Actively Recruiting
A PET-MRI Study of Serotoninergic Brainstem Pathway in Patients With Dravet Syndrome
Led by Hospices Civils de Lyon · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Dravet Syndrome (DS) is a severe neurodevelopmental disorder caused mostly by mutations in the SCN1A gene, leading to frequent, drug-resistant seizures, cognitive deficits, and a high risk of sudden unexpected death in epilepsy (SUDEP). SUDEP is a major cause of premature death in epilepsy patients and is linked to seizure frequency and brainstem dysfunction. This study aims to investigate serotonin (5HT) pathway alterations in the brainstem of adults with DS using PET and MRI imaging to better understand SUDEP mechanisms. The study will include 20 adult participants: 10 with confirmed Dravet Syndrome, 10 with drug-resistant focal epilepsy, and 10 healthy adults. All participants will undergo PET-MRI imaging with injection of the tracer [18F]-MPPF to assess the serotonin brainstem pathway. The imaging involves anatomical MRI scans followed by a 90-minute dynamic emission scan after tracer injection. Women of childbearing potential will have a pregnancy test before imaging. Participants will have one inclusion visit for eligibility review and clinical examination, followed by the PET-MRI scan scheduled within 2 to 8 weeks. Researchers will compare brainstem serotonin receptor binding between groups and relate imaging findings to central sleep apnea duration and brainstem volume. The study will measure the signal-to-noise ratio of 5-HT1A receptor binding in healthy controls and monitor safety throughout. Each participant's involvement lasts from 2 to 8 weeks.
CONDITIONS
Brief Title
A PET-MRI Study of Serotoninergic Brainstem Pathway in Patients With Dravet Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to under 60 years
- Confirmed diagnosis of Dravet Syndrome based on medical history, seizure type, EEG data, and genetic testing
- No restrictions on seizure frequency
- Patient assent and written informed consent from patient or legal guardian
- For women of childbearing potential, use highly effective contraception during participation (for focal epilepsy group)
You will not qualify if you...
- Participation in another study exclusion period
- Contraindications to MRI (metallic implants, claustrophobia)
- Presence of Vagal Nerve Stimulation device
- Inability to remain still during imaging
- Pregnant, in labor, or breastfeeding women
- Severe renal failure (glomerular filtration rate under 30 ml/min)
- Hypersensitivity to [18F] MPPF tracer
- Persons deprived of liberty by judicial or administrative decision
- Persons under psychiatric care
- Persons not affiliated with a social security scheme or similar
- For drug-resistant focal epilepsy: ongoing serotoninergic treatment including SSRIs
- Adults under legal protection measures (guardianship, curatorship)
- Persons admitted to health or social institutions for non-research purposes (focal epilepsy and healthy controls) - For healthy controls: presence of anxiety/depression symptoms or ongoing SSRI treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 8 weeks after screening
Participants undergo a PET-MRI scan involving anatomical imaging and a dynamic emission scan after injection of the tracer [18F]MPPF. Women of childbearing age have a urine pregnancy test before the scan.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Hôpital Neurologique Pierre Wertheimer
Bron, Rhone, France, 69500
Actively Recruiting
Research Team
S
Sylvain Rheims, Pr
C
Camille Giraudon, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here