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This study uses [18F]MPPF PET-MRI imaging to examine the serotoninergic pathway in the brainstem of patients with Dravet syndrome (a severe form of epilepsy). It is open to adults aged 18 and older whose Dravet syndrome diagnosis has been genetically confirmed, along with comparison groups. It is a study without an assigned phase and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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