Intractable EpilepsyEXPRESON-INNCT04810832
EXPRESON-IN : Intracerebral Recordings of P3a Responses to Expressive Own-names
A study testing Evoked related potentials in people with Intractable Epilepsy, run by Centre Hospitalier St Anne at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intractable Epilepsy
- What is being tested?
- Evoked related potentials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2020to 9 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Deafness
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intractable Epilepsy
- Being tested
- Evoked related potentials
- Keywords
- Event-related Potentials (ERP), Intracerebral recordings, Presurgical evaluation
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evoked related potentialsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Evoked related potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 year
Secondary outcomes (2)
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)
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start9 Sep 2020
- Primary completion9 Sep 2022 (estimated)
- Study completion9 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intractable EpilepsyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810832
- Sponsor's protocol ID
- 2020-A01340-39
- Acronym
- EXPRESON-IN
- Status last verified
- Jan 2021
- First submitted
- 18 Mar 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXPRESON-INTRA : Intracerebral Recordings of P3a Responses to Own-names Uttered by Expressive and Neutral Voices in Pharmacoresistant Epilepsy Adult Patients
- ClinicalTrials.gov ID
- NCT04810832
- Acronym / sponsor ID
- EXPRESON-IN / 2020-A01340-39
- Conditions
- Intractable Epilepsy
- Keywords
- Event-related Potentials (ERP), Intracerebral recordings, Presurgical evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 9 Sep 2022 (estimated)
- Study completion
- 9 Sep 2023 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Whole group | Experimental | Other: Evoked related potentialsThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Deafness
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evoked related potentialsEvoked 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. | Other | Whole group |
Primary outcome
Latencies cartography of intracranial responses to own-name uttered by neutral voice
Time frame: 1 year
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
Time frame: 1 year
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
2 secondary outcomes
Comparison between brain responses to own-name uttered by expressive voices recorded with intracerebral electrodes versus scalp electrodes
Time frame: 1 year
Comparison between brain responses to own-name uttered by neutral voices recorded with intracerebral electrodes versus scalp electrodes
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evoked related potentials in people with Intractable Epilepsy, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latencies cartography of intracranial responses to own-name uttered by neutral voice (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.