<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/NCT02226432</url>
  </required_header>
  <id_info>
    <org_study_id>Andreani, JCM 2</org_study_id>
    <nct_id>NCT02226432</nct_id>
  </id_info>
  <brief_title>Combined Antagonistic Muscle Magnetic Stimulation and Selective Periferal Neurotomy to Improve Results on Spasticity</brief_title>
  <acronym>Andreani2</acronym>
  <official_title>The Use of Antagonistic Muscle Magnetic Stimulation to Avoid Extensive Lesions and Improve Results of Selective Peripheral Neurotomy on Refractory and I POost Stroke Spasticity With Exclusive or Predominant Right Upper Limb Arm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Juan Carlos M. Andreani MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sociedad Argenttina de Neuromodulación</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 objective of the present trial is to demonstrate Magnetic stimulation as an useful&#xD;
      complementary treatment in order to improve patients' evolution without the need of extensive&#xD;
      surgical lesion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with refractory post stroke upper right limb spasticity will operated by Median&#xD;
      nerve or Median/ Cubital selective neurotomy depending upon more affected territories.&#xD;
&#xD;
      Some of them could be also also operated with posterioris tibialis neurotomy to treat&#xD;
      equine's foot whenever also clinically present. Preoperative motor blocks might be possitive&#xD;
      in all cases.&#xD;
&#xD;
      A week later, they will be treated by magnetic stimulation on selected antagonistic muscles,&#xD;
      related to pre - operative affected ones, mostly deltoids, triceps and finger extensors with&#xD;
      an equipment Dipol Zeta D5 (Russian Federation), with 1.5 tesla of intensity.&#xD;
&#xD;
      Trials will be repeated twice a week in sessions of 30 minutes during 6 months with&#xD;
      simultaneous intensive classic rehabilitation.&#xD;
&#xD;
      Patients will be monthly evaluated by the mean score of Modified Ashworth Scale, related to&#xD;
      fingers, wrist, elbow and shoulder and also with Barthel Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">May 2024</start_date>
  <completion_date type="Anticipated">March 2026</completion_date>
  <primary_completion_date type="Anticipated">August 2025</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Ashworth Scale (MAS)</measure>
    <time_frame>Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months.</time_frame>
    <description>- Mean Preoperative and sequencial monthly postoperative evaluation of stiffness and ranges of joint pasive movements at the shoulder, elbow, wrist and fingers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl - Meyer Scale</measure>
    <time_frame>Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months.</time_frame>
    <description>Pre and post operative evaluation of a set of active and pasive movements and articular angles in the upper limb</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barthel Scale</measure>
    <time_frame>Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.</time_frame>
    <description>Pre and post operative evaluation of ten basic current dayly life activities, scored 10, 5 or 0 points each one, a total of 100 points</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>STROKE</condition>
  <arm_group>
    <arm_group_label>Kinesics</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>- Classic Rehabilitation and Kinesic Therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>surgery</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>- Surgery:&#xD;
Selective Peripheral Neurotomy is surgical a method of section on suplying peripheral nerves of motor fascicles to relieve harmful spasticity. An intraoperative stimulation of motor fascicles is done, and those which abnormal spreading on far placed myotomes are more evident are chosen to be sectioned.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Magnetic Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>- Postoperative Antagonistic Peripheral Magnetic Stimulation with 1.5 tesla intensity, infrathreshold 80 per cent of minimal intensity able to produce always muscle contraccion. Trials repeated twice a week in sessions of 30 minutes during 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>- Postoperative Antagonistic Peripheral Magnetic Stimulation</intervention_name>
    <description>Selected patients will be treated with Selective peripheral Neurotomy followed by an standartized cycle of Selective Peripheral Magnetic Stimulation and classic post operative Kinesic Therapy.&#xD;
Sham patients (n 10) will be treated with classic post operative Kinesic Therapy.&#xD;
Comparision of both groups will be statistified</description>
    <arm_group_label>Kinesics</arm_group_label>
    <arm_group_label>Magnetic Stimulation</arm_group_label>
    <arm_group_label>surgery</arm_group_label>
    <other_name>- Preoperative Peripheral Nerve Blockade</other_name>
    <other_name>- Selective Peripheral Neurotomy</other_name>
    <other_name>- Kinesic Rehabilitation Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Selective Peripheral Magnetic Stimulation</intervention_name>
    <description>Peripheral 1.5 tesla intensity, 10 Hz of Frequency, with &quot;eight saped&quot; bovine, of 30 minutes, aplied on antagonistic muscles, twice a week. Intensity will be infrathreshold, 80 per cent of the individual threshold (minimal amount of intensity producing always a muscle motor response in each particular patient)</description>
    <arm_group_label>Magnetic Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesics</intervention_name>
    <description>Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.</description>
    <arm_group_label>Kinesics</arm_group_label>
    <arm_group_label>Magnetic Stimulation</arm_group_label>
    <arm_group_label>surgery</arm_group_label>
    <other_name>Classic Rehabilitation Treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe and refractory right Hemiparesia or Hemiplegia, affecting hand function.&#xD;
&#xD;
          -  Failure of kinesic treatment&#xD;
&#xD;
          -  2 points or more Improvement on Modified Ashworth Scale after anestethic blockade&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe cardiovascular disease&#xD;
&#xD;
          -  Severe pulmonary disease&#xD;
&#xD;
          -  Neoplasia advanced disease&#xD;
&#xD;
          -  Joint anchylosis&#xD;
&#xD;
          -  Irreversible retraction for muscle fibrosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Carlos Mario Andreani, MD</last_name>
    <role>Study Director</role>
    <affiliation>Fundación CENIT</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fabián César Piedimonte, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación CENIT - President</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juan Carlos Mario Andreani, MD</last_name>
    <phone>91150531392</phone>
    <email>jcmandreani@gmail.com</email>
  </overall_contact>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>June 17, 2023</last_update_submitted>
  <last_update_submitted_qc>June 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</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>Barthel Scale</keyword>
  <keyword>Disability</keyword>
  <keyword>Modified Ashworth Scale</keyword>
  <keyword>Right Arm</keyword>
  <keyword>Neuromodulation</keyword>
  <keyword>Spasticity</keyword>
  <keyword>Stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
    <mesh_term>Stroke</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/NCT02226432
org study id: Andreani, JCM 2
nct id: NCT02226432
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the present trial is to demonstrate Magnetic stimulation as an useful
      complementary treatment in order to improve patients' evolution without the need of extensive
      surgical lesion.
Patients with refractory post stroke upper right limb spasticity will operated by Median
      nerve or Median/ Cubital selective neurotomy depending upon more affected territories.

