xml: <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/NCT05973929</url>
    </required_header>
    <id_info>
      <org_study_id>Neuro-Med._0000044</org_study_id>
      <nct_id>NCT05973929</nct_id>
    </id_info>
    <brief_title>Movement Disorders in Multiple Sclerosis Patients</brief_title>
    <official_title>Clinical and Radiological Evaluation of Movement Disorders in Multiple Sclerosis Patients.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Azhar University</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>
        The aim of this study is to determine the prevalence of movement disorders in MS patients.&#xD;
  &#xD;
        Also,To know the clinical type of movement disorders occurring with multiple sclerosis&#xD;
        patients and the MRI finding of those patients. Moreover, to find the correlation between the&#xD;
        movement disorder and the different types of MS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients&#xD;
        who were diagnosed according to McDonald criteria of MS 2017 (Thompson et al. 2018).&#xD;
  &#xD;
        The investigators will study the prevalence of movement disorders in M.S patients, clinical&#xD;
        type of movement disorder and the MRI findings. Data collected from patients admitted or&#xD;
        following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The&#xD;
        included eligible patients should fulfil the following inclusion criteria:&#xD;
  &#xD;
        i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history&#xD;
        according to MS unit history sheet. iii. Detailed history of movement disorder which include&#xD;
        clinical type of movement disorder and medication taken (or not).&#xD;
  &#xD;
        iv. MRI Brain and spine of the included patient will be photographed.&#xD;
  &#xD;
        Exclusion criteria:&#xD;
  &#xD;
          1. Patients with multiple sclerosis mimics which can cause movement disorders e.g.,&#xD;
             systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic&#xD;
             failure, renal failure, hyperthyroidism, electrolyte disturbances, Behcet's disease or&#xD;
             CNS infection.&#xD;
  &#xD;
          2. patients with primary movement disorders or related to other neurodegenerative diseases.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 22, 2022</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 21, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Determine the prevalence of movement disorders in MS patients.</measure>
      <time_frame>Through study completion, an average of 1.5 year</time_frame>
      <description>To know the percentage of occurance of movement disorders in MS patients.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients.</measure>
      <time_frame>Through study completion, an average of 1.5 year</time_frame>
      <description>To know the specific semiology for each movement disorder.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>find the correlation between the movement disorder and the different types of MS.</measure>
      <time_frame>Through study completion, an average of 1.5 year</time_frame>
      <description>To know if there is a correlation between the movement disorder and the different types of MS.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">57</enrollment>
    <condition>Multiple Sclerosis</condition>
    <condition>Movement Disorders</condition>
    <arm_group>
      <arm_group_label>Multiple sclerosis patients with movement disorders.</arm_group_label>
      <description>A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to McDonald criteria of MS 2017 (Thompson et al. 2018).&#xD;
  We will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria:&#xD;
  i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not).&#xD;
  iv. MRI Brain and spine of the included patient will be photographed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Screen for movement disorder and correlates it with MRI findings.</intervention_name>
      <description>To determine the prevalence of movement disorders in MS patients.&#xD;
  To know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients.&#xD;
  To find the correlation between the movement disorder and the different types of MS.</description>
      <arm_group_label>Multiple sclerosis patients with movement disorders.</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis&#xD;
          patients who were diagnosed according to McDonald criteria of MS 2017.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - We will study the prevalence of movement disorders in M.S patients, clinical type of&#xD;
          movement disorder and the MRI findings. Data collected from patients admitted or following&#xD;
          at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included&#xD;
          eligible patients should fulfil the following inclusion criteria: i. Full clinical history&#xD;
          and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit&#xD;
          history sheet. iii. Detailed history of movement disorder which include clinical type of&#xD;
          movement disorder and medication taken (or not).&#xD;
  &#xD;
          iv. MRI Brain and spine of the included patient will be photographed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - 1-Patients with multiple sclerosis mimics which can cause movement disorders e.g.,&#xD;
          systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic&#xD;
          failure, renal failure, hyperthyroidism, electrolyte disturbances, Behcet's disease or CNS&#xD;
          infection.&#xD;
  &#xD;
          2-patients with primary movement disorders or related to other neurodegenerative diseases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Mostafa Mahmoud Hassan Meshref</name>
        <address>
          <city>Cairo</city>
          <state>Select A State Or Province</state>
          <zip>11571</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mostafa Meshref</last_name>
        <phone>+201557061988</phone>
        <email>mostafameshref1988@gmail.com</email>
      </contact>
      <contact_backup>
        <email>mostafameshref1988@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <results_reference>
      <citation>Abboud H, Yu XX, Knusel K, Fernandez HH, Cohen JA. Movement disorders in early MS and related diseases: A prospective observational study. Neurol Clin Pract. 2019 Feb;9(1):24-31. doi: 10.1212/CPJ.0000000000000560.</citation>
      <PMID>30859004</PMID>
    </results_reference>
    <results_reference>
      <citation>Calabresi PA. Diagnosis and management of multiple sclerosis. Am Fam Physician. 2004 Nov 15;70(10):1935-44.</citation>
      <PMID>15571060</PMID>
    </results_reference>
    <results_reference>
      <citation>Cameron MH, Nilsagard Y. Balance, gait, and falls in multiple sclerosis. Handb Clin Neurol. 2018;159:237-250. doi: 10.1016/B978-0-444-63916-5.00015-X.</citation>
      <PMID>30482317</PMID>
    </results_reference>
    <results_reference>
      <citation>Dendrou CA, Fugger L, Friese MA. Immunopathology of multiple sclerosis. Nat Rev Immunol. 2015 Sep 15;15(9):545-58. doi: 10.1038/nri3871. Epub 2015 Aug 7.</citation>
      <PMID>26250739</PMID>
    </results_reference>
    <results_reference>
      <citation>Deuschl G. Movement disorders in multiple sclerosis and their treatment. Neurodegener Dis Manag. 2016 Dec;6(6s):31-35. doi: 10.2217/nmt-2016-0053.</citation>
      <PMID>27874491</PMID>
    </results_reference>
    <results_reference>
      <citation>Fragoso YD, Araujo MG, Branco NL. Kinesigenic paroxysmal hemidyskinesia as the initial presentation of multiple sclerosis. MedGenMed. 2006 Oct 4;8(4):3.</citation>
      <PMID>17415286</PMID>
    </results_reference>
    <results_reference>
      <citation>Kobelt G, Thompson A, Berg J, Gannedahl M, Eriksson J; MSCOI Study Group; European Multiple Sclerosis Platform. New insights into the burden and costs of multiple sclerosis in Europe. Mult Scler. 2017 Jul;23(8):1123-1136. doi: 10.1177/1352458517694432. Epub 2017 Feb 1.</citation>
      <PMID>28273775</PMID>
    </results_reference>
    <results_reference>
      <citation>Mehanna R, Jankovic J. Movement disorders in multiple sclerosis and other demyelinating diseases. J Neurol Sci. 2013 May 15;328(1-2):1-8. doi: 10.1016/j.jns.2013.02.007. Epub 2013 Mar 19.</citation>
      <PMID>23522528</PMID>
    </results_reference>
    <results_reference>
      <citation>Nociti V, Bentivoglio AR, Frisullo G, Fasano A, Soleti F, Iorio R, Loria G, Patanella AK, Marti A, Tartaglione T, Tonali PA, Batocchi AP. Movement disorders in multiple sclerosis: Causal or coincidental association? Mult Scler. 2008 Nov;14(9):1284-7. doi: 10.1177/1352458508094883. Epub 2008 Sep 3.</citation>
      <PMID>18768580</PMID>
    </results_reference>
    <results_reference>
      <citation>Oakes PK, Srivatsal SR, Davis MY, Samii A. Movement disorders in multiple sclerosis. Phys Med Rehabil Clin N Am. 2013 Nov;24(4):639-51. doi: 10.1016/j.pmr.2013.06.003. Epub 2013 Aug 27.</citation>
      <PMID>24314682</PMID>
    </results_reference>
    <results_reference>
      <citation>Suarez-Cedeno G, Mehanna R. Movement Disorders in Multiple Sclerosis and Other Demyelinating Diseases: A Retrospective Review From a Tertiary Academic Center. Neurologist. 2021 Sep 7;26(5):161-166. doi: 10.1097/NRL.0000000000000333.</citation>
      <PMID>34491930</PMID>
    </results_reference>
    <results_reference>
      <citation>Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.</citation>
      <PMID>29275977</PMID>
    </results_reference>
    <results_reference>
      <citation>GBD 2016 Multiple Sclerosis Collaborators. Global, regional, and national burden of multiple sclerosis 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Mar;18(3):269-285. doi: 10.1016/S1474-4422(18)30443-5. Epub 2019 Jan 21.</citation>
      <PMID>30679040</PMID>
    </results_reference>
    <results_reference>
      <citation>Waubant E, Alize P, Tourbah A, Agid Y. Paroxysmal dystonia (tonic spasm) in multiple sclerosis. Neurology. 2001 Dec 26;57(12):2320-1. doi: 10.1212/wnl.57.12.2320. No abstract available.</citation>
      <PMID>11756623</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Azhar University</investigator_affiliation>
      <investigator_full_name>Mostafa Mahmoud Hassan Meshref</investigator_full_name>
      <investigator_title>Neurology physician</investigator_title>
    </responsible_party>
    <keyword>Multiple sclerosis</keyword>
    <keyword>Movement Disorders</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Movement Disorders</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05973929
  org study id: Neuro-Med._0000044
  nct id: NCT05973929
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to determine the prevalence of movement disorders in MS patients.
  
