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

Recruiting

• Conditions: Psychosis; Epilepsy; Healthy; Essential Tremor
• Interventions: Device: Structural MRI at 7 Tesla; Device: Simultaneous EEG-fMRI at 7 Tesla

• Registration Number: NCT05769933
• Lead Sponsor: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-21
• Study First Submitted: 2023-02-22
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Study First Posted: 2023-03-15
• Last Update Posted: 2023-03-15
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Essential tremor patients	Structural MRI at 7 Tesla	Non-hospitalized volunteers who have been diagnosed with essential tremor and are indicated for thalamic surgery. Interventions: MRI.
Healthy controls	Simultaneous EEG-fMRI at 7 Tesla	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.
Epilepsy patients	Simultaneous EEG-fMRI at 7 Tesla	Non-hospitalized volunteers who have been diagnosed with epilepsy.
Healthy participants	Structural MRI at 7 Tesla	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.
Psychosis patients	Simultaneous EEG-fMRI at 7 Tesla	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.
Psychosis patients	Structural MRI at 7 Tesla	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.
Healthy participants	Simultaneous EEG-fMRI at 7 Tesla	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.
Healthy controls	Structural MRI at 7 Tesla	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.
Epilepsy patients	Structural MRI at 7 Tesla	Non-hospitalized volunteers who have been diagnosed with epilepsy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Neuroimaging datasets published in fully anonymized form in suitable public data repositories	Day 1

Trial Locations

Locations (1)

TIC - Translational Imaging Center; 🇨🇭 Bern, Switzerland