Optimizing the Evaluation of Awareness in Disorders of Consciousness

Disorders of Consciousness Clinical Trial

— CONPHIDENSE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02628639
• Other study ID #: 15/482
• Status: Not yet recruiting
• Phase: N/A
• First received: December 8, 2015
• Last updated: December 10, 2015
• Start date: January 2016

Study information

• Verified date: December 2015
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Damien Gabriel, PhD
• Phone: 381219148
• Email: dgabriel[@]chu-besancon.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorders of Consciousness

Intervention

Device:
• high-density electroencephalography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	standard stimulations: 28 days after recruiting patients	No