New brain scans aim to uncover why dravet patients face higher sudden death risk
NCT ID NCT07013331
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study uses PET and MRI scans to look at serotonin pathways in the brainstem of adults with Dravet syndrome, a severe form of epilepsy. Researchers want to see if these pathways are different in Dravet patients compared to those with other drug-resistant epilepsy and healthy people. The goal is to better understand why Dravet syndrome carries a high risk of sudden unexpected death in epilepsy (SUDEP). The study involves 30 participants: 10 with Dravet syndrome, 10 with focal epilepsy, and 10 healthy volunteers.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpital Neurologique Pierre Wertheimer
RECRUITINGBron, Rhone, 69500, France
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