<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/NCT04474977</url>
  </required_header>
  <id_info>
    <org_study_id>Hemifacial Spasm</org_study_id>
    <nct_id>NCT04474977</nct_id>
  </id_info>
  <brief_title>Microvascular Decompressive Surgery for Hemifacial Spasm</brief_title>
  <official_title>Microvascular Decompressive Surgery for Hemifacial Spasm: Nuances of Technique and Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      -  Review the clinical outcomes of Micro vascular decompression of Hemi facial Spasm.&#xD;
&#xD;
        -  Assess safety and efficacy of Micro vascular decompression.&#xD;
&#xD;
        -  Improve the outcome of these patients and decease rate of recurrence and complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hemi facial spasm (HFS), a term described in 1905 by Babinski but first reported by Schultz&#xD;
      in 1875, is a highly morbid movement disorder characterized by intermittent involuntary&#xD;
      movement of muscles innervated by the facial nerve.&#xD;
&#xD;
      (HFS) affects roughly 10 in 100,000 individuals in fifth or sixth decades of life.&#xD;
&#xD;
      Primary HFS is commonly attributed to vascular loops compressing the seventh cranial nerve at&#xD;
      its exit zone from the brainstem. The facial nerve compression is thought to lead to ephaptic&#xD;
      transmission and to hyperactivity of the facial nucleus, resulting in the involuntary facial&#xD;
      movements.&#xD;
&#xD;
      Secondary HFS frequently follows peripheral facial palsy or may arise from facial nerve&#xD;
      damage produced by tumours, demyelinating disorders, traumatisms, and infections accounting&#xD;
      for 1-2 &amp; of HFS.&#xD;
&#xD;
      Over four in five primary HFS cases involve either anterior or posterior inferior cerebellar&#xD;
      artery as the primary offender although vertebral artery, multiple vessels and veins may be&#xD;
      involved.&#xD;
&#xD;
      EMG recordings confirm the diagnosis by showing a typical electrophysiological signature:&#xD;
      clonic facial muscle contractions, hyperactivity, and synkinesis, lateral spread evoked&#xD;
      responses.&#xD;
&#xD;
      Imaging can be useful for confirming that HFS is primary in nature and due to a neurovascular&#xD;
      compression. In most cases (95% of the patients) the compressive vessel, generally an artery,&#xD;
      is seen on MRI combined with MR-Angiography (MRA). High resolution T2-sequence is to be used&#xD;
      to get good delineation of the facial nerve.&#xD;
&#xD;
      Many treatments for HFS have been reported, including pharmacological agents, botulinum toxin&#xD;
      injection, facial nerve blockage, physical therapy, radiofrequency ablation, acupuncture, as&#xD;
      well as facial nerve combing and microvascular decompression (MVD).&#xD;
&#xD;
      However, while MVD is effective, there are still significant postoperative complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Samsung Medical center Grading system for Severity of Hemifacial Spasm</measure>
    <time_frame>one month</time_frame>
    <description>Success rate by assessing the degree of hemifacial spasm pre and post-operative using the SMC grading system proposed by Lee et all</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hearing Affection</measure>
    <time_frame>one month</time_frame>
    <description>Audiometry: to detect the degree of post-operative hearing affection using WHO Grading system For Hearing Loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrence</measure>
    <time_frame>Six Month</time_frame>
    <description>Recurrence rate within the duration of follow up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morbidity and mortality</measure>
    <time_frame>Six Month</time_frame>
