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EEG Classification System for Dementia

Primary Purpose

Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EEG recording
Sponsored by
Mentis Cura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dementia focused on measuring Dementia, Diagnosis, Electroencephalography

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age of participant in the range of 50-90 years

Exclusion Criteria:

  • Outside required age range

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    EEG

    Arm Description

    A non-invasive EEG recording

    Outcomes

    Primary Outcome Measures

    Classification system for dementia based on EEG
    The EEGs recorded in the trial will be categorized into controls or predefined clinical groups based on the participants' clinical diagnosis. The classification system will be constructed using this categorization.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 29, 2014
    Last Updated
    October 22, 2014
    Sponsor
    Mentis Cura
    Collaborators
    Landspitali University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02273921
    Brief Title
    EEG Classification System for Dementia
    Official Title
    EEG Classification System for Dementia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mentis Cura
    Collaborators
    Landspitali University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this study is to construct a large database of EEG recordings from elderly individuals in predefined groups. The purpose of this database is to select groups of EEG recordings from the database in order to compare the electrophysiology, as measured by EEG, of the groups. In the clinical trial part all individuals are treated exactly the same and are therefore considered a single group. The categorization is performed during the data analysis. The groups in the data analysis will initially be based on the following: Healthy controls Mild Cognitive Impairment Alzheimers Disease (AD) Lewy-body Dementia Parkinsons Disease Dementia Vascular Dementia (VaD) Frontotemporal Dementia (FTD) Depression Other groups will be added if needed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia
    Keywords
    Dementia, Diagnosis, Electroencephalography

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    2000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EEG
    Arm Type
    No Intervention
    Arm Description
    A non-invasive EEG recording
    Intervention Type
    Other
    Intervention Name(s)
    EEG recording
    Intervention Description
    EEG is recorded once for each participant
    Primary Outcome Measure Information:
    Title
    Classification system for dementia based on EEG
    Description
    The EEGs recorded in the trial will be categorized into controls or predefined clinical groups based on the participants' clinical diagnosis. The classification system will be constructed using this categorization.
    Time Frame
    The quality of the classification system will be evaluated regularly, at least every 6 months, up to 6 years.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age of participant in the range of 50-90 years Exclusion Criteria: Outside required age range
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jón Snædal, MD
    Organizational Affiliation
    Landspitali University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20153691
    Citation
    Snaedal J, Johannesson GH, Gudmundsson TE, Gudmundsson S, Pajdak TH, Johnsen K. The use of EEG in Alzheimer's disease, with and without scopolamine - a pilot study. Clin Neurophysiol. 2010 Jun;121(6):836-41. doi: 10.1016/j.clinph.2010.01.008. Epub 2010 Feb 12.
    Results Reference
    background
    PubMed Identifier
    17765604
    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.
    Results Reference
    background
    PubMed Identifier
    22922592
    Citation
    Snaedal J, Johannesson GH, Gudmundsson TE, Blin NP, Emilsdottir AL, Einarsson B, Johnsen K. Diagnostic accuracy of statistical pattern recognition of electroencephalogram registration in evaluation of cognitive impairment and dementia. Dement Geriatr Cogn Disord. 2012;34(1):51-60. doi: 10.1159/000339996. Epub 2012 Aug 23.
    Results Reference
    result

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    EEG Classification System for Dementia

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