Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging

Sponsor

CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05769933

Collaborator

Institute for Diagnostic and Interventional Neuroradiology, Inselspital (Other)

156

Enrollment

Location

23.3

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The human brain presents outstanding challenges to science and medicine. Brain function and structure span broad spatial scales (from single neurons to brain-wide networks) as well as temporal scales (from milliseconds to years). Currently, none of the tools available for studying the brain can fully capture its structure and function across these diverse scales - "the neuroimaging puzzle". This poses crucial limitations to understanding how the brain works, and how it is affected by numerous diseases.

The central goal of this project is to expand currently available tools for non-invasive human brain imaging, to bridge critical gaps in the neuroimaging puzzle. New methodologies will be developed, focused on ultra-high field magnetic resonance imaging (UHF MRI) and its combination with electroencephalography (EEG). New contrast mechanisms and technological advances enabled by UHF MRI and EEG will be explored to allow unprecedented views into the microstructure of brain regions like the thalamus, and to capture the activity of large-scale neuronal networks in the brain with high sensitivity, temporal and spatial specificity. These advances will be directly applied to address open questions in the diagnosis and treatment of essential tremor, and psychosis.

In general, improved brain imaging techniques are critical for a deeper understanding of how the brain works, and to detect and characterize diseases more effectively, thereby improving clinical management and leading to a healthier population. The non-invasive characterization and treatment of neurodegenerative diseases like tremor is particularly relevant to aging modern societies.

Condition or Disease	Intervention/Treatment	Phase
Healthy Epilepsy Psychosis Essential Tremor	Device: Simultaneous EEG-fMRI at 7 Tesla Device: Structural MRI at 7 Tesla

Study Design

Study Type:

Observational

Anticipated Enrollment :

156 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Fine-scale Mapping of Brain Anatomy and Function With Combined Electroencephalography and 7T Magnetic Resonance Imaging: a Single-center Study on Healthy Participants and on Tremor, Psychosis and Epilepsy Patients

Actual Study Start Date :

Sep 21, 2022

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Healthy participants Healthy volunteers with no history of neurological problems or mental disorders; normal vision or corrected-to-normal using contact lenses. Interventions: MRI and combined EEG-fMRI.	Device: Simultaneous EEG-fMRI at 7 Tesla Scalp electroencephalography (EEG) and functional magnetic resonance imaging (MRI) at 7 Tesla. These will be completely non-invasive techniques with no ionizing radiation and no injected contrasts. Device: Structural MRI at 7 Tesla Structural magnetic resonance imaging (MRI) at 7 Tesla. These will be completely non-invasive techniques with no ionizing radiation and no injected contrasts.
Essential tremor patients Non-hospitalized volunteers who have been diagnosed with essential tremor and are indicated for thalamic surgery. Interventions: MRI.	Device: Structural MRI at 7 Tesla Structural magnetic resonance imaging (MRI) at 7 Tesla. These will be completely non-invasive techniques with no ionizing radiation and no injected contrasts.
Psychosis patients Non-hospitalized volunteers who have been diagnosed with early psychosis, and clinically assessed; normal vision or corrected-to-normal using contact lenses. Interventions: MRI and combined EEG-fMRI.	Device: Simultaneous EEG-fMRI at 7 Tesla Scalp electroencephalography (EEG) and functional magnetic resonance imaging (MRI) at 7 Tesla. These will be completely non-invasive techniques with no ionizing radiation and no injected contrasts. Device: Structural MRI at 7 Tesla Structural magnetic resonance imaging (MRI) at 7 Tesla. These will be completely non-invasive techniques with no ionizing radiation and no injected contrasts.
Healthy controls Healthy volunteers who have been clinically assessed and determined to be suitable matched controls with respect to the psychosis group; normal vision or corrected-to-normal using contact lenses. Interventions: MRI and combined EEG-fMRI.	Device: Simultaneous EEG-fMRI at 7 Tesla Scalp electroencephalography (EEG) and functional magnetic resonance imaging (MRI) at 7 Tesla. These will be completely non-invasive techniques with no ionizing radiation and no injected contrasts. Device: Structural MRI at 7 Tesla Structural magnetic resonance imaging (MRI) at 7 Tesla. These will be completely non-invasive techniques with no ionizing radiation and no injected contrasts.
Epilepsy patients Non-hospitalized volunteers who have been diagnosed with epilepsy.	Device: Simultaneous EEG-fMRI at 7 Tesla Scalp electroencephalography (EEG) and functional magnetic resonance imaging (MRI) at 7 Tesla. These will be completely non-invasive techniques with no ionizing radiation and no injected contrasts. Device: Structural MRI at 7 Tesla Structural magnetic resonance imaging (MRI) at 7 Tesla. These will be completely non-invasive techniques with no ionizing radiation and no injected contrasts.

Outcome Measures

Primary Outcome Measures

Contrast-to-noise ratio between thalamic nuclei in 7T structural MRI [Day 1]
Pearson correlation between thalamocortical brain regions in 7T functional MRI [Day 1]
Microstate duration in EEG acquired concurrently with 7T functional MRI [Day 1]

Secondary Outcome Measures

Neuroimaging datasets published in fully anonymized form in suitable public data repositories [Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Common to all participant groups: be 18 years old or older; be able to understand instructions; be able to provide informed consent.
Specific to healthy participants: have no history of neurological or mental disorders; normal vision or corrected-to-normal using contact lenses.
Specific to the patient groups: not be hospitalized; having been diagnosed with tremor, epilepsy or psychosis and invited to participate by our team's clinicians; for some groups: normal vision or corrected-to-normal using contact lenses.

Exclusion Criteria:

Contra-indications for MRI (e.g. an implant that is not MRI-compatible), also including having claustrophobia or being pregnant.
Inability to follow the necessary tasks of the study (e.g. unable to lie on the scanner bed).
Having undergone brain surgeries in the past.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TIC - Translational Imaging Center	Bern		Switzerland

Sponsors and Collaborators

CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Institute for Diagnostic and Interventional Neuroradiology, Inselspital