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/NCT06012110</url>
    </required_header>
    <id_info>
      <org_study_id>2023-219-NSU</org_study_id>
      <nct_id>NCT06012110</nct_id>
    </id_info>
    <brief_title>Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis</brief_title>
    <official_title>Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nova Southeastern University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nova Southeastern University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to determine if non-invasive electrical stimulation, using&#xD;
        an electric stimulator placed on the skin of the patients back and abdomen for 30 minutes can&#xD;
        reduce muscle spasms (spasticity) and improve walking function in patients with primary&#xD;
        lateral sclerosis. Participants will attend one in-person clinic visit and participate in one&#xD;
        telephone interview 24 hours after the treatment. The clinic visit will include&#xD;
        pre-intervention, treatment and post-intervention assessments. The assessments will consist&#xD;
        of a complete physical exam by the clinic neurologist followed by assessments and scoring of&#xD;
        spasticity, deep tendon reflexes, gait quality, gait speed, gait endurance and balance.&#xD;
        Patient's will rate their perceived spasticity pre, immediately post and 24 hours post&#xD;
        treatment.&#xD;
  &#xD;
        The treatment involves one 30-minute electrical stimulation session, which includes&#xD;
        application of electrode pads to the patients back and abdomen. The patient will lay supine&#xD;
        (on their back) with a pillow placed under their knees for comfort. The pads will then be&#xD;
        connected to an FDA approved electrical stimulator. The electrical stimulator will be turned&#xD;
        on and current adjusted to the individual patient based on small muscle contractions in their&#xD;
        legs. Once the current is set, the patient will lay supine for 30 minutes. After 30 minutes,&#xD;
        the device will be turned off and electrode pads removed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: The primary aim of this preliminary pilot study is to assess the clinical effects&#xD;
        of transcutaneous electrical stimulation (tES) in reducing spasticity in the lower&#xD;
        extremities and increasing mobility in patients with Primary Lateral Sclerosis (PLS).&#xD;
  &#xD;
        Study population: 6 patients with a confirmed diagnosis of PLS aged 18-90&#xD;
  &#xD;
        Design:&#xD;
  &#xD;
        Each enrolled participant will attend one in-person clinic visit and participate in one&#xD;
        telephone interview 24 hours post-treatment.&#xD;
  &#xD;
        The clinic visit will include pre-intervention, treatment and post-intervention assessments.&#xD;
        The assessments will consist of a complete physical exam by the clinic neurologist followed&#xD;
        by assessments and scoring of spasticity, deep tendon reflexes, gait quality, gait speed,&#xD;
        gait endurance and balance. The patients will rate their perceived spasticity pre,&#xD;
        immediately post and 24 hours post treatment.&#xD;
  &#xD;
        Treatment will include a 30-minute transcutaneous electrical stimulation (tES) session where&#xD;
        tES will be applied through two sets of electrodes positioned adjacent to the T11/T12 spinous&#xD;
        processes and a second pair of electrodes placed para-umbilically on the lower abdomen. A&#xD;
        current-controlled electrical stimulator will be used to deliver charge-balanced symmetrical,&#xD;
        biphasic rectangular pulses to the paraspinal electrodes as the anode for the first phase and&#xD;
        as the cathode for the second phase of the stimulation phase.&#xD;
  &#xD;
        Electrode placement will be verified by applying electrical stimulation to elicit mild&#xD;
        posterior root-muscle (PRM) contractions in the L2-S2 innervated rectus femoris, biceps&#xD;
        femoris, tibialis anterior, and triceps surae muscle group bilaterally with the participants&#xD;
        relaxed in the supine position. This will be determined by palpation at the patellar and&#xD;
        achilles tendons of both sides. While the participants remain supine, the stimulator will be&#xD;
        set to continuous mode to deliver stimulation at a frequency of 50 Hz and pulse width of 400&#xD;
        microseconds, then the stimulation amplitude will be slowly increased from 0 milliamp (mA) to&#xD;
        an amplitude that may generate minor paraesthesias (slight tingling sensations) in some&#xD;
        individuals in the bilateral L2-S2 lower extremity dermatomes but below the level that&#xD;
        elicited posterior motor root (PMR) contraction responses. The stimulation amplitude will be&#xD;
