Comparison Between High-density Electroencephalography and Conventional Electroencephalography for Comatose Patients

NCT ID: NCT02588482

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-17

Study Completion Date

2020-07-08

Brief Summary

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The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients

Detailed Description

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Conditions

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Post Anoxic Coma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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electroencephalography recording

Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously

Group Type EXPERIMENTAL

high-density electroencephalography

Intervention Type DEVICE

Auditory stimulations during electroencephalography recording

Conventional electroencephalography

Intervention Type DEVICE

Auditory stimulations during electroencephalography recording

Interventions

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high-density electroencephalography

Auditory stimulations during electroencephalography recording

Intervention Type DEVICE

Conventional electroencephalography

Auditory stimulations during electroencephalography recording

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* post anoxic coma
* over 18 years old
* agreement from families
* alive 4 days after the beginning of coma

Exclusion Criteria

* traumatic coma
* non-traumatic but not anoxic coma
* patients with severe comorbidity previous to coma
* refusal of families to participate to the study
* contraindication to a high-density electroencephalography exam
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Moulin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service de neurologie, CHRU Besançon

Locations

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CHRU Besançon

Besançon, Franche-Comte, France

Site Status

Countries

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France

Other Identifiers

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R/2012/46

Identifier Type: -

Identifier Source: org_study_id

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