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/NCT05966038</url>
    </required_header>
    <id_info>
      <org_study_id>2013P001670</org_study_id>
      <nct_id>NCT05966038</nct_id>
    </id_info>
    <brief_title>ALS/MND Natural History Study Data Repository</brief_title>
    <official_title>ALS/MND Natural History Study Data Repository</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Henry Ford Health System</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Northwestern University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Temple University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>St. Louis University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Florida</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Minnesota</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Virginia Commonwealth University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Fondazione Serena Onlus - Centro Clinico NeMO Milano</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Providence Health &amp; Services</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Massachusetts General Hospital</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>
        This is a data repository for multi-site multi-protocol clinic-based Natural History Study of&#xD;
        ALS and Other Motor Neuron Disorders (MND).&#xD;
  &#xD;
        All people living with ALS or other MNDs who attend clinics at the Study hospitals (sites)&#xD;
        are offered to participate in the Study.&#xD;
  &#xD;
        The Sites collect so-called Baseline information including demographics, disease history and&#xD;
        diagnosis, family history, etc. At each visit, the Sites also collect multiple&#xD;
        disease-specific outcome measures and events. The information is captured in NeuroBANK, a&#xD;
        patient-centric clinical research platform.&#xD;
  &#xD;
        The Sites have an option to choose to collect data into 20+ additional forms capturing&#xD;
        biomarkers and outcome measures. Captured data after its curation are anonymized (all&#xD;
        personal identifiers and dates are being removed), and the anonymized dataset is shared with&#xD;
        medical researchers via a non-exclusive revocable license.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Most people with ALS or MND who are seen clinically by the PI or PI designees at&#xD;
        participating sites will be recruited into this study. This well-established framework&#xD;
        provides an opportunity to offer to a large proportion of people with ALS/MND a chance to&#xD;
        participate in a clinical research project.&#xD;
  &#xD;
        Upon obtaining consent, the following is done:&#xD;
  &#xD;
        People with ALS/MND are assigned a Neurological Global Unique Identifier (NeuroGUID) and its&#xD;
        study-specific derivative, NeuroSTAmP, which is used to link this Study's information to&#xD;
        biological samples, images, and clinical data obtained from those individuals in this Study&#xD;
        and other studies/trials, in which these patients participate(d).&#xD;
  &#xD;
        The following information is captured in NeuroBANK platform:&#xD;
  &#xD;
        Baseline information&#xD;
  &#xD;
          -  Longitudinal clinical and phenotypical data from routine clinical visits&#xD;
  &#xD;
          -  Longitudinal clinical and historical phenotypical data transcribed from electronic&#xD;
             health records and notes&#xD;
  &#xD;
          -  Any other observational data that are of interest to the Investigator may be captured or&#xD;
             linked to information in NeuroBANK.&#xD;
  &#xD;
        Other Key Features&#xD;
  &#xD;
        The site should track numbers of patients who declined participation. The site should have a&#xD;
        mechanism in place to include an offer of participation to each patient in clinic (consenting&#xD;
        does not require immediate data entry) Regular Data Quality checks may be performed at the&#xD;
        site. Site personnel who intend to have access to NeuroBANK are trained and certified prior&#xD;
        to given access.&#xD;
  &#xD;
        Several registries, both cross-sectional and longitudinal, currently exist in ALS. NeuroBANK&#xD;
        is distinct from other current registries in that it is a patient-centered platform that is&#xD;
        designed to function as a data repository of patient data from clinical visits and multiple&#xD;
        clinical research projects as well as linking these data to biorepository for tissue,&#xD;
        imaging, and other biological information. This natural history study can act as a clinical&#xD;
        research framework that may link clinical and clinical research data from current and past&#xD;
        studies with biological specimens and image collections.&#xD;
  &#xD;
        With obtained consents, biological specimens may be collected with bar-coded labels&#xD;
        containing patient assigned study specific NeuroSTAmPs, printed from within NeuroBANK, and&#xD;
        scanned into NeuroBANK's virtual distributed BioRepository module. Imaging studies are&#xD;
        de-identified with NeuroSTAmPs and linked to clinical and phenotypical information.&#xD;
        Anonymized clinical data obtained through this protocol are available to other researchers.&#xD;
  &#xD;
        Study Population&#xD;
  &#xD;
        Individuals who are seen during their clinical care visits are asked to allow their data to&#xD;
        be uploaded and captured for clinical research. The NeuroBANK platform is located at and&#xD;
        managed by the Center for Innovation and Bioinformatics (CIB), Neurological Clinical Research&#xD;