        individually assessed and set for each participant, and the stimulation amplitude upper limit&#xD;
        will be no more than 90% of the lowest PRM response for each participant. After this&#xD;
        30-minute tES session, the tES unit will be turned off, the electrodes removed, and the&#xD;
        participants assessed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Modified Ashworth Scale</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>6 category ordinal scale (minimum value = 0 maximum value = 4) that measures spasticity where higher scores indicate greater spasticity</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Deep Tendon Reflex Scale</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>5 point ordinal scale recorded as a number from 0-4 where 2 is normal and any number above or below this is abnormal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>10-meter walk test (10MWT)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The 10MWT measures gait speed where the time it takes patient to cover a distance of 6 meters is recorded in m/s.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6 minute walk test (6MWT)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The 6MWT assesses overall gait function and endurance. The total distance travelled in 6 minutes is recorded in feet.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tinetti Performance Oriented Mobility Assessment</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>3 point ordinal scale that ranges from 0-2 with a total possible score of 28 that measures gait quality and balance. Higher scores indicate improved gait and balance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>0-10 numeric rating scale</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Patients will self rate their spasticity on a scale of 0-10 with 0 = no spasticity and 10 = worst possible spasticity.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">6</enrollment>
    <condition>Primary Lateral Sclerosis</condition>
    <arm_group>
      <arm_group_label>Transcutaneous electrical stimulation to reduce spasticity in PLS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Primary lateral sclerosis (PLS) is a progressive upper motor neuron neurodegenerative disorder. A hallmark of PLS is a presentation with lower extremity stiffness and spasticity as well as bulbar involvement. The investigators will be performing a preliminary study designed to assess transcutaneous electrical stimulation (tES), a non-pharmacological and non-invasive modality used in spinal cord injury and multiple sclerosis patients, as a treatment for reducing spasticity in the lower extremities and increasing mobility in patients with PLS.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcutaneous electrical stimulation</intervention_name>
      <description>While participants are supine with a pillow placed below the knees for comfort, one 30-minute transcutaneous electrical stimulation session will be performed at a frequency of 50 Hz, pulse width of 400 microseconds and individualized amplitude will be completed.</description>
      <arm_group_label>Transcutaneous electrical stimulation to reduce spasticity in PLS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of primary lateral sclerosis by the treating neurologist&#xD;
  &#xD;
            -  Ambulatory with or without a assistive device or orthotic&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of cancer in the lumbar or thoracic spine&#xD;
  &#xD;
            -  History of surgery with hardware in the lumbar or thoracic spine&#xD;
  &#xD;
            -  Acute lower back pathology&#xD;
  &#xD;
            -  Current pregnancy&#xD;
  &#xD;
            -  History of implantable cardiac device&#xD;
  &#xD;
            -  Diagnosis of significant cognitive impairment by the treating physician&#xD;
  &#xD;
            -  History of seizures or diagnosis of epilepsy&#xD;
  &#xD;
            -  Open wound at location of electrodes&#xD;
  &#xD;
            -  Complete loss of sensation at the area of electrode placement&#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>Eduardo Locatelli, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nova Southeastern University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Alan Boruch, DO, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Northeast Regional Medical Center / A.T. Still University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kayla Chomko, DPT</last_name>
      <phone>954-262-6387</phone>
      <email>kchomko@nova.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lauren Tabor Gray, PhD</last_name>
      <email>Lauren.Taborgray@nova.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>NSU Health Neuroscience Institute</name>
