Electro-Pulce: Brain Changes in EEG and Brain Pulsatility to Novel Stimuli (Electro-PulCe)

Sponsor
University Hospital, Tours (Other)
Overall Status
Completed
CT.gov ID
NCT04702919
Collaborator
(none)
25
1
3.8
6.6

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Registration
  • Other: Auditive oddball task

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

Study Type:
Observational
Actual Enrollment :
25 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Modifications Electrophysiologiques et de la Pulsatilité Cérébrale à la détection de Stimuli Nouveaux (Electro-PulCe)
Actual Study Start Date :
Feb 21, 2022
Actual Primary Completion Date :
Jun 17, 2022
Actual Study Completion Date :
Jun 17, 2022

Arms and Interventions

Arm Intervention/Treatment
Healthy volunteers

Other: Registration
Synchronized recording of BTP in ultrasound, brain activity by EEG, heart rate and blood pressure.

Other: Auditive oddball task
Presentation of an auditory sequence, comprising 'Standard' (probability of occurrence: p = 0.90) and 'Deviants' (p = 0.10, targets) sounds via loudspeakers.

Outcome Measures

Primary Outcome Measures

  1. Change in Brain Tissue Pulsatility indexes [Baseline and during the auditive oddball task (20 minutes)]

    Measured by the Tissue Pulsatility Imaging technique - TPI

Secondary Outcome Measures

  1. P300 wave [Baseline and during the auditive oddball task (20 minutes)]

    Evoked potential P300 measured by Electroencephalogram (EEG)

  2. Heart Rate changes and Heart Rate Variability [Baseline and during the auditive oddball task (20 minutes)]

    Measured by electrocardiogram (ECG)

  3. Arterial pressure blood [Baseline and during the auditive oddball task (20 minutes)]

    Measured by a non-invasive and continuous blood pressure bracelet.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age between 18 and 45 years old included

  • Normal hearing

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Paedopsychiatry department, University Hospital, Tours Tours France 37044

Sponsors and Collaborators

  • University Hospital, Tours

Investigators

  • Principal Investigator: Thomas Desmidt, Md-PhD, University Hospital, Tours

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT04702919
Other Study ID Numbers:
  • RIPH3-RNI19 / Electro-Pulce
  • IdRCB
First Posted:
Jan 11, 2021
Last Update Posted:
Jul 19, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Tours

Study Results

No Results Posted as of Jul 19, 2022