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

Intractable Epilepsy Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04810832
• Other study ID #: 2020-A01340-39
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: September 9, 2023

Study information

• Verified date: January 2021
• Source: Centre Hospitalier St Anne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: September 9, 2023
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Intractable Epilepsy

Intervention

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.

Locations

Country	Name	City	State
France	GHU Paris - Sainte Anne	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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