<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/NCT03034902</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-16-0481</org_study_id>
    <nct_id>NCT03034902</nct_id>
  </id_info>
  <brief_title>Detection of Area of Ischemia in Patients With Subacute Stroke Via a Hybrid EEG-fNIRS Brain-computer Interface</brief_title>
  <official_title>Detection of Area of Ischemia in Patients With Subacute Stroke Via a Hybrid EEG-fNIRS Brain-computer Interface</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to determine whether a combined electroencephalography&#xD;
      (EEG) and functional near infrared spectroscopy (fNIRS) recording is able to detect changes&#xD;
      in brain activity and blood flow after stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The collaborating investigator has moved and cannot collect further data.&#xD;
  </why_stopped>
  <start_date type="Actual">February 9, 2017</start_date>
  <completion_date type="Actual">June 20, 2017</completion_date>
  <primary_completion_date type="Actual">June 20, 2017</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with abnormal blood flow as assessed by fNIRS</measure>
    <time_frame>immediately at the time of combined EEG and fNIRS for up to 60 minutes</time_frame>
    <description>Abnormal blood flow is determined by comparing a part of the patient's brain not affected by stroke to a part of the patient's brain affected by stroke.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormal neuronal activity as assessed by EEG</measure>
    <time_frame>immediately at the time of combined EEG and fNIRS for up to 60 minutes</time_frame>
    <description>Abnormal neuronal activity is determined by comparing a part of the patient's brain not affected by stroke to a part of the patient's brain affected by stroke.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Combined EEG and fNIRS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EEG is electroencephalography. fNIRS is functional near infrared spectroscopy. The EEG+NIRS recordings will be obtained via an extended EEG cap that is applied to the subject's head. Changes in neuronal activity and hemodynamics will be measured.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Combined EEG and fNIRS</intervention_name>
    <description>The EEG+NIRS recordings will be obtained via an extended EEG cap that is applied to the subject's head. Changes in neuronal activity and hemodynamics will be measured. The EEG component is the microEEG by BioSignal Group, UA. The fNIRS component is the NIRScout 24x32, NIRx Medizintechnik GmbH, Germany</description>
    <arm_group_label>Combined EEG and fNIRS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with a subacute ischemic stroke with symptom onset within 8 weeks&#xD;
&#xD;
          -  Must have a measurable deficit on the National Institute of Health Stroke Scale&#xD;
             (NIHSS)&#xD;
&#xD;
          -  Able to give and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aphasia&#xD;
&#xD;
          -  Underlying dementia&#xD;
&#xD;
          -  Any chronic neurological disorder&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Non-ambulatory (ambulation with assistance will be included)&#xD;
&#xD;
          -  Modified Rankin Score (mRS) &gt; 3&#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>Paulina B Sergot, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Paulina Sergot</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03034902
org study id: HSC-MS-16-0481
nct id: NCT03034902
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this research study is to determine whether a combined electroencephalography
      (EEG) and functional near infrared spectroscopy (fNIRS) recording is able to detect changes
      in brain activity and blood flow after stroke.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Number of participants with abnormal blood flow as assessed by fNIRS
time frame: immediately at the time of combined EEG and fNIRS for up to 60 minutes
description: Abnormal blood flow is determined by comparing a part of the patient's brain not affected by stroke to a part of the patient's brain affected by stroke.
measure: Number of participants with abnormal neuronal activity as assessed by EEG
time frame: immediately at the time of combined EEG and fNIRS for up to 60 minutes
description: Abnormal neuronal activity is determined by comparing a part of the patient's brain not affected by stroke to a part of the patient's brain affected by stroke.
arm group label: Combined EEG and fNIRS
arm group type: Experimental
description: EEG is electroencephalography. fNIRS is functional near infrared spectroscopy. The EEG+NIRS recordings will be obtained via an extended EEG cap that is applied to the subject's head. Changes in neuronal activity and hemodynamics will be measured.
intervention type: Device
intervention name: Combined EEG and fNIRS
description: The EEG+NIRS recordings will be obtained via an extended EEG cap that is applied to the subject's head. Changes in neuronal activity and hemodynamics will be measured. The EEG component is the microEEG by BioSignal Group, UA. The fNIRS component is the NIRScout 24x32, NIRx Medizintechnik GmbH, Germany
arm group label: Combined EEG and fNIRS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paulina B Sergot, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Paulina Sergot
investigator title: Assistant Professor
mesh term: Stroke
mesh term: Ischemia