Optimizing the Evaluation of Awareness in Disorders of Consciousness

NCT ID: NCT02628639

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Disorders of Consciousness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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electroencephalography recording

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

Group Type EXPERIMENTAL

high-density electroencephalography

Intervention Type DEVICE

Interventions

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high-density electroencephalography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Régis Aubry, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service douleur - soins palliatifs

Central Contacts

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Damien Gabriel, PhD

Role: CONTACT

Phone: 381219148

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 25741272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25644421 (View on PubMed)

Other Identifiers

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15/482

Identifier Type: -

Identifier Source: org_study_id