Tracking Information Flow in the Brain (BRAINDYN)
Tracking Information Flow in the Brain: A Unified and General Framework for Dynamic Communication in Brain Networks
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Mathilde Bonnefond, PhD
- Phone Number: 33 4 72 13 89 03
- Email: mathilde.bonnefond@inserm.fr
Study Contact Backup
- Name: Anne Kösem, PhD
- Phone Number: 33 4 72 13 89 03
- Email: anne.kosem@inserm.fr
Study Locations
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Bron, France, 69500
- Centre de Recherche en Neuroscience de Lyon INSERM
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 20-36 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
Exclusion Criteria:
- 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
- claustrophobia
- any dental apparatus containing metal including or root canals
- any foreign metallic object anywhere in the body
- bolts, screws
- orthopedic devices or implants
- glasses (given the participant cannot use contact lenses)
- a head size incompatible with the use of a personalized 3D head-cast or a magnetoencephalograph
- Persons having had any surgery prior to the study which puts them at risk for metal objects left in the body
For experiments using Magnetic Resonance Imaging (MRI) or Functional Magnetic Resonance Imaging (fMRI) techniques:
- Anxious, non-cooperative, or agitated persons
- Claustrophobia
- Persons having had any surgery prior to the study which puts them at risk for metal objects left in the body
For experiments using transcranial stimulation:
-Persons with frequent syncope episodes (loss of consciousness) as a result of any particular sensorial stimulations
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Main study group
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.
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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
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The composite characteristics of the brain oscillations (frequency, synchronization, and interaction between brain oscillations in and between different brain regions and networks)
Time Frame: up to 17 months
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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.
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up to 17 months
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The coupling of behavioral responses to stimuli with physiological responses in the brain.
Time Frame: up to 17 months
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Throughout the sessions of neuroimaging.
There are 5, 1 or 2, and 1 sessions of neuroimaging for experiment 1, 2, and 3 respectively.
The 5 sessions of experiment 1 are over a period of 1 to 17 months.
Each session lasts approximately 3 hours including setup.The sessions take place at between 7 and 198 days after inclusion.
The time between the sessions is variable.
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up to 17 months
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Coupling of brain oscillation characteristics in responses to the "flickering" effect
Time Frame: up to 17 months
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There are 5 sessions of neuroimaging for experiment 1.
The 5 sessions of experiment 1 are over a period of 1 to 17 months.
Each session lasts approximately hours including setup.
This outcome measure will be recorded during these 5 interspaced sessions, at between 7 and 198 days after inclusion.
The time between the sessions is variable.
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up to 17 months
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Mathilde Bonnefond, PhD, INSERM Rhône Alpes
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- 69HCL18_0854
- 2019-A01604-53 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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