    <description>Morbidity and mortality rates related to the procedure using modified Rankin Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in facial evoked EMG</measure>
    <time_frame>one month</time_frame>
    <description>Detect the changes in facial evoked EMG preoperative and postoperative and its correlation to outcomes (esp. disappearance of lateral spread response)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Hemifacial Spasm</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Microvascular Decompressive Surgery</intervention_name>
    <description>Microvascular decompression for hemifacial spasm</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The sample size calculated by sample size calculator software according to:&#xD;
&#xD;
          1. confidence interval : 95%&#xD;
&#xD;
          2. power : 80%&#xD;
&#xD;
          3. P-value : 5%&#xD;
&#xD;
          4. Prevalence : 0.79/100000&#xD;
&#xD;
          5. Population size: 110,000 referenced by Assiut health directory statistics 2018 All&#xD;
             cases that fulfil the selection criteria that will be admitted in the department of&#xD;
             neurosurgery at Assiut university hospital with expected size of at least 30 patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Primary Hemi facial spasm Unilateral Adults 20-60 years Clinical Diagnosis confirmed by&#xD;
        Facial Evoked potential &amp; Neuroimaging&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Secondary Hemi facial spasm caused by intracranial masses or other lesions Recurrent Hemi&#xD;
        facial spasm Patients who are unfit for any neurosurgical interventions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>THUREL R. [Peripheral facial hemispasm, trigeminal neuralgia and masticatory spasm on the same side]. Rev Neurol (Paris). 1951;85(4):288-9. No abstract available. Undetermined Language.</citation>
    <PMID>14921388</PMID>
  </reference>
  <reference>
    <citation>Wu Y, Davidson AL, Pan T, Jankovic J. Asian over-representation among patients with hemifacial spasm compared to patients with cranial-cervical dystonia. J Neurol Sci. 2010 Nov 15;298(1-2):61-3. doi: 10.1016/j.jns.2010.08.017.</citation>
    <PMID>20864122</PMID>
  </reference>
  <reference>
    <citation>Auger RG. Hemifacial spasm: clinical and electrophysiologic observations. Neurology. 1979 Sep;29(9 Pt 1):1261-72. doi: 10.1212/wnl.29.9_part_1.1261.</citation>
    <PMID>573406</PMID>
  </reference>
  <reference>
    <citation>Cui Z, Ling Z. Advances in microvascular decompression for hemifacial spasm. J Otol. 2015 Mar;10(1):1-6. doi: 10.1016/j.joto.2015.06.002. Epub 2015 Jul 26.</citation>
    <PMID>29937774</PMID>
  </reference>
  <reference>
    <citation>Hyun SJ, Kong DS, Park K. Microvascular decompression for treating hemifacial spasm: lessons learned from a prospective study of 1,174 operations. Neurosurg Rev. 2010 Jul;33(3):325-34; discussion 334. doi: 10.1007/s10143-010-0254-9. Epub 2010 Mar 27.</citation>
    <PMID>20349099</PMID>
  </reference>
  <results_reference>
    <citation>Sindou M, Mercier P. Microvascular decompression for hemifacial spasm: Outcome on spasm and complications. A review. Neurochirurgie. 2018 May;64(2):106-116. doi: 10.1016/j.neuchi.2018.01.001. Epub 2018 Feb 15.</citation>
    <PMID>29454467</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Zanaty</investigator_full_name>
    <investigator_title>Asisstant Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemifacial Spasm</mesh_term>
    <mesh_term>Spasm</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/NCT04474977
org study id: Hemifacial Spasm
nct id: NCT04474977
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
-  Review the clinical outcomes of Micro vascular decompression of Hemi facial Spasm.

