HealthyNCT05769933
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
An observational study of Healthy and Epilepsy, run by CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Simultaneous EEG-fMRI at 7 Tesla and Structural MRI at 7 Tesla
- Type of treatment
- Medical device
- How many people
- 156 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Sep 2022to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers and adult patients without specific risk profiles.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
TIC - Translational Imaging Center
Bern
João Jorge
About this study
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
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
- Being tested
- Simultaneous EEG-fMRI at 7 Tesla, Structural MRI at 7 Tesla
- Keywords
- electroencephalography, magnetic resonance imaging, ultra-high field, neuroimaging
- Medical subject headings
- Epilepsy, Psychotic Disorders, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous EEG-fMRI at 7 TeslaDevice
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 TeslaDevice
Structural magnetic resonance imaging (MRI) at 7 Tesla. These will be completely non-invasive techniques with no ionizing radiation and no injected contrasts.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Simultaneous EEG-fMRI at 7 Tesla; Device: Structural MRI at 7 Tesla | |
| Epilepsy patients | Non-hospitalized volunteers who have been diagnosed with epilepsy. Receives: Device: Simultaneous EEG-fMRI at 7 Tesla; Device: Structural MRI at 7 Tesla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-to-noise ratio between thalamic nuclei in 7T structural MRI
Measured: Day 1
Pearson correlation between thalamocortical brain regions in 7T functional MRI
Measured: Day 1
Microstate duration in EEG acquired concurrently with 7T functional MRI
Measured: Day 1
Secondary outcomes (1)
Neuroimaging datasets published in fully anonymized form in suitable public data repositories
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start21 Sep 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute for Diagnostic and Interventional Neuroradiology, Inselspital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769933
- Sponsor's protocol ID
- 221-FP.2333_PUZZLE
- Other IDs
- SNCTP000005245
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Neuroimaging data from the study will be made publicly available in fully anonymized form.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05769933
- Acronym / sponsor ID
- 221-FP.2333_PUZZLE
- Conditions
- Healthy, Epilepsy, Psychosis, Essential Tremor
- Keywords
- electroencephalography, magnetic resonance imaging, ultra-high field, neuroimaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et DeveloppementIndustry (pharma, biotech, devices)
- Collaborators
- Institute for Diagnostic and Interventional Neuroradiology, Inselspital
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Device: Simultaneous EEG-fMRI at 7 Tesla, Device: Structural MRI at 7 TeslaHealthy 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. |
| Essential tremor patients | – | Device: Structural MRI at 7 TeslaNon-hospitalized volunteers who have been diagnosed with essential tremor and are indicated for thalamic surgery. Interventions: MRI. |
| Psychosis patients | – | Device: Simultaneous EEG-fMRI at 7 Tesla, Device: Structural MRI at 7 TeslaNon-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 controls | – | Device: Simultaneous EEG-fMRI at 7 Tesla, Device: Structural MRI at 7 TeslaHealthy 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 | – | Device: Simultaneous EEG-fMRI at 7 Tesla, Device: Structural MRI at 7 TeslaNon-hospitalized volunteers who have been diagnosed with epilepsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers and adult patients without specific risk profiles.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous EEG-fMRI at 7 TeslaScalp 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 | Epilepsy patients, Healthy controls, Healthy participants, Psychosis patients |
| Structural MRI at 7 TeslaStructural magnetic resonance imaging (MRI) at 7 Tesla. These will be completely non-invasive techniques with no ionizing radiation and no injected contrasts. | Device | Epilepsy patients, Essential tremor patients, Healthy controls, Healthy participants, Psychosis patients |
Primary outcome
Contrast-to-noise ratio between thalamic nuclei in 7T structural MRI
Time frame: Day 1
Pearson correlation between thalamocortical brain regions in 7T functional MRI
Time frame: Day 1
Microstate duration in EEG acquired concurrently with 7T functional MRI
Time frame: Day 1
1 secondary outcome
Neuroimaging datasets published in fully anonymized form in suitable public data repositories
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Yes. Neuroimaging data from the study will be made publicly available in fully anonymized form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Epilepsy, run by CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact João Jorge, PhD (+41 32 720 51 11, info@csem.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast-to-noise ratio between thalamic nuclei in 7T structural MRI (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.