader spectrum of spastic patients.

      Calculated risks are similar to those related with the ancient surgical technique called
      "Scoville"technique, currently employed time ago for cervical discectomy (6) Investigational
      plan The purpose of this clinical trial is to release spasticity and by this means improve
      the condition of patients with spastic cerebral palsy by extradural lateral cord electrical
      stimulation, by using currently employed electrodes and neurostimulators Those devices are
      already FDA approved and currently used for Dorsal Column Stimulation with the objective to
      treat chronic Pain and spasticity (Spasmodic Torticollis).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ashworth Scale
time frame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
description: The Ashworth scale has 5 points, they are: 1) no increase in muscle tone; 2) slight increase giving a catch when part is moved in flexion or extension; 3) more marked increase in tone but only after part is easily flexed; 4) considerable increase in tone; and 5) passive movement is difficult and affected part is rigid in flexion or extension
measure: Barthel Index
time frame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
description: The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility of the patient. The items include feeding, moving from wheelchair,etc, and the whole evaluation is from 100 maximum what means total independence, to 0, absolute dependence
measure: Functional Independence Measure (FIM)- for speech
time frame: Day 0 baseline evaluation. One post operative evaluation every 30 day during six months
description: It is global independence assessment. In this case, we are going to take only those related to speech for disartria´s evaluation
arm group label: Spasticity, Cerebral Palsy
arm group type: Experimental
description: To perform a Lateral spinal cord surgical implant of electrodes for electrical neuromodulation of a cohort of selectyed patients with refractory Spastic Cerebral Palsy To compare spasticity and speech trouble´s evolution on a cohort of treated patients, by evaluating their pre and post operative status into one year follow up.
intervention type: Device
intervention name: Lateral spinal cord surgical implant of electrodes
description: The procedure is based on the classic approaches to posterior cervical region for herniated discs, actually not longer employed for that aim A unilateral hemilaminectomy will be performed at C3-C4 level, starting from 4th cervical spinous process.
A multicontact electrode will be placed on the lateral surface of the spinal cord that will be subcutaneusly connected to an implanted pulse generator (IPG).
arm group label: Spasticity, Cerebral Palsy
other name: Implant of Neurostimulators (electrical generators)
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Juan Carlos Andreani, MD
role: Study Director
affiliation: Sociedad Argentina de Neuromodulación
last name: Werner Braunsdorf, MD
role: Principal Investigator
affiliation: Klinik von Magdeburg - Germany
last name: Juan Carlos Andreani, MD
phone: 5491150531392
email: jcmandreani@gmail.com
facility: 
facility: 
country: Argentina
country: Germany
citation: Andreani JC, Guma C. New animal model to mimic spastic cerebral palsy: the brain-damaged pig preparation. Neuromodulation. 2008 Jul;11(3):196-201. doi: 10.1111/j.1525-1403.2008.00166.x.
PMID: 22151096
citation: Andreani JC, Guma C. Lateral cord stimulation decreases spastic electromyographic spreading: responses in a brain-damaged pig preparation. Neuromodulation. 2008 Jul;11(3):202-7. doi: 10.1111/j.1525-1403.2008.00167.x.
PMID: 22151097
responsible party type: Sponsor-Investigator
investigator affiliation: Sociedad Argenttina de Neuromodulación
investigator full name: Juan Carlos M. Andreani MD
investigator title: MD
mesh term: Muscle Spasticity
mesh term: Cerebral Palsy
sharing ipd: Yes
ipd description: Yes, we plan to share data as long as participants are recruited. Because there are not yet patients, we do not have data to share