<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/NCT02999659</url>
  </required_header>
  <id_info>
    <org_study_id>16-035</org_study_id>
    <nct_id>NCT02999659</nct_id>
  </id_info>
  <brief_title>Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome</brief_title>
  <acronym>Pupillometry</acronym>
  <official_title>Impact of Acute Cerebral Diseases on the Autonomous Nervous System: Progression and Correlation to Therapy and Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RWTH Aachen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The pupilometer determines the alteration of the pupil diameter after a defined light&#xD;
      stimulus. In this study data is collected from pupilometer measurements of patients with an&#xD;
      acute cerebral disease. The measurements take place during daily neurological routine&#xD;
      examinations. The values are compared to outcomes resulting from pupilometer measurements&#xD;
      done on patients having not an acute cerebral disease (e.g. cerebral aneurysm without&#xD;
      symptoms). The study aims to establish the not invasive method of pupillometry for detecting&#xD;
      neurological degradations early.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pupilometer determines the alteration of the pupil diameter after a defined light&#xD;
      stimulus providing information of the autonomic nerve system. The result collecting from&#xD;
      pupillometry is objective and more precise than the subjective-visual evaluation of the pupil&#xD;
      and its reactivity.&#xD;
&#xD;
      In this observational study data is collected from pupilometer measurements of patients with&#xD;
      an acute cerebral disease. The measurements take place during neurological routine&#xD;
      examinations. The first measurement is done during the initial diagnosing examination,&#xD;
      followed by daily measurements and ending with measurements after 3 and 6 month upon hospital&#xD;
      discharge. The values are compared to standard values resulting from pupilometer measurements&#xD;
      done on patients having non-acute cerebral disease (e.g. cerebral aneurysm without symptoms).&#xD;
      The study aims to establish the not invasive method of pupillometry for detecting&#xD;
      neurological degradations early.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of delayed cerebral ischemia (DCI)</measure>
    <time_frame>21 days</time_frame>
    <description>DCI is defined as the development of new focal neurological signs and/or deterioration in level of consciousness, lasting for more than 1 h, or the appearance of new infarctions on CT or MRI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of perfusion deficiency</measure>
    <time_frame>21 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transcranial Doppler (TCD) -fluency increase [cm/s]</measure>
    <time_frame>21 days</time_frame>
    <description>&gt; 150 cm/s absolute or increase &gt; 50 cm/s within 24 h</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digital subtraction angiography (DSA)</measure>
    <time_frame>day 7 ± 2 d</time_frame>
    <description>Detection of an angiographic vasospasm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glasgow Outcome Score (GOS)</measure>
    <time_frame>after 3 and 6 month</time_frame>
    <description>Standardized and objective description of the degree of recovery of patients suffered from a cerebral disease.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Pupillary Function, Abnormal</condition>
  <condition>Cerebral Aneurysm</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>The control group implies patients with non-acute cerebral disease (e.g. cerebral aneurysm without symptoms). The pupilometer data are once collected during ambulant routine examination. The patients do not undergo any further study related examinations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <description>The treatment group implies patients with an acute cerebral disease ensured by CT, MRI or spinal tap. Pupillometry measurements are done during neurological routine examinations. Generally, during the initial diagnosis examination, followed by daily routine measurements and after 3 and 6 month upon hospital discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pupilometer</intervention_name>
    <description>Device to measure change in pupil diameter due to a defined light stimulus.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study includes male and female patients suffering from a acute (treatment group) or&#xD;
        non-acute (control group) cerebral disease with a minimum age of 18 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female patient, age ≥ 18 years&#xD;
&#xD;
          -  signed consent&#xD;
&#xD;
          -  treatment group:&#xD;
&#xD;
          -  patient with acute, cerebral disease verified by CT, MRI or spinal tap&#xD;
