<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/NCT02254213</url>
  </required_header>
  <id_info>
    <org_study_id>MC-CT-003</org_study_id>
    <nct_id>NCT02254213</nct_id>
  </id_info>
  <brief_title>Intra-individual Stability in Electroencephalography (EEG) Parameters</brief_title>
  <official_title>Intra-individual Stability in EEG Parameters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mentis Cura</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Icelandic Center for Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mentis Cura</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective is to evaluate the stability of EEG features on an individual level.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2005</start_date>
  <completion_date type="Actual">August 2007</completion_date>
  <primary_completion_date type="Actual">August 2005</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>Quantitative EEG (qEEG) features</measure>
    <time_frame>Three months</time_frame>
    <description>qEEG features are extracted from 10 separate EEG recordings from each individual in the cohort.</description>
  </primary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Stability of EEG Features in Humans</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EEG recording</intervention_name>
    <description>A short EEG recording is performed 10 times over the span of three months.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        15 individuals in the age range of 50 - 90 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age must be in the range 50 - 90 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Outside required age range&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristinn Johnsen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mentis Cura</affiliation>
  </overall_official>
  <results_reference>
    <citation>Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.</citation>
    <PMID>17765604</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intra-individual stability, EEG</keyword>
  <!-- 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/NCT02254213
org study id: MC-CT-003
nct id: NCT02254213
lead sponsor: 
collaborator: 
has dmc: No
The main objective is to evaluate the stability of EEG features on an individual level.
observational model: Cohort
time perspective: Prospective
measure: Quantitative EEG (qEEG) features
time frame: Three months
description: qEEG features are extracted from 10 separate EEG recordings from each individual in the cohort.
intervention type: Other
intervention name: EEG recording
description: A short EEG recording is performed 10 times over the span of three months.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kristinn Johnsen, PhD
role: Principal Investigator
affiliation: Mentis Cura
citation: Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.
PMID: 17765604
responsible party type: Sponsor