Healthy VolunteersElectro-PulceNCT04702919
Brain Changes in EEG and Brain Pulsatility to Novel Stimuli (Electro-PulCe)
An observational study of Healthy Volunteers, run by University Hospital, Tours at 1 site in France.
Trial summary
The oddball paradigm is one of the most widely used methods of brain exploration for the study of attentional processes. It allows the measurement, by means of an Electro-Enchephalogram (EEG), of evoked potentials reflecting the electrophysiological reactivity to the detection of novel stimuli within a stream of… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Registration and Auditive oddball task
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2022to 17 Jun 2022
- Phase
- Observational
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteer
Who may be able to join
- Age between 18 and 45 years old included
- Normal hearing
Who cannot join
- History of neurologic, psychiatric or cardiologic diseases (stroke, severe head trauma, mood disorder, psychotic disorder, coronary syndrome, heart rhythm disorder, etc.)
- Treatment which could impact Brain Tissue Pulsatility (Beta-Blockers, Neuroleptics, etc...) and electrophysiological (Sedatives, Benzodiazepines, etc...) parameters.
- Legal protection measures
- Opposition to data processing
Trial locations and contacts
1 site in 1 country.
France1 site
Paedopsychiatry department, University Hospital, Tours
Tours, 37044
About this study
Official title: Modifications Electrophysiologiques et de la Pulsatilité Cérébrale à la détection de Stimuli Nouveaux (Electro-PulCe)
The oddball paradigm is one of the most widely used methods of brain exploration for the study of attentional processes. It allows the measurement, by means of an Electro-Enchephalogram (EEG), of evoked potentials reflecting the electrophysiological reactivity to the detection of novel stimuli within a stream of standard stimuli.
Other studies have recently suggested that, in addition to neuronal activation, certain other physiological processes related to cerebrovascular reactivity, such as the Brain Tissue Pulsatility (BTP), could also be sensitive to various cognitive processes and in particular to attentional processes.
Read more
In one of the latest studies published in collaboration with our group, it was shown that the amplitude of the electrophysiological response classically associated with attentional activity (P300 wave) was significantly correlated with the amplitude of BTP, suggesting the involvement of cerebrovascular processes in attentional functions. Nevertheless, in this study, the two methods of EEG and Tissue Pulsatility Imaging (TPI) were not synchronized, since TPI was performed at rest and not during the oddball task itself, and to date no study has sought to couple the methods of EEG and ultrasound TPI in an oddball paradigm, for a simultaneous characterization of neuronal and cerebrovascular responsiveness during attentional processes.
The general objective of this study will be to evaluate changes in BTP during the detection of novel stimuli in an oddball task in healthy volunteers, in which the two methods of TPI and EEG will be coupled and synchronized.
Read the detailed description
The oddball paradigm is one of the most widely used methods of brain exploration for the study of attentional processes. It allows the measurement, by means of an Electro-Enchephalogram (EEG), of evoked potentials reflecting the electrophysiological reactivity to the detection of novel stimuli within a stream of standard stimuli. Numerous studies have thus used the oddball paradigm to identify the neuronal reactivity involved in attentional orientation towards target stimuli.
Other studies have recently suggested that, in addition to neuronal activation, certain other physiological processes related to cerebrovascular reactivity, such as the Brain Tissue Pulsatility (BTP), could also be sensitive to various cognitive processes and in particular to attentional processes. Ultrasound measurement of BTP is made possible by recent advances in both the development of ultrasound equipment and ultrasound signal processing. Our team and others have validated the measurement of BTP by ultrasound (Tissue Pulsatility Imaging - TPI) in healthy volunteers and clinical populations, and our results suggest that the mechanisms of BTP are significantly influenced by cerebrovascular physiology.
In one of the latest studies published in collaboration with our group, it was shown that the amplitude of the electrophysiological response classically associated with attentional activity (P300 wave) was significantly correlated with the amplitude of BTP, suggesting the involvement of cerebrovascular processes in attentional functions. Nevertheless, in this study, the two methods of EEG and TPI were not synchronized, since TPI was performed at rest and not during the oddball task itself, and to date no study has sought to couple the methods of EEG and ultrasound TPI in an oddball paradigm, for a simultaneous characterization of neuronal and cerebrovascular responsiveness during attentional processes.
The general objective of this study will be to evaluate changes in BTP during the detection of novel stimuli in an oddball task in healthy volunteers, in which the two methods of TPI and EEG will be coupled and synchronized.
- Conditions
- Healthy Volunteers
- Being tested
- Registration, Auditive oddball task
- Keywords
- Brain Tissue Pulsatility (BTP), Electroencephalogram (EEG), Auditive oddball task, Tissue Pulsatility Imaging (TPI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistrationOther
Synchronized recording of BTP in ultrasound, brain activity by EEG, heart rate and blood pressure.
Auditive oddball taskOther
Presentation of an auditory sequence, comprising 'Standard' (probability of occurrence: p = 0.90) and 'Deviants' (p = 0.10, targets) sounds via loudspeakers.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described Receives: Other: Registration; Other: Auditive oddball task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brain Tissue Pulsatility indexes
Measured by the Tissue Pulsatility Imaging technique - TPI
Measured: Baseline and during the auditive oddball task (20 minutes)
Secondary outcomes (3)
P300 wave
Evoked potential P300 measured by Electroencephalogram (EEG)
Measured: Baseline and during the auditive oddball task (20 minutes)
Heart Rate changes and Heart Rate Variability
Measured by electrocardiogram (ECG)
Measured: Baseline and during the auditive oddball task (20 minutes)
Arterial pressure blood
Measured by a non-invasive and continuous blood pressure bracelet.
