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Clinical Trials/NCT03706170
NCT03706170
Completed
Not Applicable

Emotion Assessment to Study Consciousness in Awakening Patients

Hospices Civils de Lyon1 site in 1 country15 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Persistent Vegetative State
Sponsor
Hospices Civils de Lyon
Enrollment
15
Locations
1
Primary Endpoint
electrodermal response
Status
Completed
Last Updated
last year

Overview

Brief Summary

After a coma, one important challenge is the detection of awareness with patients with disorders of consciousness. For some patients, the only behavioral manifestation indicative of awareness is an appropriate emotional response. Studies show that the use of a particular conditioning - with delay - appears to be an objective solution to study the conscious perception of an emotion in none-communicating people. Until now, emotions of patients suffering disorder of consciousness (DOC) have been scarcely studied. It has been proved that some awakening patients have vegetative reactions following an emotional stimulus, but the investigator can't confirm whether or not the emotional experience of the patient is conscious.

The investigator's main purpose is to study emotional reactions from patients suffering a disorder of consciousness.

The investigator hypothesize that some patients have preserved reflexes reaction to the emotional stimuli while others could demonstrate a conscious emotional experience.

In order to answer these questions, the study is designed to record in a single session: (i) physiological vegetative reactions (electrodermal, pupillary responses and heart rate) to emotional stimuli both in DOC patients and healthy controls; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence. The investigator plan to include patients vegetative patients (n=15); minimally conscious patients (n=15); acquired brain injured patients without conscious disorder (n=15) and healthy participants (n=15).

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
September 29, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • For Patients :
  • age between 18 and 80
  • acquired brain lesion (brain injury, stroke, anoxia) with a delay since the insult superior to 1 month
  • level of consciousness assessed with the coma recovery scale revised (CRS-R)
  • patient with health insurance
  • informed consent signed by the patients or his representative
  • For Healthy participants:
  • age between 18 and 80
  • participant able to understand instructions and normal hearing
  • patient with health insurance

Exclusion Criteria

  • For Patients :
  • non controlled epilepsy
  • dysautonomic crisis
  • unstable medical state
  • pregnancy or breath feeding for women
  • Persons under guardianship, curatorship
  • For Healthy participants:
  • neurological disorder
  • pregnancy or breath feeding for women
  • Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty

Outcomes

Primary Outcomes

electrodermal response

Time Frame: at Day 1

skin conductance response measured with trans-cutaneus electrodes

Secondary Outcomes

  • pupillary response(at Day 1)
  • heart rate modification(at day 1)
  • Variation of the intensity of different Event Related Potentials(at Day 2)

Study Sites (1)

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