NCT04175119

Brief Summary

The brain is composed of a set of areas specialized in specific computations whose outputs need to be transferred to other specialized areas for cognition to emerge. To account for context-dependent behaviors, the information must be flexibly routed through the fixed anatomy of the brain. The aim of this project is to test a general framework for this flexible communication between brain areas based on nested oscillations. The general idea is that internally-driven slow oscillations (\<20Hertz) either set-up or prevent the communication between brain areas. Stimulus-driven gamma oscillations (\>30Hertz), nested in the slow oscillations, can then be directed to task-relevant areas of the network. This multimodal, multi-scale approach uses magnetoencephalography using a 3-Dimensional (3D) printed individual head-cast system and transcranial stimulation in experiments manipulating visual processing, attention and memory to test core predictions of this framework. The theoretical approach and the methodological development used in this basic science study will provide the basis for future fundamental and clinical research.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

November 25, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

5.3 years

First QC Date

November 13, 2019

Last Update Submit

November 19, 2025

Conditions

Keywords

Brain

Outcome Measures

Primary Outcomes (1)

  • The composite characteristics of the brain oscillations (frequency, synchronization, and interaction between brain oscillations in and between different brain regions and networks)

    The primary outcome measure is measured using fMRI bold signals (experiment 1), and brain signals obtained through electroencephalography (experiment 1, 3) and magnetoenecephalography (experiment 1, 3), depending on the sessions. The signals are then transformed during analyses and patterns in the composite characteristics are identified.

    up to 17 months

Secondary Outcomes (2)

  • The coupling of behavioral responses to stimuli with physiological responses in the brain.

    up to 17 months

  • Coupling of brain oscillation characteristics in responses to the "flickering" effect

    up to 17 months

Study Arms (1)

Main study group

EXPERIMENTAL

All participants signed up for experiment 1, 2, or 3 complete the same protocol (1 study arm) with an intent for intra-subject correlational analyses.

Device: Visual attention/perception tasks in healthy participants

Interventions

The participants complete visual attention and perception tasks while fMRI, EEG, and MEG record brain signals. The tasks acquire responses with a visual saccade or button presses which are coupled to brain responses. These responses are then analyzed to identify patterns of communication between brain areas (within-subject). The flickering stimuli (experiment 1) may alter oscillations in the brain, while participants complete visual attention and perception tasks, leading to a secondary outcome measure distinct from the button presses. The procedure concerning the flickers will be the same for participants. The tACS (experiment 2) delivers input in addition to gathering output while participants complete visual attention and perception tasks. A sinusoidal current at a chosen frequency interacts with the brain's natural oscillations and alters responses. Participants will have sham sessions of tACS as well (there is no group division), The sham will be compared with the stimulation

Main study group

Eligibility Criteria

Age20 Years - 36 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Right handed
  • Registered with the French healthcare system
  • Motivated to participate in the study
  • Normal or corrected vision
  • Adequate knowledge of French to be able to follow directions and give informed consent
  • Capacity to listen and follow study instructions
  • Use of contraception (in sexually active women)
  • BMI between 18.5 and 30
  • Informed consent for participation in the study

You may not qualify if:

  • For All Experiments:
  • Persons with :
  • Sleep disorders, neurological or psychiatric illnesses or a history of such problems that could impact quality/variability of data or cooperation and retention of the subject in the study
  • Migraines or light-sensitive epilepsy
  • Regular use of medications that impact the central nervous system
  • Regular use of medications, such as opioids and antidepressants, including Selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants
  • Severe hearing loss
  • Skin conditions or allergies
  • Chronic pain, or any other medical conditions conducive to pain sensitivity
  • A history of stroke or recent trauma to the head
  • A pacemaker, insulin or other pump, neurostimulator, cochlear implants or other hearing aid, metal stents, prosthesis, or implants, intracerebral clips, implantable defibrillator, cerebral shunt or ventricular catheter, other foreign metal objects in the upper part of the body
  • Persons unable to adhere to abstinence from the use of drugs or alcohol the day or evening before experimental sessions
  • Women who are pregnant, breastfeeding, or have given birth in the last 6 months
  • For experiments using magnetoencephalography:
  • Persons with
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Neuroscience de Lyon INSERM

Bron, 69500, France

Location

Study Officials

  • Mathilde Bonnefond, PhD

    INSERM Rhône Alpes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 22, 2019

Study Start

November 25, 2019

Primary Completion

February 27, 2025

Study Completion

February 27, 2025

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations