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

NCT05769933 | Unknown

• 2 other identifiers: 221-FP.2333_PUZZLESNCTP000005245
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Epilepsy; Psychosis; Essential Tremor

Keywords

electroencephalography; magnetic resonance imaging; ultra-high field; neuroimaging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Neuroimaging datasets published in fully anonymized form in suitable public data repositories

  Day 1

Study Arms (5)

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; Device: Structural MRI at 7 Tesla

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

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; Device: Structural MRI at 7 Tesla

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; Device: Structural MRI at 7 Tesla

Epilepsy patients

Non-hospitalized volunteers who have been diagnosed with epilepsy.

Device: Simultaneous EEG-fMRI at 7 Tesla; Device: Structural MRI at 7 Tesla

Interventions

Simultaneous EEG-fMRI at 7 Tesla DEVICE

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.

Epilepsy patients; Healthy controls; Healthy participants; Psychosis patients

Structural MRI at 7 Tesla DEVICE

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; Essential tremor patients; Healthy controls; Healthy participants; Psychosis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy adult volunteers and adult patients without specific risk profiles.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

TIC - Translational Imaging Center

Bern, Switzerland

RECRUITING

MeSH Terms

Conditions

Epilepsy; Psychotic Disorders; Essential Tremor

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Movement Disorders

Central Study Contacts

João Jorge, PhD

CONTACT

+41 32 720 51 11; info@csem.ch

Study Design

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

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 15, 2023
• Study Start: September 21, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: With relevant publications
• Access Criteria: Publicly available (anonymized)

Locations

CH (1)