<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/NCT03300856</url>
  </required_header>
  <id_info>
    <org_study_id>999917170</org_study_id>
    <secondary_id>17-N-N170</secondary_id>
    <nct_id>NCT03300856</nct_id>
  </id_info>
  <brief_title>Chart Review: Central Motor Conduction Time in Neurological Disorders</brief_title>
  <official_title>Chart Review: Central Motor Conduction Time in Neurological Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Background:&#xD;
&#xD;
      TMS stands for transcranial magnetic stimulation. It is a non-invasive way to stimulate the&#xD;
      brain. It helps researchers study the nervous system. TMS can assess central motor conduction&#xD;
      time (CMCT). That can be used to diagnose some diseases. It can also show how well treatments&#xD;
      are working. Researchers want to study the records of people who have already had TMS. They&#xD;
      want to see how it relates to the results of diagnostic studies.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To study the results of transcranial magnetic stimulation in certain neurological disorders.&#xD;
      To create a descriptive analysis of the results.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Records that are already in the NINDS database&#xD;
&#xD;
      Design:&#xD;
&#xD;
      The study will not enroll any participants.&#xD;
&#xD;
      Researchers will search the database for certain terms. These include TMS, CMTC, and motor&#xD;
      evoked potentials. This will identify records of people who had TMS for diagnosis.&#xD;
&#xD;
      Using data from the records, researchers will calculate CMCT. They will note other data that&#xD;
      relate to CMCT.&#xD;
&#xD;
      Researchers will analyze their findings. They will write a review article.&#xD;
&#xD;
      Personal data will be removed from all the records before the findings are analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective- To retrospectively study the results of transcranial magnetic stimulation (TMS) in&#xD;
      various neurological disorders and create a descriptive analysis of the results.&#xD;
&#xD;
      Study population- Existing records of patients within the NINDS database who have had TMS&#xD;
      performed to measure central motor conduction time (CMCT).&#xD;
&#xD;
      Design-&#xD;
&#xD;
        -  Retrospective descriptive analysis.&#xD;
&#xD;
        -  The NINDS EMG Database will be queried using terms such as TMS, CMCT, and MEP (motor&#xD;
           evoked potentials) to identify EMG reports on patients who underwent TMS for diagnosis&#xD;
&#xD;
        -  Within these reports peripheral motor conduction time (PMCT), the cortical motor evoked&#xD;
           potential (MEP) latency and amplitude will be used to calculate CMCT, clinical patient&#xD;
           factors pertinent to estimation of CMCT as well clinically significant physical exam&#xD;
           findings will be recorded as well.&#xD;
&#xD;
        -  Clinical diagnoses and neurological exams will be extracted from medical records&#xD;
&#xD;
        -  Patient identifiers will be de-linked after compiling data from medical records&#xD;
&#xD;
      Outcome measures&#xD;
&#xD;
      - Results of CMCT using TMS in different diagnoses will be summarized for different&#xD;
      neurologic disorders and correlated to clinical exam measures documented in previous records&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Actual">July 19, 2018</completion_date>
  <primary_completion_date type="Actual">July 19, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Summary of central motor conduction studies in neurological disorders</measure>
    <time_frame>Study completion</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">225</enrollment>
  <condition>Neurological Disorder</condition>
  <arm_group>
    <arm_group_label>Chart Review</arm_group_label>
    <description>Existing records of patients within the NINDS database who have had TMS performed to measure central motor conduction time (CMCT).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Existing records of patients within the NINDS database who have had TMS performed to&#xD;
        measure central motor conduction time (CMCT).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
               1. Patients who were seen in the NINDS EMG section for diagnostic TMS studies&#xD;
&#xD;
               2. Patients tested between 1998 and 2017&#xD;
&#xD;
               3. Greater than or equal to age 18.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Kay Floeter, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Neurological Disorders and Stroke (NINDS)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Neurological Disorders and Stroke (NINDS)</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transcranial Magnetic Stimulation (TMS)</keyword>
  <keyword>Electrophysiology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03300856
org study id: 999917170
secondary id: 17-N-N170
nct id: NCT03300856
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      TMS stands for transcranial magnetic stimulation. It is a non-invasive way to stimulate the
      brain. It helps researchers study the nervous system. TMS can assess central motor conduction
      time (CMCT). That can be used to diagnose some diseases. It can also show how well treatments
      are working. Researchers want to study the records of people who have already had TMS. They
      want to see how it relates to the results of diagnostic studies.

      Objectives:

      To study the results of transcranial magnetic stimulation in certain neurological disorders.
      To create a descriptive analysis of the results.

      Eligibility:

      Records that are already in the NINDS database

      Design:

      The study will not enroll any participants.

      Researchers will search the database for certain terms. These include TMS, CMTC, and motor
      evoked potentials. This will identify records of people who had TMS for diagnosis.

      Using data from the records, researchers will calculate CMCT. They will note other data that
      relate to CMCT.

      Researchers will analyze their findings. They will write a review article.

      Personal data will be removed from all the records before the findings are analyzed.
Objective- To retrospectively study the results of transcranial magnetic stimulation (TMS) in
      various neurological disorders and create a descriptive analysis of the results.

      Study population- Existing records of patients within the NINDS database who have had TMS
      performed to measure central motor conduction time (CMCT).

      Design-

        -  Retrospective descriptive analysis.

        -  The NINDS EMG Database will be queried using terms such as TMS, CMCT, and MEP (motor
           evoked potentials) to identify EMG reports on patients who underwent TMS for diagnosis

        -  Within these reports peripheral motor conduction time (PMCT), the cortical motor evoked
           potential (MEP) latency and amplitude will be used to calculate CMCT, clinical patient
           factors pertinent to estimation of CMCT as well clinically significant physical exam
           findings will be recorded as well.

        -  Clinical diagnoses and neurological exams will be extracted from medical records

        -  Patient identifiers will be de-linked after compiling data from medical records

      Outcome measures

      - Results of CMCT using TMS in different diagnoses will be summarized for different
      neurologic disorders and correlated to clinical exam measures documented in previous records
observational model: Other
time perspective: Retrospective
measure: Summary of central motor conduction studies in neurological disorders
time frame: Study completion
arm group label: Chart Review
description: Existing records of patients within the NINDS database who have had TMS performed to measure central motor conduction time (CMCT).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
last name: Mary Kay Floeter, M.D.
role: Principal Investigator
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nervous System Diseases