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/NCT05992194</url>
    </required_header>
    <id_info>
      <org_study_id>SBN_2023_2</org_study_id>
      <nct_id>NCT05992194</nct_id>
    </id_info>
    <brief_title>Repeatability Assessment of Neurovisual Tasks for the Construction of a New Concussion Monitoring Tool (SPORTICARE)</brief_title>
    <acronym>SPORTiCARE</acronym>
    <official_title>Exploratory Study Analyzing the Repeatability of Neurovisual Tasks for the Construction of a New Concussion Monitoring Tool</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondation Ophtalmologique Adolphe de Rothschild</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>
        Traumatic brain injury (TBI) is a condition that occurs when a mechanical blow to the head&#xD;
        causes damage to the brain. The diagnosis of this pathology requires the evaluation of&#xD;
        several dimensions, including clinical symptoms, physical signs, cognitive disorders,&#xD;
        behavioral and sleep disturbances and state of consciousness. This multidimensional approach&#xD;
        provides a comprehensive and accurate assessment of head injury and its severity.&#xD;
  &#xD;
        The Berlin Consensus of the International Conference on Concussion in Contact Risk Sports&#xD;
        held in Berlin in 2016 (McCrory et al., 2017) emphasized that the management of a CTE must be&#xD;
        multimodal and multidisciplinary.&#xD;
  &#xD;
        This expert consensus converged on a tool that is now the most widely used in protocols&#xD;
        studying concussion in sports at risk of BTI. This tool, the SCAT 5 (Sports Concussion&#xD;
        Assessment Tool), combines symptom assessment, cognitive examination, neurological&#xD;
        examination (oculomotricity, balance) and immediate and delayed memory.&#xD;
  &#xD;
        However, it requires the intervention of a medical expert to assess the clinical signs of the&#xD;
        concussed athlete. Hänninen et al (2021) showed that test-retest reproducibility was very&#xD;
        good for the clinical symptomatology subscore, but poor or average for the subscores&#xD;
        summarizing cognitive tests and balance assessment.&#xD;
  &#xD;
        Clinicians now need to be able to better assess the severity of damage following head injury,&#xD;
        and to monitor the patient's progress. This will improve the management of concussed athletes&#xD;
        right up to their eventual return to sporting activity.&#xD;
  &#xD;
        The ultimate aim of our project is to develop and optimize an easily exportable multimodal&#xD;
        concussion assessment tool, based on the use of a virtual reality headset, which will enable&#xD;
        us to objectively characterize the state and evolution of a subject after a TCE. This will&#xD;
        enable the assessment of neuro-visual functions and compensations in the concussed patient,&#xD;
        revealing a higher attentional cost characterized by instability of orthostatic control,&#xD;
        higher blink frequency and larger pupil size.&#xD;
  &#xD;
        The multimodal tool will be built from the results of various tests:&#xD;
  &#xD;
          -  Standardized oculomotor tasks(pro-saccades, anti-saccades, smooth pursuit, memory guided&#xD;
             saccades, self paced saccades)&#xD;
  &#xD;
          -  Orthostatic balance control to assess postural compensations and estimate attentional&#xD;
             cost during oculomotor tasks.&#xD;
  &#xD;
          -  Pupil dynamics using the Pupil Cycle Time (PCT) test. The aim of this exploratory study&#xD;
             is to determine the repeatability of measurements provided by the SPORTiCARE virtual&#xD;
             reality headset during different tasks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of repeatability when performing pro-saccades</measure>
      <time_frame>Day 0</time_frame>
      <description>Latency (ms)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of repeatability when performing anti-saccades</measure>
      <time_frame>Day 0</time_frame>
      <description>Latency (ms)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of repeatability when performing memory tricks</measure>
      <time_frame>Day 0</time_frame>
      <description>Positional error (degrees)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of repeatability of the number of saccades when performing self-paced saccades</measure>
      <time_frame>Day 0</time_frame>
      <description>number of saccades (n) performed between the two targets in the allotted time (15 seconds)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of repeatability of pupil cycle time when performing self-paced saccades</measure>
