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

NCT04702919 | Completed

• 2 other identifiers: RIPH3-RNI19 / Electro-PulceIdRCB
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Brain Tissue Pulsatility (BTP); Electroencephalogram (EEG); Auditive oddball task; Tissue Pulsatility Imaging (TPI)

Outcome Measures

Primary Outcomes (1)

• Change in Brain Tissue Pulsatility indexes

  Measured by the Tissue Pulsatility Imaging technique - TPI

  Baseline and during the auditive oddball task (20 minutes)

Secondary Outcomes (3)

• P300 wave

  Baseline and during the auditive oddball task (20 minutes)

• Heart Rate changes and Heart Rate Variability

  Baseline and during the auditive oddball task (20 minutes)

• Arterial pressure blood

  Baseline and during the auditive oddball task (20 minutes)

Study Arms (1)

Healthy volunteers

Other: Registration; Other: Auditive oddball task

Interventions

Registration OTHER

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

Healthy volunteers

Auditive oddball task OTHER

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

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteer

You may qualify if:

• Age between 18 and 45 years old included
• Normal hearing

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Paedopsychiatry department, University Hospital, Tours

Tours, 37044, France

Location

Study Officials

• Thomas Desmidt, Md-PhD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 11, 2021
• Study Start: February 21, 2022
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-02

Locations

FR (1)