        <address>
          <city>Davie</city>
          <state>Florida</state>
          <zip>33328</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nikole Lesmes-Rincon</last_name>
        <phone>954-262-6387</phone>
      </contact>
      <contact_backup>
        <last_name>Kayla Chomko, DPT</last_name>
        <email>kchomko@nova.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://compasshealthbrands.com/products?pSearch=intensity%20select%20combo%20II</url>
      <description>Link to electrical stimulator utilized in this study</description>
    </link>
    <reference>
      <citation>Feldman EL, Goutman SA, Petri S, Mazzini L, Savelieff MG, Shaw PJ, Sobue G. Amyotrophic lateral sclerosis. Lancet. 2022 Oct 15;400(10360):1363-1380. doi: 10.1016/S0140-6736(22)01272-7. Epub 2022 Sep 15.</citation>
      <PMID>36116464</PMID>
    </reference>
    <reference>
      <citation>Nashold BS Jr, Friedman H. Dorsal column stimulation for control of pain. Preliminary report on 30 patients. J Neurosurg. 1972 May;36(5):590-7. doi: 10.3171/jns.1972.36.5.0590. No abstract available.</citation>
      <PMID>5026545</PMID>
    </reference>
    <reference>
      <citation>Cook AW, Weinstein SP. Chronic dorsal column stimulation in multiple sclerosis. Preliminary report. N Y State J Med. 1973 Dec 15;73(24):2868-72. No abstract available.</citation>
      <PMID>4543587</PMID>
    </reference>
    <reference>
      <citation>Lin A, Shaaya E, Calvert JS, Parker SR, Borton DA, Fridley JS. A Review of Functional Restoration From Spinal Cord Stimulation in Patients With Spinal Cord Injury. Neurospine. 2022 Sep;19(3):703-734. doi: 10.14245/ns.2244652.326. Epub 2022 Sep 30.</citation>
      <PMID>36203296</PMID>
    </reference>
    <reference>
      <citation>Hofstoetter US, Freundl B, Danner SM, Krenn MJ, Mayr W, Binder H, Minassian K. Transcutaneous Spinal Cord Stimulation Induces Temporary Attenuation of Spasticity in Individuals with Spinal Cord Injury. J Neurotrauma. 2020 Feb 1;37(3):481-493. doi: 10.1089/neu.2019.6588. Epub 2019 Aug 9.</citation>
      <PMID>31333064</PMID>
    </reference>
    <reference>
      <citation>Hofstoetter US, Freundl B, Lackner P, Binder H. Transcutaneous Spinal Cord Stimulation Enhances Walking Performance and Reduces Spasticity in Individuals with Multiple Sclerosis. Brain Sci. 2021 Apr 8;11(4):472. doi: 10.3390/brainsci11040472.</citation>
      <PMID>33917893</PMID>
    </reference>
    <reference>
      <citation>Turner MR, Barohn RJ, Corcia P, Fink JK, Harms MB, Kiernan MC, Ravits J, Silani V, Simmons Z, Statland J, van den Berg LH; Delegates of the 2nd International PLS Conference; Mitsumoto H. Primary lateral sclerosis: consensus diagnostic criteria. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):373-377. doi: 10.1136/jnnp-2019-322541. Epub 2020 Feb 6.</citation>
      <PMID>32029539</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Motor Neuron Disease</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This study will provide pilot data to establish a larger, more robust study. The data will be kept internally.</ipd_description>
    </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/NCT06012110
  org study id: 2023-219-NSU
  nct id: NCT06012110
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The goal of this clinical trial is to determine if non-invasive electrical stimulation, using
        an electric stimulator placed on the skin of the patients back and abdomen for 30 minutes can
        reduce muscle spasms (spasticity) and improve walking function in patients with primary
        lateral sclerosis. Participants will attend one in-person clinic visit and participate in one
        telephone interview 24 hours after the treatment. The clinic visit will include
        pre-intervention, treatment and post-intervention assessments. The assessments will consist
        of a complete physical exam by the clinic neurologist followed by assessments and scoring of
        spasticity, deep tendon reflexes, gait quality, gait speed, gait endurance and balance.
        Patient's will rate their perceived spasticity pre, immediately post and 24 hours post
        treatment.
  
        The treatment involves one 30-minute electrical stimulation session, which includes
        application of electrode pads to the patients back and abdomen. The patient will lay supine
        (on their back) with a pillow placed under their knees for comfort. The pads will then be
        connected to an FDA approved electrical stimulator. The electrical stimulator will be turned
        on and current adjusted to the individual patient based on small muscle contractions in their
        legs. Once the current is set, the patient will lay supine for 30 minutes. After 30 minutes,
        the device will be turned off and electrode pads removed.