      <time_frame>Day 0</time_frame>
      <description>Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of repeatability when performing pro-saccades</measure>
      <time_frame>Between Day 7 and Day 21</time_frame>
      <description>Latency (ms)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of repeatability when performing anti-saccades</measure>
      <time_frame>Between Day 7 and Day 21</time_frame>
      <description>Latency (ms)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of repeatability when performing memory tricks</measure>
      <time_frame>Between Day 7 and Day 21</time_frame>
      <description>Positional error (degrees)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of repeatability of the number of saccades when performing self-paced saccades</measure>
      <time_frame>Between Day 7 and Day 21</time_frame>
      <description>number of saccades (n) performed between the two targets in the allotted time (15 seconds)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of repeatability of pupil cycle time when performing self-paced saccades</measure>
      <time_frame>Between Day 7 and Day 21</time_frame>
      <description>Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)</description>
    </primary_outcome>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Traumatic Brain Injury</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>multimodal oculomotor measurements</intervention_name>
      <description>Visual assessment to ensure that the subject meets the inclusion and non-inclusion criteria, including anamnesis and the following visual tests: Lang stereotest, H-test ocular motility, convergence, masking and accommodative rock.&#xD;
  Evaluation by experimenter A (60 min)&#xD;
  Neuro-ophthalmological tests on screen&#xD;
  Neuro-ophthalmological tests in VR headset&#xD;
  Evaluation by experimenter B (60 min)&#xD;
  Neuro-ophthalmological tests on screen&#xD;
  Neuro-ophthalmological tests in VR helmet The sequence of experimenters A-B or B-A will be randomized.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Group of 25 healthy volunteers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Visual acuity of 10/10,&#xD;
  &#xD;
            -  Express consent to participate in the study,&#xD;
  &#xD;
            -  Affiliated (or beneficiary) of a social insurance scheme.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of Cranioencephalic Trauma,&#xD;
  &#xD;
            -  Protected persons: pregnant women, parturients, nursing mothers, persons deprived of&#xD;
               their liberty by judicial or administrative decision, minors, and persons subject to a&#xD;
               legal protection measure (guardianship or curatorship).&#xD;
  &#xD;
            -  Subjects suffering from a degenerative disease or any other illness which could&#xD;
               interfere with the evaluations planned during this study (migraine, balance disorders,&#xD;
               vertigo).&#xD;
  &#xD;
            -  Subjects with ophthalmological pathologies affecting visual functions (oculomotor&#xD;
               dysfunction, diplopia, strabismus).&#xD;
  &#xD;
            -  Known history of convergence and/or accommodation insufficiency.&#xD;
  &#xD;
            -  Subject declaring to the investigator in charge of anamnesis, consumption of&#xD;
               psychoactive and psychotropic drugs, medications (anti-anxiety, antidepressant,&#xD;
               anticonvulsant, opiate, analgesic, anti-hypertensive) or level 3 medications, which&#xD;
               may have effects on vision.&#xD;
  &#xD;
            -  Unavailability of participant for evaluation sessions.&#xD;
  &#xD;
            -  Inability to comply with study task instructions.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 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>Brain Injuries</mesh_term>
      <mesh_term>Brain Injuries, Traumatic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05992194
  org study id: SBN_2023_2
  nct id: NCT05992194
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Traumatic brain injury (TBI) is a condition that occurs when a mechanical blow to the head
        causes damage to the brain. The diagnosis of this pathology requires the evaluation of
        several dimensions, including clinical symptoms, physical signs, cognitive disorders,
        behavioral and sleep disturbances and state of consciousness. This multidimensional approach
        provides a comprehensive and accurate assessment of head injury and its severity.
  
