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Evaluation of Consciousness by Brain-computer Interface in Severely Brain Damaged Patients

NCT03998930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-07-19

No results posted yet for this study

Summary

The objective of this study is to show that the measurement of auditory and vibro-tactile evoked potentials, or the recording of the EEG signal during a motor imaging task, can be used in routine clinical situations to explore the state of consciousness of subjects in Non-responsive Awakening (or Chronic Vegetative State) or in Minimal Consciousness (or relational state) after a severe brain injury.

Assumptions :

* Correlation between patient response rates obtained with the brain-machine interface and their clinical consciousness score (Coma Recovery Scale Revised score)
* Differentiation of the parameters of the evoked potentials P300 between patients in a vegetative state and those in a state of minimal consciousness

Conditions

  • Traumatic Brain Injury With Prolonged Loss of Consciousness
  • Stroke
  • Brain Hypoxia

Interventions

OTHER

Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R)

Paraclinical evaluation of consciousness by the brain-machine interface by measuring evoked potentials P300 auditory and vibrotactile and recording the EEG signal during a motor imaging task

Sponsors & Collaborators

  • M2H laboratory, Montpellier University

    collaborator OTHER

  • IMT Mines Alès, Alès, France

    collaborator UNKNOWN

  • University Hospital, Montpellier

    collaborator OTHER

  • Hôpital d'Uzès, Uzès, France

    collaborator UNKNOWN

  • Clinique Fontfroide, Montpellier, France

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-06
Primary Completion
2018-08-21
Completion
2018-08-21

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03998930 on ClinicalTrials.gov