EpilepsyNCT06974305
PET/MRI/EEG Imaging Study in Epilepsy
An observational study of Epilepsy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study aims to better understand how epilepsy alters brain function through neuroimaging of healthy people and people with epilepsy. The study investigates how changes in brain metabolism (sugar consumption, measured by positron emission tomography [FDG-PET], and blood flow, measured by functional magnetic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- FDG-PET/fMRI/EEG imaging
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Study populations are healthy people and people with epilepsy.
Who may be able to join
- Age 18 or older
- Additional Inclusion Criteria for Subjects with Epilepsy:
- Diagnosed with epilepsy with abnormal interictal EEG
Who cannot join
- Contraindications to PET, MRI, or EEG imaging
- History of severe brain disease such as stroke and head trauma
- History of brain surgery
- History of type I or II diabetes mellitus
- Fasting plasma glucose level >200 mg/dL
- Employed under direct supervision of the PI conducting the research
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- Additional Exclusion Criteria for Healthy Subjects:
- Current use of drugs that modulate brain function
- Current or past history of major medical, neurological, or psychiatric conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Athinoula A. Martinos Center
Charlestown, Massachusetts, 02129
Ciprian Catana
About this study
Official title: Investigation of Interictal Metabolic and Electrophysiologic Changes in Epilepsy Through Trimodal Neuroimaging
This study aims to better understand how epilepsy alters brain function through neuroimaging of healthy people and people with epilepsy. The study investigates how changes in brain metabolism (sugar consumption, measured by positron emission tomography [FDG-PET], and blood flow, measured by functional magnetic resonance imaging [fMRI]) relate to abnormal interictal electrical activity associated with epilepsy (measured by electroencephalography [EEG]). The study will also compare how the three imaging modalities localize regions of abnormal function in the brain.
- Conditions
- Epilepsy
- Being tested
- FDG-PET/fMRI/EEG imaging
- Keywords
- Functional PET, FDG-PET, Functional MRI, EEG, Epilepsy, Neuroimaging, Multimodal imaging
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PET/fMRI/EEG imagingRadiation
Subject will undergo simultaneous EEG, fMRI, and FDG-PET imaging. This includes the use of a standard injected radioactive marker used in PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy control subjects with no major medical history Receives: Radiation: FDG-PET/fMRI/EEG imaging | |
| Subjects with Epilepsy | Subjects diagnosed with epilepsy and with abnormal electrical activity recorded on interictal EEG. Receives: Radiation: FDG-PET/fMRI/EEG imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image analysis
There are no interventions in this study and thus no outcome measures. Primary goal of the study will be achieved with image analysis on the PET/MRI/EEG data.
Measured: Image analysis to be performed after imaging sessions are complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start21 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciprian Catana, MD, PhD, Massachusetts General Hospital
- Investigators
- Ciprian Catana, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974305
- Sponsor's protocol ID
- 2022P000929
- Status last verified
- May 2025
- First submitted
- 12 Mar 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Interictal Metabolic and Electrophysiologic Changes in Epilepsy Through Trimodal Neuroimaging
- ClinicalTrials.gov ID
- NCT06974305
- Acronym / sponsor ID
- 2022P000929
- Conditions
- Epilepsy
- Keywords
- Functional PET, FDG-PET, Functional MRI, EEG, Epilepsy, Neuroimaging, Multimodal imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 May 2025 (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.
This study aims to better understand how epilepsy alters brain function through neuroimaging of healthy people and people with epilepsy. The study investigates how changes in brain metabolism (sugar consumption, measured by positron emission tomography [FDG-PET], and blood flow, measured by functional magnetic resonance imaging [fMRI]) relate to abnormal interictal electrical activity associated with epilepsy (measured by electroencephalography [EEG]). The study will also compare how the three imaging modalities localize regions of abnormal function in the brain.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Radiation: FDG-PET/fMRI/EEG imagingHealthy control subjects with no major medical history |
| Subjects with Epilepsy | – | Radiation: FDG-PET/fMRI/EEG imagingSubjects diagnosed with epilepsy and with abnormal electrical activity recorded on interictal EEG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study populations are healthy people and people with epilepsy.
Key inclusion criteria (3 listed)
- Age 18 or older
- Diagnosed with epilepsy with abnormal interictal EEG
Key exclusion criteria (9 listed)
- Contraindications to PET, MRI, or EEG imaging
- History of severe brain disease such as stroke and head trauma
- History of brain surgery
- History of type I or II diabetes mellitus
- Fasting plasma glucose level >200 mg/dL
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 |
|---|---|---|
| FDG-PET/fMRI/EEG imagingSubject will undergo simultaneous EEG, fMRI, and FDG-PET imaging. This includes the use of a standard injected radioactive marker used in PET imaging. | Radiation | Healthy Controls, Subjects with Epilepsy |
Primary outcome
Image analysis
Time frame: Image analysis to be performed after imaging sessions are complete.
There are no interventions in this study and thus no outcome measures. Primary goal of the study will be achieved with image analysis on the PET/MRI/EEG data.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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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.
Ciprian Catana, MD, PhD principal investigator
Massachusetts General Hospital
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 Epilepsy, run by Massachusetts General Hospital at 1 site in United States.
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 9 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magdelena S Allen, BA (617-724-9232, mallen27@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image analysis (time frame: Image analysis to be performed after imaging sessions are complete.). 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 23 Apr 2026.