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

Primary Purpose

Intractable Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evoked related potentials
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Intractable Epilepsy focused on measuring Event-related Potentials (ERP), Intracerebral recordings, Presurgical evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GHU Paris - Sainte Anne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Whole group

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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)
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)

Full Information

First Posted
March 18, 2021
Last Updated
July 6, 2021
Sponsor
Centre Hospitalier St Anne
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1. Study Identification

Unique Protocol Identification Number
NCT04810832
Brief Title
EXPRESON-IN : Intracerebral Recordings of P3a Responses to Expressive Own-names
Acronym
EXPRESON-IN
Official Title
EXPRESON-INTRA : Intracerebral Recordings of P3a Responses to Own-names Uttered by Expressive and Neutral Voices in Pharmacoresistant Epilepsy Adult Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
September 9, 2022 (Anticipated)
Study Completion Date
September 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intractable Epilepsy
Keywords
Event-related Potentials (ERP), Intracerebral recordings, Presurgical evaluation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Evoked related potentials
Intervention Description
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.
Primary Outcome Measure Information:
Title
Latencies cartography of intracranial responses to own-name uttered by neutral voice
Description
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
Time Frame
1 year
Title
Latencies cartography of intracranial responses to own-name uttered by expressive voices
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Comparison between brain responses to own-name uttered by expressive voices recorded with intracerebral electrodes versus scalp electrodes
Description
Qualitative comparison between scalp and intracranial recordings with the expressive voices paradigms (comparison of the latencies of the recorded responses)
Time Frame
1 year
Title
Comparison between brain responses to own-name uttered by neutral voices recorded with intracerebral electrodes versus scalp electrodes
Description
Qualitative comparison between scalp and intracranial recordings with the neutral voices paradigms (comparison of the latencies of the recorded responses)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
GHU Paris - Sainte Anne
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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