        Also,To know the clinical type of movement disorders occurring with multiple sclerosis
        patients and the MRI finding of those patients. Moreover, to find the correlation between the
        movement disorder and the different types of MS.
  A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients
        who were diagnosed according to McDonald criteria of MS 2017 (Thompson et al. 2018).
  
        The investigators will study the prevalence of movement disorders in M.S patients, clinical
        type of movement disorder and the MRI findings. Data collected from patients admitted or
        following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The
        included eligible patients should fulfil the following inclusion criteria:
  
        i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history
        according to MS unit history sheet. iii. Detailed history of movement disorder which include
        clinical type of movement disorder and medication taken (or not).
  
        iv. MRI Brain and spine of the included patient will be photographed.
  
        Exclusion criteria:
  
          1. Patients with multiple sclerosis mimics which can cause movement disorders e.g.,
             systemic disease or overlap syndromes including systemic lupus, vasculitis, hepatic
             failure, renal failure, hyperthyroidism, electrolyte disturbances, Behcet's disease or
             CNS infection.
  
          2. patients with primary movement disorders or related to other neurodegenerative diseases.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Determine the prevalence of movement disorders in MS patients.
  time frame: Through study completion, an average of 1.5 year
  description: To know the percentage of occurance of movement disorders in MS patients.
  measure: know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients.
  time frame: Through study completion, an average of 1.5 year
  description: To know the specific semiology for each movement disorder.
  measure: find the correlation between the movement disorder and the different types of MS.
  time frame: Through study completion, an average of 1.5 year
  description: To know if there is a correlation between the movement disorder and the different types of MS.
  arm group label: Multiple sclerosis patients with movement disorders.
  description: A randomized cross-sectional study will be conducted on diagnosed multiple sclerosis patients who were diagnosed according to McDonald criteria of MS 2017 (Thompson et al. 2018).
  We will study the prevalence of movement disorders in M.S patients, clinical type of movement disorder and the MRI findings. Data collected from patients admitted or following at Al-Azhar university hospitals at Al-Hussein and El-Sayed Galal hospitals. The included eligible patients should fulfil the following inclusion criteria:
  i. Full clinical history and neurological assessment. ii. Detailed multiple sclerosis history according to MS unit history sheet. iii. Detailed history of movement disorder which include clinical type of movement disorder and medication taken (or not).
  iv. MRI Brain and spine of the included patient will be photographed.
  intervention type: Other
  intervention name: Screen for movement disorder and correlates it with MRI findings.
  description: To determine the prevalence of movement disorders in MS patients.
  To know the clinical type of movement disorders occurring with multiple sclerosis patients and the MRI finding of those patients.
