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
About this trial
This is an interventional diagnostic trial for Disorders of Consciousness
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
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
NCT ID
NCT02628639
First Posted
December 8, 2015
Last Updated
December 10, 2015
Sponsor
Centre Hospitalier Universitaire de Besancon
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
background
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Optimizing the Evaluation of Awareness in Disorders of Consciousness
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