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Clinical trial Recruiting at 1 site Interventional Ages 18 to 60

PET‑MRI mapping of brainstem serotonin pathways in adults with Dravet syndrome

Official title: A PET-MRI Study of Serotoninergic Brainstem Pathway in Patients With Dravet Syndrome

Run by Hospices Civils de Lyon · NCT07013331 · Data updated 2026-11-12

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.

More Epilepsy trials

Quick facts

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment30 (estimated)
SponsorHospices Civils de Lyon
Academic / other
Locations1 site (Bron, Rhone)
StatusRecruiting
StartedMay 4, 2026
Main results expectedJanuary 4, 2028
Study endsJanuary 4, 2028
Registry record updatedMay 8, 2026
Trial IDNCT07013331 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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).

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Hôpital Neurologique Pierre Wertheimer
    Bron, Rhone, France     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Epilepsy 491Dravet Syndrome 9Drug Resistant Epilepsy 40Healthy Controls 26Hospices Civils de Lyon 264
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.