PET‑MRI mapping of brainstem serotonin pathways in adults with Dravet syndrome
A PET-MRI Study of Serotoninergic Brainstem Pathway in Patients With Dravet Syndrome
This uses a PET‑MRI scan with the tracer [18F]MPPF to see if serotonin pathways in the brainstem differ in adults with Dravet syndrome compared with healthy controls.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron, Rhone) |
| Trial ID | NCT07013331 on ClinicalTrials.gov |
What this trial studies
This single‑center imaging study enrolls adults (18–59 years) with clinically and genetically confirmed Dravet syndrome alongside healthy control participants. Each participant undergoes a combined PET‑MRI session using the serotonin receptor tracer [18F]MPPF to visualize serotoninergic pathways in the brainstem and related structural MRI measures. Imaging data will be compared between groups and correlated with clinical features such as seizure frequency and known SUDEP risk factors. The study aims to map possible serotonin system alterations that could be linked to seizure severity and sudden unexpected death in epilepsy.
Who should consider this trial
Good fit: Adults aged 18–59 with a confirmed diagnosis of Dravet syndrome who can tolerate MRI/PET procedures and provide informed consent (or have a legal guardian provide consent).
Not a fit: Children, pregnant or breastfeeding women, people with MRI contraindications or implanted vagal nerve stimulators, those with severe renal failure, hypersensitivity to [18F]MPPF, or who cannot remain still during imaging are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could reveal serotonin‑related brain changes that help identify patients at higher SUDEP risk or suggest new targets for therapies to reduce seizures and sudden death.
How similar studies have performed: Prior PET, postmortem, and preclinical work have suggested serotonin system abnormalities in epilepsy and SUDEP, but targeted PET‑MRI mapping of the brainstem serotonin pathway specifically in adult Dravet syndrome is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients with DS * Inclusion criteria 1. Adult patients (≥ 18 but \< 60 years) 2. Diagnosis of Dravet syndrome will be confirmed based on medical history, type of seizures, EEG data and results of genetic testing 3. No restriction related to the seizure frequency 4. Patient assent and patient (or patient's legal representative guardianship) who gave its written informed consent to participate to the study 5. For women of childbearing * Exclusion criteria 1. Subject in exclusion period of another study 2. MRI contra-indication (presence of metallic elements, claustrophobia, Patients unable to maintain a minimul level of immobility during the imaging acquisition) 3. Presence of Vagal Nerve Stimulation 4. Patients unable to maintain a minimul level of immobility during the imaging acquisition 5. Pregnant women, women in labor or breastfeeding women. 6. Severe renal failure (Glomerular filtration rate \< 30 ml/min) 7. Hypersensitivity to \[18F\] MPPF 8. Persons deprived of their liberty by a judicial or administrative decision 9. Persons under psychiatric care 10. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme Patients with drug-resistant focal epilepsy * Inclusion criteria 1. Adult patient (≥ 18 years) 2. Patient suffering from drug-resistant focal epilepsy according to ILAE classification 3. Patient in whom presurgical evaluation is considered 4. No restriction related to the seizure frequency 5. Patient who gave her/his written informed consent to participate to the study 6. For women of childbearing potential, use highly effective contraception during study participation * Exclusion criteria 1. Subject in exclusion period of another study 2. MRI contra-indication (presence of metallic elements, claustrophobia) 3. Presence of Vagal Nerve Stimulation 4. Ongoing serotoninergic treatment, including selective serotonin reuptake inhibitor 5. Pregnant women, women in labor or breastfeeding women. 6. Severe renal failure (Glomerular filtration rate \< 30 ml/min) 7. Hypersensitivity to \[18F\] MPPF 8. Persons deprived of their liberty by a judicial or administrative decision 9. Persons under psychiatric care 10. Persons admitted to a health or social institution for purposes other than research 11. Adults subject to a legal protection measure (guardianship, curatorship) 12. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme Healthy controls * Inclusion criteria 1. Presence of the symptoms of anxiety and/or depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS) 2. Ongoing treatment with selective serotonin reuptake inhibitor 3. MRI contra-indication (presence of metallic elements, claustrophobia) 4. Pregnant women, women in labor or breastfeeding women. 5. Severe renal failure (Glomerular filtration rate \< 30 ml/min) 6. Hypersensitivity to \[18F\] MPPF 7. Persons deprived of their liberty by a judicial or administrative decision 8. Persons under psychiatric care 9. Persons admitted to a health or social institution for purposes other than research 10. Adults subject to a legal protection measure (guardianship, curatorship) 11. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme * Exclusion criteria 1. Presence of the symptoms of anxiety and/or depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS) 2. Ongoing treatment with selective serotonin reuptake inhibitor 3. MRI contra-indication (presence of metallic elements, claustrophobia) 4. Pregnant women, women in labor or breastfeeding women. 5. Severe renal failure (Glomerular filtration rate \< 30 ml/min) 6. Hypersensitivity to \[18F\] MPPF 7. Persons deprived of their liberty by a judicial or administrative decision 8. Persons under psychiatric care 9. Persons admitted to a health or social institution for purposes other than research 10. Adults subject to a legal protection measure (guardianship, curatorship) 11. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Where this trial is running
Bron, Rhone
- Hôpital Neurologique Pierre Wertheimer — Bron, Rhone, France (Recruiting)
Study contacts
- Study coordinator: Sylvain Rheims, Pr
- Email: Sylvain.rheims@chu-lyon.fr
- Phone: 0472357106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.