Cognitive Assessment by the Mean of Event Related Potentials
PEC
Cognitive Assessment of Patients With Brain Injuries by the Mean of Event
1 other identifier
interventional
320
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedMarch 10, 2015
March 1, 2015
4 years
June 27, 2013
March 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Day1
Secondary Outcomes (2)
Scalp topographies of ERPs
Day 1
Cognitive assessment by means of specialized scales
Day1, Day 356
Study Arms (1)
Event Related Potentials
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 :
- 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
- Pregnant patients or breastfeeding,
- sensory deficit incompatible with the participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU of Limoges
Limoges, 87042, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2013
First Posted
July 16, 2013
Study Start
July 1, 2013
Primary Completion
July 1, 2017
Study Completion
July 1, 2018
Last Updated
March 10, 2015
Record last verified: 2015-03