&#xD;
          -  control group&#xD;
&#xD;
          -  patient with non-acute cerebral disease like a new diagnosed aneurysm without symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  female or male patient aged &lt; 18 years&#xD;
&#xD;
          -  absent of signed consent&#xD;
&#xD;
          -  persons who have a dependent or working relationship with the sponsor or investigator&#xD;
&#xD;
          -  persons who are sheltered in an institution by juridical or governmental order&#xD;
&#xD;
          -  concurrent participation in an other clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerrit Alexander Schubert, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uniklinik RWTH Aachen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christina Kalvelage, M. Sc.</last_name>
    <phone>0241 80 85062</phone>
    <email>ckalvelage@ukaachen.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gerrit Alexander Schubert, Prof.</last_name>
    <phone>0241 80 88480</phone>
    <email>gschubert@ukaachen.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Uniklinik RWTH Aachen</name>
      <address>
        <city>Aachen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.</citation>
    <PMID>21748035</PMID>
  </reference>
  <reference>
    <citation>Ciurea AV, Palade C, Voinescu D, Nica DA. Subarachnoid hemorrhage and cerebral vasospasm - literature review. J Med Life. 2013 Jun 15;6(2):120-5. Epub 2013 Jun 25.</citation>
    <PMID>23904869</PMID>
  </reference>
  <reference>
    <citation>Cocker KD, Moseley MJ, Stirling HF, Fielder AR. Delayed visual maturation: pupillary responses implicate subcortical and cortical visual systems. Dev Med Child Neurol. 1998 Mar;40(3):160-2. doi: 10.1111/j.1469-8749.1998.tb15440.x.</citation>
    <PMID>9566651</PMID>
  </reference>
  <reference>
    <citation>Fountas KN, Kapsalaki EZ, Machinis TG, Boev AN, Robinson JS, Troup EC. Clinical implications of quantitative infrared pupillometry in neurosurgical patients. Neurocrit Care. 2006;5(1):55-60. doi: 10.1385/NCC:5:1:55.</citation>
    <PMID>16960298</PMID>
  </reference>
  <reference>
    <citation>Rowland MJ, Hadjipavlou G, Kelly M, Westbrook J, Pattinson KT. Delayed cerebral ischaemia after subarachnoid haemorrhage: looking beyond vasospasm. Br J Anaesth. 2012 Sep;109(3):315-29. doi: 10.1093/bja/aes264.</citation>
    <PMID>22879655</PMID>
  </reference>
  <reference>
    <citation>Toi H, Matsumoto N, Yokosuka K, Matsubara S, Hirano K, Uno M. Prediction of cerebral vasospasm using early stage transcranial Doppler. Neurol Med Chir (Tokyo). 2013;53(6):396-402. doi: 10.2176/nmc.53.396.</citation>
    <PMID>23803618</PMID>
  </reference>
  <reference>
    <citation>Larson MD, Singh V. Portable infrared pupillometry in critical care. Crit Care. 2016 Jun 22;20(1):161. doi: 10.1186/s13054-016-1349-7.</citation>
    <PMID>27329287</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RWTH Aachen University</investigator_affiliation>
    <investigator_full_name>Gerrit Alexander Schubert</investigator_full_name>
    <investigator_title>apl. Prof. Dr. med. Gerrit Alexander Schubert</investigator_title>
  </responsible_party>
  <keyword>pupillometry</keyword>
  <keyword>autonomous nerve system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Pupil Disorders</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02999659
org study id: 16-035
nct id: NCT02999659
lead sponsor: 
has dmc: No
The pupilometer determines the alteration of the pupil diameter after a defined light
      stimulus. In this study data is collected from pupilometer measurements of patients with an
      acute cerebral disease. The measurements take place during daily neurological routine
      examinations. The values are compared to outcomes resulting from pupilometer measurements
      done on patients having not an acute cerebral disease (e.g. cerebral aneurysm without
      symptoms). The study aims to establish the not invasive method of pupillometry for detecting
      neurological degradations early.
The pupilometer determines the alteration of the pupil diameter after a defined light
      stimulus providing information of the autonomic nerve system. The result collecting from
      pupillometry is objective and more precise than the subjective-visual evaluation of the pupil
      and its reactivity.

      In this observational study data is collected from pupilometer measurements of patients with
      an acute cerebral disease. The measurements take place during neurological routine
      examinations. The first measurement is done during the initial diagnosing examination,
      followed by daily measurements and ending with measurements after 3 and 6 month upon hospital
      discharge. The values are compared to standard values resulting from pupilometer measurements
      done on patients having non-acute cerebral disease (e.g. cerebral aneurysm without symptoms).