        The Berlin Consensus of the International Conference on Concussion in Contact Risk Sports
        held in Berlin in 2016 (McCrory et al., 2017) emphasized that the management of a CTE must be
        multimodal and multidisciplinary.
  
        This expert consensus converged on a tool that is now the most widely used in protocols
        studying concussion in sports at risk of BTI. This tool, the SCAT 5 (Sports Concussion
        Assessment Tool), combines symptom assessment, cognitive examination, neurological
        examination (oculomotricity, balance) and immediate and delayed memory.
  
        However, it requires the intervention of a medical expert to assess the clinical signs of the
        concussed athlete. Hänninen et al (2021) showed that test-retest reproducibility was very
        good for the clinical symptomatology subscore, but poor or average for the subscores
        summarizing cognitive tests and balance assessment.
  
        Clinicians now need to be able to better assess the severity of damage following head injury,
        and to monitor the patient's progress. This will improve the management of concussed athletes
        right up to their eventual return to sporting activity.
  
        The ultimate aim of our project is to develop and optimize an easily exportable multimodal
        concussion assessment tool, based on the use of a virtual reality headset, which will enable
        us to objectively characterize the state and evolution of a subject after a TCE. This will
        enable the assessment of neuro-visual functions and compensations in the concussed patient,
        revealing a higher attentional cost characterized by instability of orthostatic control,
        higher blink frequency and larger pupil size.
  
        The multimodal tool will be built from the results of various tests:
  
          -  Standardized oculomotor tasks(pro-saccades, anti-saccades, smooth pursuit, memory guided
             saccades, self paced saccades)
  
          -  Orthostatic balance control to assess postural compensations and estimate attentional
             cost during oculomotor tasks.
  
          -  Pupil dynamics using the Pupil Cycle Time (PCT) test. The aim of this exploratory study
             is to determine the repeatability of measurements provided by the SPORTiCARE virtual
             reality headset during different tasks.
  observational model: Cohort
  time perspective: Prospective
  measure: Assessment of repeatability when performing pro-saccades
  time frame: Day 0
  description: Latency (ms)
  measure: Assessment of repeatability when performing anti-saccades
  time frame: Day 0
  description: Latency (ms)
  measure: Assessment of repeatability when performing memory tricks
  time frame: Day 0
  description: Positional error (degrees)
  measure: Assessment of repeatability of the number of saccades when performing self-paced saccades
  time frame: Day 0
  description: number of saccades (n) performed between the two targets in the allotted time (15 seconds)
  measure: Assessment of repeatability of pupil cycle time when performing self-paced saccades
  time frame: Day 0
  description: Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)
  measure: Assessment of repeatability when performing pro-saccades
  time frame: Between Day 7 and Day 21
  description: Latency (ms)
  measure: Assessment of repeatability when performing anti-saccades
  time frame: Between Day 7 and Day 21
  description: Latency (ms)
  measure: Assessment of repeatability when performing memory tricks
  time frame: Between Day 7 and Day 21
  description: Positional error (degrees)
  measure: Assessment of repeatability of the number of saccades when performing self-paced saccades
  time frame: Between Day 7 and Day 21
  description: number of saccades (n) performed between the two targets in the allotted time (15 seconds)
  measure: Assessment of repeatability of pupil cycle time when performing self-paced saccades
  time frame: Between Day 7 and Day 21
  description: Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)
  intervention type: Other
  intervention name: multimodal oculomotor measurements
  description: Visual assessment to ensure that the subject meets the inclusion and non-inclusion criteria, including anamnesis and the following visual tests: Lang stereotest, H-test ocular motility, convergence, masking and accommodative rock.
  Evaluation by experimenter A (60 min)
  Neuro-ophthalmological tests on screen
  Neuro-ophthalmological tests in VR headset
  Evaluation by experimenter B (60 min)
  Neuro-ophthalmological tests on screen
  Neuro-ophthalmological tests in VR helmet The sequence of experimenters A-B or B-A will be randomized.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor
  mesh term: Brain Injuries
  mesh term: Brain Injuries, Traumatic
  sharing ipd: No