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

NCT04810832 | Unknown

• 1 other identifier: 2020-A01340-39
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intractable Epilepsy

Keywords

Event-related Potentials (ERP); Intracerebral recordings; Presurgical evaluation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Comparison between brain responses to own-name uttered by expressive voices recorded with intracerebral electrodes versus scalp electrodes

  1 year

• Comparison between brain responses to own-name uttered by neutral voices recorded with intracerebral electrodes versus scalp electrodes

  1 year

Study Arms (1)

Whole group

EXPERIMENTAL

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

Interventions

Evoked related potentials OTHER

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.

Whole group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Deafness
• Pregnancy

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Paris - Sainte Anne

Paris, 75014, France

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open and prospective study. Evoked related potentials are recorded on the scalp and with intracranial electrodes for each participant while they listen 3 paradigms successively and in a random order: i) their own name uttered by a smiling voice ii) their own name uttered by a neutral voice iii) their own name uttered by a rough voice

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 23, 2021
• Study Start: September 9, 2020
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2023
• Last Updated: July 9, 2021

Record last verified: 2021-01

Locations

FR (1)