EXPRESON-IN : Intracerebral Recordings of P3a Responses to Expressive Own-names (EXPRESON-IN)

EXPRESON-INTRA : Intracerebral Recordings of P3a Responses to Own-names Uttered by Expressive and Neutral Voices in Pharmacoresistant Epilepsy Adult Patients

Neurophysiologic evaluation of disorders of consciousness (DOC) patients in intensive care unit include late auditory evoked potentials. It allows the physicians to record cerebral responses of patients to auditory stimuli and in particularly to their own name (as the P3a response). Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm and notably using more expressive stimuli.

Here the investigators investigate the intracerebral correlates of the P3a responses recorded on the scalp with neutral and more expressive stimuli.

Study Overview

• Status: Active, not recruiting
• Conditions: Intractable Epilepsy
• Intervention / Treatment: Other: Evoked related potentials

Detailed Description

Late auditory evoked potentials (as P3 wave) are used in neurophysiology to assess the level of consciousness in DOC (disorder of consciousness) patients. The P3 wave, elicited by listening standard and deviant stimuli, corresponds to the activation of a frontoparietal network and is considered to reflect a cognitive attention task. Using the own name of the patient as deviant stimuli improve the ability to detect the P3 wave because of the particularly relevance of this stimulus for the patient.

In human cognition, to identify the expressivity valence of a voice is essential. Neural processing of expressive voices should involves more widespread brain areas than neutral voices processing.

Here the investigators investigate the intracerebral correlates of the P3a responses recorded on the scalp to own-name stimuli uttered by neutral and more expressive voices (positive : smiling voice or negative : rough voice) in adult pharmacoresistant epilepsy patients.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • GHU Paris - Sainte Anne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Intractable focal epilepsy with undergoing pre-surgical evaluation
• intracerebral electrodes implantation in auditory cortices, temporal lobe, superior temporal gyrus, limbic areas, frontal lobe
• Given Consent to inclusion

Exclusion Criteria:

• Deafness
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Whole group; The whole group undergo the two phases of the study: 1/ They listen successively the 3 oddball paradigms in the department of neurophysiology : P3 own-name recorded by listening to a smiling voice P3 own-name recorded by listening to a neutral voice P3 own-name recorded by listening to a rough voice; 2/ They listen successively the same 3 oddball paradigms in the neurosurgical department, during their intractable epilepsy presurgical evaluation : P3 own-name recorded by listening to a smiling voice P3 own-name recorded by listening to a neutral voice P3 own-name recorded by listening to a rough voice

Other: Evoked related potentials; Evoked related potentials are performed for each patient during each paradigm (neutral voice and expressive voices): with scalp electrodes in the department of neurophysiology; with intracranial electrodes in the department of neurosurgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latencies cartography of intracranial responses to own-name uttered by neutral voice	Analyse of latencies of intracranial responses recorded to own-name uttered by neutral voice to build a map of the brain process of this responses	1 year
Latencies cartography of intracranial responses to own-name uttered by expressive voices	Analyse of latencies of intracranial responses recorded to own-name uttered by expressive voices to build a map of the brain process of this responses	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between brain responses to own-name uttered by expressive voices recorded with intracerebral electrodes versus scalp electrodes	Qualitative comparison between scalp and intracranial recordings with the expressive voices paradigms (comparison of the latencies of the recorded responses)	1 year
Comparison between brain responses to own-name uttered by neutral voices recorded with intracerebral electrodes versus scalp electrodes	Qualitative comparison between scalp and intracranial recordings with the neutral voices paradigms (comparison of the latencies of the recorded responses)	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Anticipated): September 9, 2022
• Study Completion (Anticipated): September 9, 2023

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Event-related Potentials (ERP); Intracerebral recordings; Presurgical evaluation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: 2020-A01340-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No