        Institute (NCRI) of Massachusetts General Hospital (Boston, MA).&#xD;
  &#xD;
        Consent Process&#xD;
  &#xD;
        Every participant in the ALS clinic is approached to participate in this study. A signed&#xD;
        informed consent form is obtained before any data are recorded for study purposes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2015</start_date>
    <completion_date type="Anticipated">December 31, 2030</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2030</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>5 Years</target_duration>
    <primary_outcome>
      <measure>ALS Functional Rating Scale-Revised (ALSFRS-R)</measure>
      <time_frame>Every 3-4 months up to 5 years</time_frame>
      <description>The ALS Functional Rating Scale revised is a 12-item rating scale that measures the progression of disability in patients with ALS. The ALSFRS-r assesses patients' levels of self-sufficiency in areas of feeding, grooming, ambulation and communication. The higher the score, the earlier in the disease progression.&#xD;
  It consists of 12 questions with a maximum score of 48 points.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Slow Vital Capacity (SVC)</measure>
      <time_frame>Every 3-4 months up to 5 years</time_frame>
      <description>Slow vital capacity test normalized to age, sex, and height</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Survival</measure>
      <time_frame>Every 3-4 months up to 5 years</time_frame>
      <description>Patient survival or survival equivalent (time to ventilator or feeding tube). Survival equivalent is assessed during routine clinical visits, while mortality event may be reported when becomes known to the treating clinician..</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Vital Signs</measure>
      <time_frame>Every 3-4 months up to 5 years</time_frame>
      <description>Vital Signs (Weight, BP, HR). Both systolic and diastolic pressure are measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neurological Examination</measure>
      <time_frame>Through study completion, annually up to 5 years</time_frame>
      <description>Neurological exam that tests for abnormality various areas, from general assessment to coordination and cerebellar function, to sensation and reflexes, to cranial nerves and plantar</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>El Escorial Criteria</measure>
      <time_frame>Through study completion, annually up to 5 years</time_frame>
      <description>The El Escorial criteria are diagnostic criteria for ALS. They classify patients into categories of possible, probable, or definite ALS, based on signs of degeneration of upper and lower motor neurons in different body regions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Handheld Dynamometry</measure>
      <time_frame>Every 3-4 months up to 5 years</time_frame>
      <description>Handheld Dynamometry for quantitative strength testing of 18 muscles that is a reliable and reproducible measure of decline in ALS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Grip Strength Testing</measure>
      <time_frame>Every 3-4 months up to 5 years</time_frame>
      <description>Grip Strength Testing</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rasch Overall ALS Disability Scale (ROADS)</measure>
      <time_frame>Every 3-4 months up to 5 years</time_frame>
      <description>Rasch Overall ALS Disability Scale, the ROADS provides a normed total score on 28 items from 0-146 to capture overall disability level in a linearly-weighted manner, with lower scores indicating disease progression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5 Times Sit to Stand</measure>
      <time_frame>Every 3-4 months up to 5 years</time_frame>
      <description>5 Times Sit to Stand Test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>10 Meter Walk Test</measure>
      <time_frame>Every 3-4 months up to 5 years</time_frame>
      <description>10 Meter Walk Test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Examination</measure>
      <time_frame>Through study completion, annually up to 5 years</time_frame>
      <description>Physical Examination that includes the following test areas for abnormality and clinical significance: respiratory, cardio, gastrointestinal, genitourinary. and musculoskeletal</description>
    </secondary_outcome>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>ALS</condition>
    <condition>PLS</condition>
    <condition>MND (Motor Neurone DIsease)</condition>
    <condition>Kennedy Disease</condition>
    <condition>PMA - Progressive Muscular Atrophy</condition>
    <condition>PBP - Progressive Bulbar Palsy</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Participating sites may collect biofluids, including DNA, plasma, serum, etc.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          All people living with ALS/MND at participating multidisciplinary ALS/MND clinics&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A clinical diagnosis of El Escorial of suspected, possible, probable, or definite ALS&#xD;
               or&#xD;
  &#xD;
            -  Other motor neuron disorders, including but not limited to Spinal-Bulbar Muscular&#xD;
               Atrophy (SBMA, Kennedy's disease), Spinal Muscular Atrophy (SMA), Primary Lateral&#xD;
               Sclerosis (PLS), Progressive Muscular Atrophy (PMA), and Progressive Bulbar Palsy&#xD;
               (PBP)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Disease does not meet criteria for any motor neuron disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alexander Sherman</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Natalia Tarasenko</last_name>
