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Optimizing the Evaluation of Awareness in Disorders of Consciousness (CONPHIDENSE)

Primary Purpose

Disorders of Consciousness

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high-density electroencephalography
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Disorders of Consciousness

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients in a vegetative state or a minimally conscious state
  • agreement from families

Exclusion Criteria:

  • patients with akinetic mutism or locked-in syndrome
  • patients in a coma
  • patients with damages in the inner or middle ear
  • contraindication to a high-density electroencephalography exam

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    electroencephalography recording

    Arm Description

    Cerebral measurements from high-density electroencephalography after the presentation of personalized stimulations

    Outcomes

    Primary Outcome Measures

    Number of participants showing differences of electrophysiological activity after personalized but not standard stimulation protocols
    Depending of the personalized stimulation protocol, the differences of electrophysiological activity can the presence of event-related potentials (N100, mismatch negativity, P300, etc.) or alterations of neural oscillations. The personalized stimulation protocol will be chosen according to the families' feeling of a presence.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 8, 2015
    Last Updated
    December 10, 2015
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02628639
    Brief Title
    Optimizing the Evaluation of Awareness in Disorders of Consciousness
    Acronym
    CONPHIDENSE
    Official Title
    Using High-resolution Electroencephalography to Optimize the Evaluation of Awareness in Patients With Disorders of Consciousness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate whether personalized stimulations can improve the detection of electrophysiological signs of awareness in patients with disorders of consciousness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disorders of Consciousness

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    electroencephalography recording
    Arm Type
    Experimental
    Arm Description
    Cerebral measurements from high-density electroencephalography after the presentation of personalized stimulations
    Intervention Type
    Device
    Intervention Name(s)
    high-density electroencephalography
    Primary Outcome Measure Information:
    Title
    Number of participants showing differences of electrophysiological activity after personalized but not standard stimulation protocols
    Description
    Depending of the personalized stimulation protocol, the differences of electrophysiological activity can the presence of event-related potentials (N100, mismatch negativity, P300, etc.) or alterations of neural oscillations. The personalized stimulation protocol will be chosen according to the families' feeling of a presence.
    Time Frame
    standard stimulations: 28 days after recruiting patients

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients in a vegetative state or a minimally conscious state agreement from families Exclusion Criteria: patients with akinetic mutism or locked-in syndrome patients in a coma patients with damages in the inner or middle ear contraindication to a high-density electroencephalography exam
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Damien Gabriel, PhD
    Phone
    381219148
    Ext
    33
    Email
    dgabriel@chu-besancon.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Régis Aubry, MD, PhD
    Organizational Affiliation
    Service douleur - soins palliatifs
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25741272
    Citation
    Pazart L, Gabriel D, Cretin E, Aubry R. Neuroimaging for detecting covert awareness in patients with disorders of consciousness: reinforce the place of clinical feeling! Front Hum Neurosci. 2015 Feb 17;9:78. doi: 10.3389/fnhum.2015.00078. eCollection 2015. No abstract available.
    Results Reference
    background
    PubMed Identifier
    25644421
    Citation
    Gabriel D, Henriques J, Comte A, Grigoryeva L, Ortega JP, Cretin E, Brunotte G, Haffen E, Moulin T, Aubry R, Pazart L. Substitute or complement? Defining the relative place of EEG and fMRI in the detection of voluntary brain reactions. Neuroscience. 2015 Apr 2;290:435-44. doi: 10.1016/j.neuroscience.2015.01.053. Epub 2015 Jan 30.
    Results Reference
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    Optimizing the Evaluation of Awareness in Disorders of Consciousness

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