        -  Assess safety and efficacy of Micro vascular decompression.

        -  Improve the outcome of these patients and decease rate of recurrence and complications.
Hemi facial spasm (HFS), a term described in 1905 by Babinski but first reported by Schultz
      in 1875, is a highly morbid movement disorder characterized by intermittent involuntary
      movement of muscles innervated by the facial nerve.

      (HFS) affects roughly 10 in 100,000 individuals in fifth or sixth decades of life.

      Primary HFS is commonly attributed to vascular loops compressing the seventh cranial nerve at
      its exit zone from the brainstem. The facial nerve compression is thought to lead to ephaptic
      transmission and to hyperactivity of the facial nucleus, resulting in the involuntary facial
      movements.

      Secondary HFS frequently follows peripheral facial palsy or may arise from facial nerve
      damage produced by tumours, demyelinating disorders, traumatisms, and infections accounting
      for 1-2 & of HFS.

      Over four in five primary HFS cases involve either anterior or posterior inferior cerebellar
      artery as the primary offender although vertebral artery, multiple vessels and veins may be
      involved.

      EMG recordings confirm the diagnosis by showing a typical electrophysiological signature:
      clonic facial muscle contractions, hyperactivity, and synkinesis, lateral spread evoked
      responses.

      Imaging can be useful for confirming that HFS is primary in nature and due to a neurovascular
      compression. In most cases (95% of the patients) the compressive vessel, generally an artery,
      is seen on MRI combined with MR-Angiography (MRA). High resolution T2-sequence is to be used
      to get good delineation of the facial nerve.

      Many treatments for HFS have been reported, including pharmacological agents, botulinum toxin
      injection, facial nerve blockage, physical therapy, radiofrequency ablation, acupuncture, as
      well as facial nerve combing and microvascular decompression (MVD).

      However, while MVD is effective, there are still significant postoperative complications.
observational model: Case-Only
time perspective: Prospective
measure: Samsung Medical center Grading system for Severity of Hemifacial Spasm
time frame: one month
description: Success rate by assessing the degree of hemifacial spasm pre and post-operative using the SMC grading system proposed by Lee et all
measure: Hearing Affection
time frame: one month
description: Audiometry: to detect the degree of post-operative hearing affection using WHO Grading system For Hearing Loss
measure: Recurrence
time frame: Six Month
description: Recurrence rate within the duration of follow up
measure: Morbidity and mortality
time frame: Six Month
description: Morbidity and mortality rates related to the procedure using modified Rankin Scale
measure: changes in facial evoked EMG
time frame: one month
description: Detect the changes in facial evoked EMG preoperative and postoperative and its correlation to outcomes (esp. disappearance of lateral spread response)
intervention type: Other
intervention name: Microvascular Decompressive Surgery
description: Microvascular decompression for hemifacial spasm
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
citation: THUREL R. [Peripheral facial hemispasm, trigeminal neuralgia and masticatory spasm on the same side]. Rev Neurol (Paris). 1951;85(4):288-9. No abstract available. Undetermined Language.
PMID: 14921388
citation: Wu Y, Davidson AL, Pan T, Jankovic J. Asian over-representation among patients with hemifacial spasm compared to patients with cranial-cervical dystonia. J Neurol Sci. 2010 Nov 15;298(1-2):61-3. doi: 10.1016/j.jns.2010.08.017.
PMID: 20864122
citation: Auger RG. Hemifacial spasm: clinical and electrophysiologic observations. Neurology. 1979 Sep;29(9 Pt 1):1261-72. doi: 10.1212/wnl.29.9_part_1.1261.
PMID: 573406
citation: Cui Z, Ling Z. Advances in microvascular decompression for hemifacial spasm. J Otol. 2015 Mar;10(1):1-6. doi: 10.1016/j.joto.2015.06.002. Epub 2015 Jul 26.
PMID: 29937774
citation: Hyun SJ, Kong DS, Park K. Microvascular decompression for treating hemifacial spasm: lessons learned from a prospective study of 1,174 operations. Neurosurg Rev. 2010 Jul;33(3):325-34; discussion 334. doi: 10.1007/s10143-010-0254-9. Epub 2010 Mar 27.
PMID: 20349099
citation: Sindou M, Mercier P. Microvascular decompression for hemifacial spasm: Outcome on spasm and complications. A review. Neurochirurgie. 2018 May;64(2):106-116. doi: 10.1016/j.neuchi.2018.01.001. Epub 2018 Feb 15.
PMID: 29454467
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Zanaty
investigator title: Asisstant Lecturer
mesh term: Hemifacial Spasm
mesh term: Spasm
sharing ipd: No