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/NCT06012357</url>
    </required_header>
    <id_info>
      <org_study_id>CE/PROG.603</org_study_id>
      <nct_id>NCT06012357</nct_id>
    </id_info>
    <brief_title>Pain Protocol: Nociception Coma Scale-Revised With Personalized Stimulus</brief_title>
    <official_title>Nociception Coma Scale-Revised Recorded After Personalized Stimulus May Improve Assessment of Pain Responses in Non-communicative Patients With Disorders of Consciousness. An International Multicentric Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>I.R.C.C.S. Fondazione Santa Lucia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>I.R.C.C.S. Fondazione Santa Lucia</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 goal of this observational study is to compare Nociception Coma Scale-Revised Recorded&#xD;
        (NCS-R) scores obtained with the standard pressure on fingernail bed (standard stimulus, SS)&#xD;
        versus other personalized painful stimuli (PS), in non-communicative patients with disorders&#xD;
        of consciousness (DoC), as indicated by professionals and caregivers involved in their care&#xD;
        and rehabilitation. The study aims also to establish possible correlations between NCS-R and&#xD;
        Coma Recovery Scale-Revised (CRS-R.) The main question : an integrated patient-centered&#xD;
        approach for assessment of the physical pain, in which clinical measures and behavioral&#xD;
        observations will be integrated, to understand and manage the pain intensity, may improve&#xD;
        treatment and rehabilitation outcome. Specifically, a new version of NCS-R, adapted with PS,&#xD;
        may produce more intentional and specific responses to pain-inducing maneuvers. Investigating&#xD;
        pain perception in non-communicative patients, through recognition of a personalized source&#xD;
        of nociception and pain, may avoid non specific, useless and harmful noxious tests (as with&#xD;
        standard pain scales) and may provide tools for revealing nociception even in the lack of any&#xD;
        response to standard clinical evaluation.&#xD;
  &#xD;
        Question 1: the superiority of personalized painful stimulus a standard painful stimulation&#xD;
        in nin communicative patients.&#xD;
  &#xD;
        Question 2: the parallel recovery of painful stimuli responsiveness and consciousness&#xD;
        Participants will Responsiveness and pain perception will be assessed respectively with the&#xD;
        CRS-R and the NCS-R. Pain responses will be assessed by means of standard stimulus (NCS-R-SS,&#xD;
        as used in the CRS-R) and personalized stimulation (NCS-R-PS), at admission and discharge.&#xD;
  &#xD;
        CRS-R will be administered within the first month after admission, at least 5 times in&#xD;
        different days, choosing the highest score as reference and repeated during recovery of&#xD;
        consciousness or discharge.&#xD;
  &#xD;
        After informed consent by patient's legal representative or the primary caregiver, for the&#xD;
        purpose of the study, caregivers (including relatives, nurses, therapists, physicians) will&#xD;
        be asked to record all manoeuvres they feel are associated with potential pain, with a window&#xD;
        of observation of the rehabilitation and nursing staff of around one week to identify the&#xD;
        personalized painful stimulus (about the second week after admission at the rehabilitation&#xD;
        ward). Amongst them, the manoeuvres that consistently over time induced the most&#xD;
        motor/behaviour responses suggestive of pain perception, reported at least by 2 members of&#xD;
        the rehabilitation staff or by one of them and one caregiver, will be chosen as the&#xD;
        personalized stimulus (PS). NCS-R with standard stimulus (NCS-R-SS) and with personalized&#xD;
        stimulus (NCS-R-PS), will be recorded within 30 days after admission, alternating the order&#xD;
        of the 2 painful stimulations; CRS-R will be recorded accordingly, in parallel to NCS-R-SS&#xD;
        and NCS-R-PS and will be blindly recorded, at the same time, by two different rehabilitation&#xD;
        staff members, to assess inter-rater reliability, whereas two of them will repeat both&#xD;
        NCS-R_SS and NCS-R-PS during the same week to assess intra-rater reliability of both NCS-R-SS&#xD;
        and NCS-R-PS, with an interval of at least 6 hours from the last pain killer or anti-spastic&#xD;
        drugs administration, including GABAergic, anti-inflammatory drugs or opiates.&#xD;
  &#xD;
        Both CRS-R and NCS-R (SS and PS) will be repeated 1 month and 3 months after the first&#xD;
        assessment with the same procedures of the first time.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 9, 2019</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Evaluation of pain perception in non communicative patients</measure>
      <time_frame>Within 30 days after admission</time_frame>
      <description>Time 0</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Superiority of personalized painful stimulus versus standard stimulation</measure>
      <time_frame>30 days from T0</time_frame>
      <description>Time 1</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Possible parallel recovery of painful stimulus responsiveness and consciousness</measure>
      <time_frame>3 months from T0</time_frame>
      <description>Time 2</description>
    </other_outcome>
    <enrollment type="Anticipated">33</enrollment>
    <condition>Disorder of Consciousness</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Nociception Coma Scale-Revised</intervention_name>
      <description>Nociception Coma Scale-Revised Recorded after personalized painful stimulus</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients (age ≥ 18 years) diagnosed with Vegetative State (VS)/Unresponsive Wakefulness&#xD;
          Syndrome (UWS) or Minimally Conscious State (MCS) after severe acquired brain injury (ABI)&#xD;
          admitted to neurorehabilitation ceters.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  severe acquired brain injury (sABI),&#xD;
  &#xD;
            -  clinical history and neuroimaging (brain CT and/or MRI) and fulfilling the criteria&#xD;
               proposed for the sABI diagnosis:&#xD;
  &#xD;
            -  Glasgow Coma Scale (GCS) score ≤ 8 within 24 hours after injury,&#xD;
  &#xD;
            -  diagnosis of disorders of consciousness (DoC), (VS/UWS or MCS), according to the Coma&#xD;
               Recovery Scale-Revised (CRS-R),&#xD;
  &#xD;
            -  interval from the acute event of at least 3 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  history of previous brain injury,&#xD;
  &#xD;
            -  neurological or psychiatric disorders,&#xD;
  &#xD;
            -  alcohol or illicit drug abuse and concomitant spinal cord injury&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Rita Formisano</name>
        <address>
          <city>Rome</city>
          <zip>00179</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rita Formisano, physician</last_name>
        <phone>3311810674</phone>
        <email>r.formisano@hsantalucia.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>I.R.C.C.S. Fondazione Santa Lucia</investigator_affiliation>
      <investigator_full_name>Rita Formisano</investigator_full_name>
      <investigator_title>Director of Neuroriabilitazione 2</investigator_title>
    </responsible_party>
    <keyword>Disorder of consciousness</keyword>
    <keyword>Pain</keyword>
    <keyword>Responsiveness</keyword>
    <keyword>Nociception Coma Scale-Revised</keyword>
    <keyword>Coma Recovery Scale-Revised</keyword>
    <keyword>Non communicative patients</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Consciousness Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Enrollment of at least 50 patients with DoC in the participating centers</ipd_time_frame>
    </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/NCT06012357
  org study id: CE/PROG.603
  nct id: NCT06012357
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to compare Nociception Coma Scale-Revised Recorded
        (NCS-R) scores obtained with the standard pressure on fingernail bed (standard stimulus, SS)
        versus other personalized painful stimuli (PS), in non-communicative patients with disorders
        of consciousness (DoC), as indicated by professionals and caregivers involved in their care
        and rehabilitation. The study aims also to establish possible correlations between NCS-R and
        Coma Recovery Scale-Revised (CRS-R.) The main question : an integrated patient-centered
        approach for assessment of the physical pain, in which clinical measures and behavioral
        observations will be integrated, to understand and manage the pain intensity, may improve
        treatment and rehabilitation outcome. Specifically, a new version of NCS-R, adapted with PS,
        may produce more intentional and specific responses to pain-inducing maneuvers. Investigating
        pain perception in non-communicative patients, through recognition of a personalized source
        of nociception and pain, may avoid non specific, useless and harmful noxious tests (as with
        standard pain scales) and may provide tools for revealing nociception even in the lack of any
        response to standard clinical evaluation.
  
