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

June 23, 2026 updated by: University Hospital, Limoges

Cognitive Assessment of Patients With Brain Injuries by the Mean of Event

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • CHU of Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Event Related Potentials
Behavioral: Event Related Potentials recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive processing assessment
Time Frame: Day1
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
Day1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scalp topographies of ERPs
Time Frame: Day 1
Links between the performance of a given task and the brain areas cognitive function.
Day 1
Cognitive assessment by means of specialized scales
Time Frame: Day1, Day 356

Patients will be examined clinically with dedicated specialized scales:

CRS-R (Coma Recovery Scale- Revised), GOSE (Glasgow Outcome Scale Extended) and other dedicated scorings.
Day1, Day 356

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimated)

July 16, 2013

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I12011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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