Measured: Baseline and during the auditive oddball task (20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start21 Feb 2022
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Desmidt, Md-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702919
- Sponsor's protocol ID
- RIPH3-RNI19 / Electro-Pulce
- Other IDs
- IdRCB
- Acronym
- Electro-Pulce
- Status last verified
- Feb 2022
- First submitted
- 4 Jan 2021
- Last updated
- 19 Jul 2022
- 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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifications Electrophysiologiques et de la Pulsatilité Cérébrale à la détection de Stimuli Nouveaux (Electro-PulCe)
- ClinicalTrials.gov ID
- NCT04702919
- Acronym / sponsor ID
- Electro-Pulce / RIPH3-RNI19 / Electro-Pulce
- Conditions
- Healthy Volunteers
- Keywords
- Brain Tissue Pulsatility (BTP), Electroencephalogram (EEG), Auditive oddball task, Tissue Pulsatility Imaging (TPI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 11 Jan 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.
The oddball paradigm is one of the most widely used methods of brain exploration for the study of attentional processes. It allows the measurement, by means of an Electro-Enchephalogram (EEG), of evoked potentials reflecting the electrophysiological reactivity to the detection of novel stimuli within a stream of standard stimuli.
Other studies have recently suggested that, in addition to neuronal activation, certain other physiological processes related to cerebrovascular reactivity, such as the Brain Tissue Pulsatility (BTP), could also be sensitive to various cognitive processes and in particular to attentional processes.
In one of the latest studies published in collaboration with our group, it was shown that the amplitude of the electrophysiological response classically associated with attentional activity (P300 wave) was significantly correlated with the amplitude of BTP, suggesting the involvement of cerebrovascular processes in attentional functions. Nevertheless, in this study, the two methods of EEG and Tissue Pulsatility Imaging (TPI) were not synchronized, since TPI was performed at rest and not during the oddball task itself, and to date no study has sought to couple the methods of EEG and ultrasound TPI in an oddball paradigm, for a simultaneous characterization of neuronal and cerebrovascular responsiveness during attentional processes.
The general objective of this study will be to evaluate changes in BTP during the detection of novel stimuli in an oddball task in healthy volunteers, in which the two methods of TPI and EEG will be coupled and synchronized.
Detailed description
The oddball paradigm is one of the most widely used methods of brain exploration for the study of attentional processes. It allows the measurement, by means of an Electro-Enchephalogram (EEG), of evoked potentials reflecting the electrophysiological reactivity to the detection of novel stimuli within a stream of standard stimuli. Numerous studies have thus used the oddball paradigm to identify the neuronal reactivity involved in attentional orientation towards target stimuli.
Other studies have recently suggested that, in addition to neuronal activation, certain other physiological processes related to cerebrovascular reactivity, such as the Brain Tissue Pulsatility (BTP), could also be sensitive to various cognitive processes and in particular to attentional processes. Ultrasound measurement of BTP is made possible by recent advances in both the development of ultrasound equipment and ultrasound signal processing. Our team and others have validated the measurement of BTP by ultrasound (Tissue Pulsatility Imaging - TPI) in healthy volunteers and clinical populations, and our results suggest that the mechanisms of BTP are significantly influenced by cerebrovascular physiology.
In one of the latest studies published in collaboration with our group, it was shown that the amplitude of the electrophysiological response classically associated with attentional activity (P300 wave) was significantly correlated with the amplitude of BTP, suggesting the involvement of cerebrovascular processes in attentional functions. Nevertheless, in this study, the two methods of EEG and TPI were not synchronized, since TPI was performed at rest and not during the oddball task itself, and to date no study has sought to couple the methods of EEG and ultrasound TPI in an oddball paradigm, for a simultaneous characterization of neuronal and cerebrovascular responsiveness during attentional processes.
The general objective of this study will be to evaluate changes in BTP during the detection of novel stimuli in an oddball task in healthy volunteers, in which the two methods of TPI and EEG will be coupled and synchronized.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: Registration, Other: Auditive oddball task |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteer
Key inclusion criteria (2 listed)
- Age between 18 and 45 years old included
- Normal hearing
Key exclusion criteria (4 listed)
- History of neurologic, psychiatric or cardiologic diseases (stroke, severe head trauma, mood disorder, psychotic disorder, coronary syndrome, heart rhythm disorder, etc.)
- Treatment which could impact Brain Tissue Pulsatility (Beta-Blockers, Neuroleptics, etc...) and electrophysiological (Sedatives, Benzodiazepines, etc...) parameters.
- Legal protection measures
- Opposition to data processing
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 |
|---|---|---|
| RegistrationSynchronized recording of BTP in ultrasound, brain activity by EEG, heart rate and blood pressure. | Other | Healthy volunteers |
| Auditive oddball taskPresentation of an auditory sequence, comprising 'Standard' (probability of occurrence: p = 0.90) and 'Deviants' (p = 0.10, targets) sounds via loudspeakers. | Other | Healthy volunteers |
Primary outcome
Change in Brain Tissue Pulsatility indexes
Time frame: Baseline and during the auditive oddball task (20 minutes)
Measured by the Tissue Pulsatility Imaging technique - TPI
3 secondary outcomes
P300 wave
Time frame: Baseline and during the auditive oddball task (20 minutes)
Heart Rate changes and Heart Rate Variability
Time frame: Baseline and during the auditive oddball task (20 minutes)
Arterial pressure blood
Time frame: Baseline and during the auditive oddball task (20 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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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.
Thomas Desmidt, Md-PhD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by University Hospital, Tours 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Brain Tissue Pulsatility indexes (time frame: Baseline and during the auditive oddball task (20 minutes)). 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 19 Jul 2022; AzTrials last refreshed its copy on 1 Nov 2026.