      <phone>1617240346</phone>
      <email>ntarasenko@mgh.harvard.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Florida</name>
        <address>
          <city>Gainesville</city>
          <state>Florida</state>
          <zip>32610</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jennifer Steshyn</last_name>
        <email>Jennifer.Steshyn@neurology.ufl.edu</email>
      </contact>
      <investigator>
        <last_name>James Wymer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Northwestern University</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60611</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emma Schmidt</last_name>
        <phone>312-503-4362</phone>
        <email>emma.schmidt@northwestern.edu</email>
      </contact>
      <investigator>
        <last_name>Senda Ajroud-Driss</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Henry Ford Health System</name>
        <address>
          <city>Detroit</city>
          <state>Michigan</state>
          <zip>48202</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anne Vallis</last_name>
        <phone>313-916-1364</phone>
        <email>avallis1@hfhs.org</email>
      </contact>
      <investigator>
        <last_name>Ximena Arcila Londono</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Minnesota</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55455</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Valerie Ferment</last_name>
        <phone>612-301-1535</phone>
        <email>ferm0016@umn.edu</email>
      </contact>
      <investigator>
        <last_name>David Walk</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Saint Louis University</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Katie Forsman</last_name>
        <email>katie.forsman@health.slu.edu</email>
      </contact>
      <investigator>
        <last_name>Ghazala Hayat</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Providence ALS Clinic</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97213</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tyler Regan</last_name>
        <phone>503-215-2333</phone>
        <email>tyler.regan@providence.org</email>
      </contact>
      <investigator>
        <last_name>Nicholas Olney</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Temple University Lewis Katz School of Medicine</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19140</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>John Furey</last_name>
        <phone>267-694-0573</phone>
        <email>john.furey0001@temple.edu</email>
      </contact>
      <investigator>
        <last_name>Terry Heiman-Patterson</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Virginia Commonwealth University</name>
        <address>
          <city>Richmond</city>
          <state>Virginia</state>
          <zip>22908</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Demetrius Carter</last_name>
        <email>Demetrius.R.Carter@vcuhealth.org</email>
      </contact>
      <investigator>
        <last_name>Kelly Gwathmey</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centro Clinico NEMO Milano</name>
        <address>
          <city>Milan</city>
          <zip>20162</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Monica Montuori</last_name>
        <email>monica.montuori@centrocliniconemo.it</email>
      </contact>
      <investigator>
        <last_name>Federica Cerri</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Italy</country>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.data4cures.org/natural-history-consortium</url>
      <description>ALS/MND NATURAL HISTORY CONSORTIUM</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Alexander Sherman</investigator_full_name>
      <investigator_title>Director, Center for Innovation and Bioinformatics</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscular Atrophy</mesh_term>
      <mesh_term>Motor Neuron Disease</mesh_term>
      <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
      <mesh_term>Bulbo-Spinal Atrophy, X-Linked</mesh_term>
      <mesh_term>Muscular Atrophy, Spinal</mesh_term>
      <mesh_term>Bulbar Palsy, Progressive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Anonymized IPD are being shared with data requestors upon submission of the research proposal online. Data Access Committee reviews submissions and upon approval and execution of the Data Sharing Agreement, the dataset is provided to the data requestor.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>10-30 days from the initial request's online submission</ipd_time_frame>
      <ipd_access_criteria>ALS/MND Natural History Consortium's Data Access committee reviews the merits of the requestors' research proposals and approves or denies data access</ipd_access_criteria>
    </patient_data>
    <study_docs>
      <study_doc>
        <doc_id>NeuroGUID/NeuroSTAmP</doc_id>
        <doc_type>Individual Participant Data Set</doc_type>
        <doc_url>https://www.data4cures.org/requestingdata</doc_url>
        <doc_comment>Anonymized data may be requested by submitting research proposal online. Data Access Committee will review the submission and upon its approval and execution of the Data Sharing Agreement, the dataset will be provided to the data requestor.</doc_comment>
      </study_doc>
    </study_docs>
    <!-- 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/NCT05966038
  org study id: 2013P001670
  nct id: NCT05966038
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a data repository for multi-site multi-protocol clinic-based Natural History Study of
        ALS and Other Motor Neuron Disorders (MND).
  
