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

Launched by HOSPICES CIVILS DE LYON · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial, called the DRAPETOTINE study, is investigating the brain pathways related to serotonin in patients with Dravet Syndrome (DS), a severe form of epilepsy that often leads to frequent and hard-to-treat seizures. Researchers believe that problems with serotonin may play a role in the breathing difficulties seen in people with epilepsy, which can lead to serious outcomes like sudden unexpected death in epilepsy (SUDEP). The study will use advanced imaging techniques, PET and MRI scans, to see if there are specific changes in the serotonin pathways of the brain in adults with DS compared to those with other types of drug-resistant epilepsy and healthy individuals.

To participate in this study, adults aged 18 to 59 with a confirmed diagnosis of Dravet Syndrome or those with drug-resistant focal epilepsy may be eligible, as well as healthy adults without any neurological or psychiatric disorders. Participants will be asked to undergo imaging over a period of 2 to 8 weeks, during which they will contribute to important research that could help improve understanding and treatment of epilepsy. It’s important to note that those with certain medical conditions or treatments may not qualify, and participants will need to provide informed consent and understand the study details.

Gender

ALL

Eligibility criteria

• • Patients with DS
• • Inclusion criteria
• • Adult patients (≥ 18 but \< 60 years) with established diagnosis of Dravet Syndrome
• • Adults protected by a guardianship or curatorship
• • Diagnosis of Dravet syndrome will be confirmed based on medical history, type of seizures, EEG data and results of genetic testing
• • No restriction related to the seizure frequency
• • Patient (or patient's legal representative) who gave its written informed consent to participate to the study
• • Patient and/or Legal representative understanding and speaking national language
• • Absence of known current pregnancy and breastfeeding
• • Patient affiliated to the French national health care system
• • Exclusion criteria
• • Subject in exclusion period of another study
• • MRI contra-indication (presence of metallic elements)
• • Presence of Vagal Nerve Stimulation
• • Claustrophobia
• • Patients unable to maintain a minimul level of immobility during the imaging acquisition
• • Patients with drug-resistant focal epilepsy
• • Inclusion criteria
• • Adult patient (≥ 18 years) suffering from drug-resistant focal epilepsy according to ILAE classification
• • Patients in whom presurgical evaluation is considered
• • Patient who gave her/his written informed consent to participate to the study
• • No restriction related to the seizure frequency
• • Absence of known current pregnancy and breastfeeding
• • Patient affiliated to French health care system
• • Exclusion criteria
• • Subject in exclusion period of another study
• • Adults protected by a guardianship or curatorship
• • MRI contra-indication (presence of metallic elements)
• • Presence of Vagal Nerve Stimulation
• • Claustrophobia
• • Ongoing serotoninergic treatment, including selective serotonin reuptake inhibitor
• • Healthy controls
• • Inclusion criteria
• • Adult (≥ 18 years)
• • Without history of neurological disorders and/or psychiatric disorders, and/or general medical disorders
• • Subject who gave her/his written informed consent to participate to the study
• • Subject affiliated to the French health care system
• • Absence of known current pregnancy and breastfeeding
• • Exclusion criteria
• • Age \< 18 years
• • 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)
• • Ongoing treatment with selective serotonin reuptake inhibitor
• • MRI contra-indication (presence of metallic elements)
• • Claustrophobia