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Cognitive Assessment by the Mean of Event Related Potentials (PEC)

Primary Purpose

Brain Injuries

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Event Related Potentials recording
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Injuries

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Control subjects

Inclusion Criteria:

  • adults between 18 and 80,
  • written informed consent obtained from the subject,
  • covers by social insurance,
  • absence of psychoactive drug intake in the week preceding the examination or alcohol intake the day before the exam

Exclusion Criteria:

  • pregnant patients or breastfeeding,
  • sensory deficit incompatible with the participation in tne study,
  • person under a legal protection measure, under guardianship,
  • psychoactive drug intake in the week preceding the examination or alcohol intake the day before the exam

Patients :

Inclusion Criteria:

  • adults between 18 and 80,
  • written informed consent obtained from the patient or his relatives,
  • covers by social insurance,
  • patients with either focal or diffuse brain damage drom trauma, vascular, tumor or other aetiologies, or with a history of neonatal or congenital diseases,
  • patients with selective cognitive disorders or with altered states of consciousness

Exclusion Criteria:

  • Pregnant patients or breastfeeding,
  • sensory deficit incompatible with the participation in the study

Sites / Locations

  • CHU of LimogesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Event Related Potentials

Arm Description

Outcomes

Primary Outcome Measures

Cognitive processing assessment
Specific Event Related Potential (ERP) presence. ERP measurements indicate if a patient or control subject has or has not performed the task we asked him to even if the subject performs the task covertly

Secondary Outcome Measures

Scalp topographies of ERPs
Links between the performance of a given task and the brain areas cognitive function.
Cognitive assessment by means of specialized scales
Patients will be examined clinically with dedicated specialized scales: CRS-R (Coma Recovery Scale- Revised), GOSE (Glasgow Outcome Scale Extended) and other dedicated scorings.

Full Information

First Posted
June 27, 2013
Last Updated
March 8, 2015
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT01899924
Brief Title
Cognitive Assessment by the Mean of Event Related Potentials
Acronym
PEC
Official Title
Cognitive Assessment of Patients With Brain Injuries by the Mean of Event
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to describe differential cognitive processing of various stimuli by a population of control subjects and a population of patients with selective cognitive deficits or altered states of consciousness by using dedicated ERP paradigms and high-density EEG picked up system.
Detailed Description
In order to test the relevance of theoretical models of cognitive functions, examination of patients with cerebral lesions is of great interest. Thus, the goal of this study is to assess cognitive processing in patients by a combination of behavioural clinical tests and ERP (event related potentials) specific markers. Indeed, ERP technique makes it possible to ascertain that a patient or control subject has or has not performed the task we asked him to even if the subject performs the task covertly. From these ERPs markers, we can investigate their respective cortical generators. By comparing the results obtained in both healthy and pathological populations, we will be able to appreciate differential processing of the same stimuli by two different populations and try to correlate these differences with specific cerebral lesions and with different outcomes.We previously demonstrated the relevance of this approach in the field of disorders of consciousness patients and we project to enrich this specific approach by the addition of new markers and by its extension to other fields of cognitive and behavioural neurology. The procedure will be the following. After obtaining written informed consent, patients will be examined clinically with dedicated specialized scales (for example the CRS-R for disorders of consciousness patients). Then, we will probe event related potentials by stimulating these patients with various stimuli embedded in well-designed paradigms while their scalp EEG will be recorded. Following different steps of signal processing the mean ERPs according to conditions will be extracted and statistical analysis will be performed. At one year from the recording, outcome will be collected and correlated with the obtained ERPs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Event Related Potentials
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Event Related Potentials recording
Primary Outcome Measure Information:
Title
Cognitive processing assessment
Description
Specific Event Related Potential (ERP) presence. ERP measurements indicate if a patient or control subject has or has not performed the task we asked him to even if the subject performs the task covertly
Time Frame
Day1
Secondary Outcome Measure Information:
Title
Scalp topographies of ERPs
Description
Links between the performance of a given task and the brain areas cognitive function.
Time Frame
Day 1
Title
Cognitive assessment by means of specialized scales
Description
Patients will be examined clinically with dedicated specialized scales: CRS-R (Coma Recovery Scale- Revised), GOSE (Glasgow Outcome Scale Extended) and other dedicated scorings.
Time Frame
Day1, Day 356

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Control subjects Inclusion Criteria: adults between 18 and 80, written informed consent obtained from the subject, covers by social insurance, absence of psychoactive drug intake in the week preceding the examination or alcohol intake the day before the exam Exclusion Criteria: pregnant patients or breastfeeding, sensory deficit incompatible with the participation in tne study, person under a legal protection measure, under guardianship, psychoactive drug intake in the week preceding the examination or alcohol intake the day before the exam Patients : Inclusion Criteria: adults between 18 and 80, written informed consent obtained from the patient or his relatives, covers by social insurance, patients with either focal or diffuse brain damage drom trauma, vascular, tumor or other aetiologies, or with a history of neonatal or congenital diseases, patients with selective cognitive disorders or with altered states of consciousness Exclusion Criteria: Pregnant patients or breastfeeding, sensory deficit incompatible with the participation in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frederic Faugeras, Dr
Phone
05 55 05 65 65
Email
frederic.faugeras@laposte.net
Facility Information:
Facility Name
CHU of Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic Faugeras, Dr
Phone
05 55 05 65 65
Email
frederic.faugeras@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Frederic Faugeras, Dr
First Name & Middle Initial & Last Name & Degree
Deborah Postil, Dr
First Name & Middle Initial & Last Name & Degree
Elodie Couve-Deacon, Dr

12. IPD Sharing Statement

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Cognitive Assessment by the Mean of Event Related Potentials

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