  Objective: The primary aim of this preliminary pilot study is to assess the clinical effects
        of transcutaneous electrical stimulation (tES) in reducing spasticity in the lower
        extremities and increasing mobility in patients with Primary Lateral Sclerosis (PLS).
  
        Study population: 6 patients with a confirmed diagnosis of PLS aged 18-90
  
        Design:
  
        Each enrolled participant will attend one in-person clinic visit and participate in one
        telephone interview 24 hours post-treatment.
  
        The clinic visit will include pre-intervention, treatment and post-intervention assessments.
        The assessments will consist of a complete physical exam by the clinic neurologist followed
        by assessments and scoring of spasticity, deep tendon reflexes, gait quality, gait speed,
        gait endurance and balance. The patients will rate their perceived spasticity pre,
        immediately post and 24 hours post treatment.
  
        Treatment will include a 30-minute transcutaneous electrical stimulation (tES) session where
        tES will be applied through two sets of electrodes positioned adjacent to the T11/T12 spinous
        processes and a second pair of electrodes placed para-umbilically on the lower abdomen. A
        current-controlled electrical stimulator will be used to deliver charge-balanced symmetrical,
        biphasic rectangular pulses to the paraspinal electrodes as the anode for the first phase and
        as the cathode for the second phase of the stimulation phase.
  
        Electrode placement will be verified by applying electrical stimulation to elicit mild
        posterior root-muscle (PRM) contractions in the L2-S2 innervated rectus femoris, biceps
        femoris, tibialis anterior, and triceps surae muscle group bilaterally with the participants
        relaxed in the supine position. This will be determined by palpation at the patellar and
        achilles tendons of both sides. While the participants remain supine, the stimulator will be
        set to continuous mode to deliver stimulation at a frequency of 50 Hz and pulse width of 400
        microseconds, then the stimulation amplitude will be slowly increased from 0 milliamp (mA) to
        an amplitude that may generate minor paraesthesias (slight tingling sensations) in some
        individuals in the bilateral L2-S2 lower extremity dermatomes but below the level that
        elicited posterior motor root (PMR) contraction responses. The stimulation amplitude will be
        individually assessed and set for each participant, and the stimulation amplitude upper limit
        will be no more than 90% of the lowest PRM response for each participant. After this
        30-minute tES session, the tES unit will be turned off, the electrodes removed, and the
        participants assessed.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Modified Ashworth Scale
  time frame: through study completion, an average of 1 year
  description: 6 category ordinal scale (minimum value = 0 maximum value = 4) that measures spasticity where higher scores indicate greater spasticity
  measure: Deep Tendon Reflex Scale
  time frame: through study completion, an average of 1 year
  description: 5 point ordinal scale recorded as a number from 0-4 where 2 is normal and any number above or below this is abnormal.
  measure: 10-meter walk test (10MWT)
  time frame: through study completion, an average of 1 year
  description: The 10MWT measures gait speed where the time it takes patient to cover a distance of 6 meters is recorded in m/s.
  measure: 6 minute walk test (6MWT)
  time frame: through study completion, an average of 1 year
  description: The 6MWT assesses overall gait function and endurance. The total distance travelled in 6 minutes is recorded in feet.
  measure: Tinetti Performance Oriented Mobility Assessment
  time frame: through study completion, an average of 1 year
  description: 3 point ordinal scale that ranges from 0-2 with a total possible score of 28 that measures gait quality and balance. Higher scores indicate improved gait and balance.
  measure: 0-10 numeric rating scale
  time frame: through study completion, an average of 1 year
  description: Patients will self rate their spasticity on a scale of 0-10 with 0 = no spasticity and 10 = worst possible spasticity.
