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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05769933
• Other study ID #: 221-FP.2333_PUZZLE
• Secondary ID: SNCTP000005245
• Status: Recruiting
• Start date: September 21, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2023
• Source: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
• Contact: João Jorge, PhD
• Phone: +41 32 720 51 11
• Email: info[@]csem.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Essential Tremor
• Healthy
• Mental Disorders
• Psychosis
• Psychotic Disorders
• Tremor

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	TIC - Translational Imaging Center	Bern

Sponsors (2)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast-to-noise ratio between thalamic nuclei in 7T structural MRI		Day 1
Primary	Pearson correlation between thalamocortical brain regions in 7T functional MRI		Day 1
Primary	Microstate duration in EEG acquired concurrently with 7T functional MRI		Day 1
Secondary	Neuroimaging datasets published in fully anonymized form in suitable public data repositories		Day 1