      Some of them could be also also operated with posterioris tibialis neurotomy to treat
      equine's foot whenever also clinically present. Preoperative motor blocks might be possitive
      in all cases.

      A week later, they will be treated by magnetic stimulation on selected antagonistic muscles,
      related to pre - operative affected ones, mostly deltoids, triceps and finger extensors with
      an equipment Dipol Zeta D5 (Russian Federation), with 1.5 tesla of intensity.

      Trials will be repeated twice a week in sessions of 30 minutes during 6 months with
      simultaneous intensive classic rehabilitation.

      Patients will be monthly evaluated by the mean score of Modified Ashworth Scale, related to
      fingers, wrist, elbow and shoulder and also with Barthel Scale.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Modified Ashworth Scale (MAS)
time frame: Post operative Modified Ashworth Scale /MAS) setted up monthly for each patient taking into account the postoperative date, during six continued months.
description: - Mean Preoperative and sequencial monthly postoperative evaluation of stiffness and ranges of joint pasive movements at the shoulder, elbow, wrist and fingers.
measure: Fugl - Meyer Scale
time frame: Post operative Fugl - Meyer Scale evaluation, setted up monthly for each patient taking into account the postoperative date, during six continued months.
description: Pre and post operative evaluation of a set of active and pasive movements and articular angles in the upper limb
measure: Barthel Scale
time frame: Post operative Barthel Scale evaluation setted up monthly for each patient taking into account the postoperative date, during six continued months.
description: Pre and post operative evaluation of ten basic current dayly life activities, scored 10, 5 or 0 points each one, a total of 100 points
arm group label: Kinesics
arm group type: Sham Comparator
description: - Classic Rehabilitation and Kinesic Therapy
arm group label: surgery
arm group type: Sham Comparator
description: - Surgery:
Selective Peripheral Neurotomy is surgical a method of section on suplying peripheral nerves of motor fascicles to relieve harmful spasticity. An intraoperative stimulation of motor fascicles is done, and those which abnormal spreading on far placed myotomes are more evident are chosen to be sectioned.
arm group label: Magnetic Stimulation
arm group type: Active Comparator
description: - Postoperative Antagonistic Peripheral Magnetic Stimulation with 1.5 tesla intensity, infrathreshold 80 per cent of minimal intensity able to produce always muscle contraccion. Trials repeated twice a week in sessions of 30 minutes during 6 months
intervention type: Procedure
intervention name: - Postoperative Antagonistic Peripheral Magnetic Stimulation
description: Selected patients will be treated with Selective peripheral Neurotomy followed by an standartized cycle of Selective Peripheral Magnetic Stimulation and classic post operative Kinesic Therapy.
Sham patients (n 10) will be treated with classic post operative Kinesic Therapy.
Comparision of both groups will be statistified
arm group label: Kinesics
arm group label: Magnetic Stimulation
arm group label: surgery
other name: - Preoperative Peripheral Nerve Blockade
other name: - Selective Peripheral Neurotomy
other name: - Kinesic Rehabilitation Therapy
intervention type: Device
intervention name: Selective Peripheral Magnetic Stimulation
description: Peripheral 1.5 tesla intensity, 10 Hz of Frequency, with "eight saped" bovine, of 30 minutes, aplied on antagonistic muscles, twice a week. Intensity will be infrathreshold, 80 per cent of the individual threshold (minimal amount of intensity producing always a muscle motor response in each particular patient)
arm group label: Magnetic Stimulation
intervention type: Other
intervention name: Kinesics
description: Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.
arm group label: Kinesics
arm group label: Magnetic Stimulation
arm group label: surgery
other name: Classic Rehabilitation Treatment
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
last name: Juan Carlos Mario Andreani, MD
role: Study Director
affiliation: Fundación CENIT
last name: Fabián César Piedimonte, MD
role: Principal Investigator
affiliation: Fundación CENIT - President
last name: Juan Carlos Mario Andreani, MD
phone: 91150531392
email: jcmandreani@gmail.com
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: Stroke
sharing ipd: No