        All people living with ALS or other MNDs who attend clinics at the Study hospitals (sites)
        are offered to participate in the Study.
  
        The Sites collect so-called Baseline information including demographics, disease history and
        diagnosis, family history, etc. At each visit, the Sites also collect multiple
        disease-specific outcome measures and events. The information is captured in NeuroBANK, a
        patient-centric clinical research platform.
  
        The Sites have an option to choose to collect data into 20+ additional forms capturing
        biomarkers and outcome measures. Captured data after its curation are anonymized (all
        personal identifiers and dates are being removed), and the anonymized dataset is shared with
        medical researchers via a non-exclusive revocable license.
  Most people with ALS or MND who are seen clinically by the PI or PI designees at
        participating sites will be recruited into this study. This well-established framework
        provides an opportunity to offer to a large proportion of people with ALS/MND a chance to
        participate in a clinical research project.
  
        Upon obtaining consent, the following is done:
  
        People with ALS/MND are assigned a Neurological Global Unique Identifier (NeuroGUID) and its
        study-specific derivative, NeuroSTAmP, which is used to link this Study's information to
        biological samples, images, and clinical data obtained from those individuals in this Study
        and other studies/trials, in which these patients participate(d).
  
        The following information is captured in NeuroBANK platform:
  
        Baseline information
  
          -  Longitudinal clinical and phenotypical data from routine clinical visits
  
          -  Longitudinal clinical and historical phenotypical data transcribed from electronic
             health records and notes
  
          -  Any other observational data that are of interest to the Investigator may be captured or
             linked to information in NeuroBANK.
  
        Other Key Features
  
        The site should track numbers of patients who declined participation. The site should have a
        mechanism in place to include an offer of participation to each patient in clinic (consenting
        does not require immediate data entry) Regular Data Quality checks may be performed at the
        site. Site personnel who intend to have access to NeuroBANK are trained and certified prior
        to given access.
  
        Several registries, both cross-sectional and longitudinal, currently exist in ALS. NeuroBANK
        is distinct from other current registries in that it is a patient-centered platform that is
        designed to function as a data repository of patient data from clinical visits and multiple
        clinical research projects as well as linking these data to biorepository for tissue,
        imaging, and other biological information. This natural history study can act as a clinical
        research framework that may link clinical and clinical research data from current and past
        studies with biological specimens and image collections.
  
        With obtained consents, biological specimens may be collected with bar-coded labels
        containing patient assigned study specific NeuroSTAmPs, printed from within NeuroBANK, and
        scanned into NeuroBANK's virtual distributed BioRepository module. Imaging studies are
        de-identified with NeuroSTAmPs and linked to clinical and phenotypical information.
        Anonymized clinical data obtained through this protocol are available to other researchers.
  
        Study Population
  
        Individuals who are seen during their clinical care visits are asked to allow their data to
        be uploaded and captured for clinical research. The NeuroBANK platform is located at and
        managed by the Center for Innovation and Bioinformatics (CIB), Neurological Clinical Research
        Institute (NCRI) of Massachusetts General Hospital (Boston, MA).
  