      The study aims to establish the not invasive method of pupillometry for detecting
      neurological degradations early.
observational model: Case-Control
time perspective: Prospective
measure: Number of delayed cerebral ischemia (DCI)
time frame: 21 days
description: DCI is defined as the development of new focal neurological signs and/or deterioration in level of consciousness, lasting for more than 1 h, or the appearance of new infarctions on CT or MRI.
measure: Number of perfusion deficiency
time frame: 21 days
measure: Transcranial Doppler (TCD) -fluency increase [cm/s]
time frame: 21 days
description: > 150 cm/s absolute or increase > 50 cm/s within 24 h
measure: Digital subtraction angiography (DSA)
time frame: day 7 ± 2 d
description: Detection of an angiographic vasospasm
measure: Glasgow Outcome Score (GOS)
time frame: after 3 and 6 month
description: Standardized and objective description of the degree of recovery of patients suffered from a cerebral disease.
arm group label: Control group
description: The control group implies patients with non-acute cerebral disease (e.g. cerebral aneurysm without symptoms). The pupilometer data are once collected during ambulant routine examination. The patients do not undergo any further study related examinations.
arm group label: Treatment group
description: The treatment group implies patients with an acute cerebral disease ensured by CT, MRI or spinal tap. Pupillometry measurements are done during neurological routine examinations. Generally, during the initial diagnosis examination, followed by daily routine measurements and after 3 and 6 month upon hospital discharge.
intervention type: Device
intervention name: Pupilometer
description: Device to measure change in pupil diameter due to a defined light stimulus.
arm group label: Control group
arm group label: Treatment group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gerrit Alexander Schubert, Prof.
role: Principal Investigator
affiliation: Uniklinik RWTH Aachen
last name: Christina Kalvelage, M. Sc.
phone: 0241 80 85062
email: ckalvelage@ukaachen.de
last name: Gerrit Alexander Schubert, Prof.
phone: 0241 80 88480
email: gschubert@ukaachen.de
facility: 
status: Recruiting
country: Germany
citation: Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.
PMID: 21748035
citation: Ciurea AV, Palade C, Voinescu D, Nica DA. Subarachnoid hemorrhage and cerebral vasospasm - literature review. J Med Life. 2013 Jun 15;6(2):120-5. Epub 2013 Jun 25.
PMID: 23904869
citation: Cocker KD, Moseley MJ, Stirling HF, Fielder AR. Delayed visual maturation: pupillary responses implicate subcortical and cortical visual systems. Dev Med Child Neurol. 1998 Mar;40(3):160-2. doi: 10.1111/j.1469-8749.1998.tb15440.x.
PMID: 9566651
citation: Fountas KN, Kapsalaki EZ, Machinis TG, Boev AN, Robinson JS, Troup EC. Clinical implications of quantitative infrared pupillometry in neurosurgical patients. Neurocrit Care. 2006;5(1):55-60. doi: 10.1385/NCC:5:1:55.
PMID: 16960298
citation: Rowland MJ, Hadjipavlou G, Kelly M, Westbrook J, Pattinson KT. Delayed cerebral ischaemia after subarachnoid haemorrhage: looking beyond vasospasm. Br J Anaesth. 2012 Sep;109(3):315-29. doi: 10.1093/bja/aes264.
PMID: 22879655
citation: Toi H, Matsumoto N, Yokosuka K, Matsubara S, Hirano K, Uno M. Prediction of cerebral vasospasm using early stage transcranial Doppler. Neurol Med Chir (Tokyo). 2013;53(6):396-402. doi: 10.2176/nmc.53.396.
PMID: 23803618
citation: Larson MD, Singh V. Portable infrared pupillometry in critical care. Crit Care. 2016 Jun 22;20(1):161. doi: 10.1186/s13054-016-1349-7.
PMID: 27329287
responsible party type: Principal Investigator
investigator affiliation: RWTH Aachen University
investigator full name: Gerrit Alexander Schubert
investigator title: apl. Prof. Dr. med. Gerrit Alexander Schubert
mesh term: Intracranial Aneurysm
mesh term: Pupil Disorders
mesh term: Aneurysm
sharing ipd: Undecided