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

Healthy Volunteers Clinical Trial

— Electro-Pulce  

Official title:

Modifications Electrophysiologiques et de la Pulsatilité Cérébrale à la détection de Stimuli Nouveaux (Electro-PulCe)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04702919
• Other study ID #: RIPH3-RNI19 / Electro-Pulce
• Secondary ID: IdRCB
• Status: Completed
• Start date: February 21, 2022
• Est. completion date: June 17, 2022

Study information

• Verified date: February 2022
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
France	Paedopsychiatry department, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Brain Tissue Pulsatility indexes	Measured by the Tissue Pulsatility Imaging technique - TPI	Baseline and during the auditive oddball task (20 minutes)
Secondary	P300 wave	Evoked potential P300 measured by Electroencephalogram (EEG)	Baseline and during the auditive oddball task (20 minutes)
Secondary	Heart Rate changes and Heart Rate Variability	Measured by electrocardiogram (ECG)	Baseline and during the auditive oddball task (20 minutes)
Secondary	Arterial pressure blood	Measured by a non-invasive and continuous blood pressure bracelet.	Baseline and during the auditive oddball task (20 minutes)