  To find the correlation between the movement disorder and the different types of MS.
  arm group label: Multiple sclerosis patients with movement disorders.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  citation: Abboud H, Yu XX, Knusel K, Fernandez HH, Cohen JA. Movement disorders in early MS and related diseases: A prospective observational study. Neurol Clin Pract. 2019 Feb;9(1):24-31. doi: 10.1212/CPJ.0000000000000560.
  PMID: 30859004
  citation: Calabresi PA. Diagnosis and management of multiple sclerosis. Am Fam Physician. 2004 Nov 15;70(10):1935-44.
  PMID: 15571060
  citation: Cameron MH, Nilsagard Y. Balance, gait, and falls in multiple sclerosis. Handb Clin Neurol. 2018;159:237-250. doi: 10.1016/B978-0-444-63916-5.00015-X.
  PMID: 30482317
  citation: Dendrou CA, Fugger L, Friese MA. Immunopathology of multiple sclerosis. Nat Rev Immunol. 2015 Sep 15;15(9):545-58. doi: 10.1038/nri3871. Epub 2015 Aug 7.
  PMID: 26250739
  citation: Deuschl G. Movement disorders in multiple sclerosis and their treatment. Neurodegener Dis Manag. 2016 Dec;6(6s):31-35. doi: 10.2217/nmt-2016-0053.
  PMID: 27874491
  citation: Fragoso YD, Araujo MG, Branco NL. Kinesigenic paroxysmal hemidyskinesia as the initial presentation of multiple sclerosis. MedGenMed. 2006 Oct 4;8(4):3.
  PMID: 17415286
  citation: Kobelt G, Thompson A, Berg J, Gannedahl M, Eriksson J; MSCOI Study Group; European Multiple Sclerosis Platform. New insights into the burden and costs of multiple sclerosis in Europe. Mult Scler. 2017 Jul;23(8):1123-1136. doi: 10.1177/1352458517694432. Epub 2017 Feb 1.
  PMID: 28273775
  citation: Mehanna R, Jankovic J. Movement disorders in multiple sclerosis and other demyelinating diseases. J Neurol Sci. 2013 May 15;328(1-2):1-8. doi: 10.1016/j.jns.2013.02.007. Epub 2013 Mar 19.
  PMID: 23522528
  citation: Nociti V, Bentivoglio AR, Frisullo G, Fasano A, Soleti F, Iorio R, Loria G, Patanella AK, Marti A, Tartaglione T, Tonali PA, Batocchi AP. Movement disorders in multiple sclerosis: Causal or coincidental association? Mult Scler. 2008 Nov;14(9):1284-7. doi: 10.1177/1352458508094883. Epub 2008 Sep 3.
  PMID: 18768580
  citation: Oakes PK, Srivatsal SR, Davis MY, Samii A. Movement disorders in multiple sclerosis. Phys Med Rehabil Clin N Am. 2013 Nov;24(4):639-51. doi: 10.1016/j.pmr.2013.06.003. Epub 2013 Aug 27.
  PMID: 24314682
  citation: Suarez-Cedeno G, Mehanna R. Movement Disorders in Multiple Sclerosis and Other Demyelinating Diseases: A Retrospective Review From a Tertiary Academic Center. Neurologist. 2021 Sep 7;26(5):161-166. doi: 10.1097/NRL.0000000000000333.
  PMID: 34491930
  citation: Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
  PMID: 29275977
  citation: GBD 2016 Multiple Sclerosis Collaborators. Global, regional, and national burden of multiple sclerosis 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Mar;18(3):269-285. doi: 10.1016/S1474-4422(18)30443-5. Epub 2019 Jan 21.
  PMID: 30679040
  citation: Waubant E, Alize P, Tourbah A, Agid Y. Paroxysmal dystonia (tonic spasm) in multiple sclerosis. Neurology. 2001 Dec 26;57(12):2320-1. doi: 10.1212/wnl.57.12.2320. No abstract available.
  PMID: 11756623
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: Mostafa Mahmoud Hassan Meshref
  investigator title: Neurology physician
  mesh term: Multiple Sclerosis
  mesh term: Movement Disorders
  mesh term: Sclerosis
  sharing ipd: Undecided