        Consent Process
  
        Every participant in the ALS clinic is approached to participate in this study. A signed
        informed consent form is obtained before any data are recorded for study purposes.
  observational model: Other
  time perspective: Prospective
  measure: ALS Functional Rating Scale-Revised (ALSFRS-R)
  time frame: Every 3-4 months up to 5 years
  description: The ALS Functional Rating Scale revised is a 12-item rating scale that measures the progression of disability in patients with ALS. The ALSFRS-r assesses patients' levels of self-sufficiency in areas of feeding, grooming, ambulation and communication. The higher the score, the earlier in the disease progression.
  It consists of 12 questions with a maximum score of 48 points.
  measure: Slow Vital Capacity (SVC)
  time frame: Every 3-4 months up to 5 years
  description: Slow vital capacity test normalized to age, sex, and height
  measure: Survival
  time frame: Every 3-4 months up to 5 years
  description: Patient survival or survival equivalent (time to ventilator or feeding tube). Survival equivalent is assessed during routine clinical visits, while mortality event may be reported when becomes known to the treating clinician..
  measure: Vital Signs
  time frame: Every 3-4 months up to 5 years
  description: Vital Signs (Weight, BP, HR). Both systolic and diastolic pressure are measured.
  measure: Neurological Examination
  time frame: Through study completion, annually up to 5 years
  description: Neurological exam that tests for abnormality various areas, from general assessment to coordination and cerebellar function, to sensation and reflexes, to cranial nerves and plantar
  measure: El Escorial Criteria
  time frame: Through study completion, annually up to 5 years
  description: The El Escorial criteria are diagnostic criteria for ALS. They classify patients into categories of possible, probable, or definite ALS, based on signs of degeneration of upper and lower motor neurons in different body regions.
  measure: Handheld Dynamometry
  time frame: Every 3-4 months up to 5 years
  description: Handheld Dynamometry for quantitative strength testing of 18 muscles that is a reliable and reproducible measure of decline in ALS
  measure: Grip Strength Testing
  time frame: Every 3-4 months up to 5 years
  description: Grip Strength Testing
  measure: Rasch Overall ALS Disability Scale (ROADS)
  time frame: Every 3-4 months up to 5 years
  description: Rasch Overall ALS Disability Scale, the ROADS provides a normed total score on 28 items from 0-146 to capture overall disability level in a linearly-weighted manner, with lower scores indicating disease progression
  measure: 5 Times Sit to Stand
  time frame: Every 3-4 months up to 5 years
  description: 5 Times Sit to Stand Test
  measure: 10 Meter Walk Test
  time frame: Every 3-4 months up to 5 years
  description: 10 Meter Walk Test
  measure: Physical Examination
  time frame: Through study completion, annually up to 5 years
  description: Physical Examination that includes the following test areas for abnormality and clinical significance: respiratory, cardio, gastrointestinal, genitourinary. and musculoskeletal
  Participating sites may collect biofluids, including DNA, plasma, serum, etc.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Alexander Sherman
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Natalia Tarasenko
  phone: 1617240346
  email: ntarasenko@mgh.harvard.edu
  facility: 
  status: Recruiting
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  country: Italy
  country: United States
  url: https://www.data4cures.org/natural-history-consortium
  description: ALS/MND NATURAL HISTORY CONSORTIUM
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Alexander Sherman
  investigator title: Director, Center for Innovation and Bioinformatics
  mesh term: Muscular Atrophy
  mesh term: Motor Neuron Disease
  mesh term: Amyotrophic Lateral Sclerosis
  mesh term: Bulbo-Spinal Atrophy, X-Linked
  mesh term: Muscular Atrophy, Spinal
  mesh term: Bulbar Palsy, Progressive
  sharing ipd: Yes
  ipd description: Anonymized IPD are being shared with data requestors upon submission of the research proposal online. Data Access Committee reviews submissions and upon approval and execution of the Data Sharing Agreement, the dataset is provided to the data requestor.
  ipd info type: Study Protocol
  ipd time frame: 10-30 days from the initial request's online submission
  ipd access criteria: ALS/MND Natural History Consortium's Data Access committee reviews the merits of the requestors' research proposals and approves or denies data access
  study doc: 