  arm group label: Transcutaneous electrical stimulation to reduce spasticity in PLS
  arm group type: Experimental
  description: Primary lateral sclerosis (PLS) is a progressive upper motor neuron neurodegenerative disorder. A hallmark of PLS is a presentation with lower extremity stiffness and spasticity as well as bulbar involvement. The investigators will be performing a preliminary study designed to assess transcutaneous electrical stimulation (tES), a non-pharmacological and non-invasive modality used in spinal cord injury and multiple sclerosis patients, as a treatment for reducing spasticity in the lower extremities and increasing mobility in patients with PLS.
  intervention type: Device
  intervention name: Transcutaneous electrical stimulation
  description: While participants are supine with a pillow placed below the knees for comfort, one 30-minute transcutaneous electrical stimulation session will be performed at a frequency of 50 Hz, pulse width of 400 microseconds and individualized amplitude will be completed.
  arm group label: Transcutaneous electrical stimulation to reduce spasticity in PLS
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Eduardo Locatelli, MD, MPH
  role: Principal Investigator
  affiliation: Nova Southeastern University
  last name: Alan Boruch, DO, PhD
  role: Principal Investigator
  affiliation: Northeast Regional Medical Center / A.T. Still University
  last name: Kayla Chomko, DPT
  phone: 954-262-6387
  email: kchomko@nova.edu
  last name: Lauren Tabor Gray, PhD
  email: Lauren.Taborgray@nova.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  url: https://compasshealthbrands.com/products?pSearch=intensity%20select%20combo%20II
  description: Link to electrical stimulator utilized in this study
  citation: Feldman EL, Goutman SA, Petri S, Mazzini L, Savelieff MG, Shaw PJ, Sobue G. Amyotrophic lateral sclerosis. Lancet. 2022 Oct 15;400(10360):1363-1380. doi: 10.1016/S0140-6736(22)01272-7. Epub 2022 Sep 15.
  PMID: 36116464
  citation: Nashold BS Jr, Friedman H. Dorsal column stimulation for control of pain. Preliminary report on 30 patients. J Neurosurg. 1972 May;36(5):590-7. doi: 10.3171/jns.1972.36.5.0590. No abstract available.
  PMID: 5026545
  citation: Cook AW, Weinstein SP. Chronic dorsal column stimulation in multiple sclerosis. Preliminary report. N Y State J Med. 1973 Dec 15;73(24):2868-72. No abstract available.
  PMID: 4543587
  citation: Lin A, Shaaya E, Calvert JS, Parker SR, Borton DA, Fridley JS. A Review of Functional Restoration From Spinal Cord Stimulation in Patients With Spinal Cord Injury. Neurospine. 2022 Sep;19(3):703-734. doi: 10.14245/ns.2244652.326. Epub 2022 Sep 30.
  PMID: 36203296
  citation: Hofstoetter US, Freundl B, Danner SM, Krenn MJ, Mayr W, Binder H, Minassian K. Transcutaneous Spinal Cord Stimulation Induces Temporary Attenuation of Spasticity in Individuals with Spinal Cord Injury. J Neurotrauma. 2020 Feb 1;37(3):481-493. doi: 10.1089/neu.2019.6588. Epub 2019 Aug 9.
  PMID: 31333064
  citation: Hofstoetter US, Freundl B, Lackner P, Binder H. Transcutaneous Spinal Cord Stimulation Enhances Walking Performance and Reduces Spasticity in Individuals with Multiple Sclerosis. Brain Sci. 2021 Apr 8;11(4):472. doi: 10.3390/brainsci11040472.
  PMID: 33917893
  citation: Turner MR, Barohn RJ, Corcia P, Fink JK, Harms MB, Kiernan MC, Ravits J, Silani V, Simmons Z, Statland J, van den Berg LH; Delegates of the 2nd International PLS Conference; Mitsumoto H. Primary lateral sclerosis: consensus diagnostic criteria. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):373-377. doi: 10.1136/jnnp-2019-322541. Epub 2020 Feb 6.
  PMID: 32029539
  responsible party type: Sponsor
  mesh term: Motor Neuron Disease
  mesh term: Sclerosis
  sharing ipd: No
  ipd description: This study will provide pilot data to establish a larger, more robust study. The data will be kept internally.