Optimizing the Evaluation of Awareness in Disorders of Consciousness

Centre Hospitalier Universitaire de Besancon28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Disorders of Consciousness

Interventions

high-density electroencephalographyDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: standard stimulations: 28 days after recruiting patients

Central Contacts

Damien Gabriel, PhD

CONTACT

381219148 dgabriel@chu-besancon.fr

Data from ClinicalTrials.gov

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