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Clinical Trials/NCT02628639
NCT02628639UnknownNot Applicable

Using High-resolution Electroencephalography to Optimize the Evaluation of Awareness in Patients With Disorders of Consciousness

Centre Hospitalier Universitaire de Besancon0 sites28 target enrollmentStarted: January 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
28
Primary Endpoint
Number of participants showing differences of electrophysiological activity after personalized but not standard stimulation protocols

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

electroencephalography recording

Experimental

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

Intervention: high-density electroencephalography (Device)

Outcomes

Primary Outcomes

Number of participants showing differences of electrophysiological activity after personalized but not standard stimulation protocols

Time Frame: standard stimulations: 28 days after recruiting patients

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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