        Question 1: the superiority of personalized painful stimulus a standard painful stimulation
        in nin communicative patients.
  
        Question 2: the parallel recovery of painful stimuli responsiveness and consciousness
        Participants will Responsiveness and pain perception will be assessed respectively with the
        CRS-R and the NCS-R. Pain responses will be assessed by means of standard stimulus (NCS-R-SS,
        as used in the CRS-R) and personalized stimulation (NCS-R-PS), at admission and discharge.
  
        CRS-R will be administered within the first month after admission, at least 5 times in
        different days, choosing the highest score as reference and repeated during recovery of
        consciousness or discharge.
  
        After informed consent by patient's legal representative or the primary caregiver, for the
        purpose of the study, caregivers (including relatives, nurses, therapists, physicians) will
        be asked to record all manoeuvres they feel are associated with potential pain, with a window
        of observation of the rehabilitation and nursing staff of around one week to identify the
        personalized painful stimulus (about the second week after admission at the rehabilitation
        ward). Amongst them, the manoeuvres that consistently over time induced the most
        motor/behaviour responses suggestive of pain perception, reported at least by 2 members of
        the rehabilitation staff or by one of them and one caregiver, will be chosen as the
        personalized stimulus (PS). NCS-R with standard stimulus (NCS-R-SS) and with personalized
        stimulus (NCS-R-PS), will be recorded within 30 days after admission, alternating the order
        of the 2 painful stimulations; CRS-R will be recorded accordingly, in parallel to NCS-R-SS
        and NCS-R-PS and will be blindly recorded, at the same time, by two different rehabilitation
        staff members, to assess inter-rater reliability, whereas two of them will repeat both
        NCS-R_SS and NCS-R-PS during the same week to assess intra-rater reliability of both NCS-R-SS
        and NCS-R-PS, with an interval of at least 6 hours from the last pain killer or anti-spastic
        drugs administration, including GABAergic, anti-inflammatory drugs or opiates.
  
        Both CRS-R and NCS-R (SS and PS) will be repeated 1 month and 3 months after the first
        assessment with the same procedures of the first time.
  observational model: Other
  time perspective: Retrospective
  measure: Evaluation of pain perception in non communicative patients
  time frame: Within 30 days after admission
  description: Time 0
  measure: Superiority of personalized painful stimulus versus standard stimulation
  time frame: 30 days from T0
  description: Time 1
  measure: Possible parallel recovery of painful stimulus responsiveness and consciousness
  time frame: 3 months from T0
  description: Time 2
  intervention type: Diagnostic Test
  intervention name: Nociception Coma Scale-Revised
  description: Nociception Coma Scale-Revised Recorded after personalized painful stimulus
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: I.R.C.C.S. Fondazione Santa Lucia
  investigator full name: Rita Formisano
  investigator title: Director of Neuroriabilitazione 2
  mesh term: Consciousness Disorders
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Enrollment of at least 50 patients with DoC in the participating centers