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Official title A PET-MRI Study of Serotoninergic Brainstem Pathway in Patients With Dravet Syndrome
ClinicalTrials.gov ID: NCT07013331
What this study is testing
- What it's testing
- Dravet Syndrome (DS) is a severe neurodevelopmental disease, which is predominantly caused by mutations of SCN1A, the gene coding for Nav1.1 voltage-gated sodium channels. DS is characterized by infancy onset, severe cognitive deficit and drug-resistant seizures, including several generalized convulsive seizures per day and frequent status epilepticus, often triggered by fever or hyperthermia.
- Time commitment: about 18 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Patients with DS
- 1. Adult patients (≥ 18 but \< 60 years)
- 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 assent and patient (or patient's legal representative guardianship) who gave its written informed consent to participate to the study
You likely can't join if
- Subject in exclusion period of another study
- MRI contra-indication (presence of metallic elements, claustrophobia, Patients unable to maintain a minimul level of immobility during the imaging...
- Presence of Vagal Nerve Stimulation
- Patients unable to maintain a minimul level of immobility during the imaging acquisition
- Pregnant women, women in labor or breastfeeding women.
- Severe renal failure (Glomerular filtration rate \< 30 ml/min)
See the full eligibility criteria
- Patients with DS
- 1. Adult patients (≥ 18 but \< 60 years)
- 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 assent and patient (or patient's legal representative guardianship) who gave its written informed consent to participate to the study
- For women of childbearing
- Subject in exclusion period of another study
- MRI contra-indication (presence of metallic elements, claustrophobia, Patients unable to maintain a minimul level of immobility during the imaging acquisition)
- Presence of Vagal Nerve Stimulation
- Patients unable to maintain a minimul level of immobility during the imaging acquisition
- Pregnant women, women in labor or breastfeeding women.
- Severe renal failure (Glomerular filtration rate \< 30 ml/min)
- Hypersensitivity to [18F] MPPF
- Persons deprived of their liberty by a judicial or administrative decision
- Persons under psychiatric care
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme Patients with drug-resistant focal epilepsy
- Inclusion criteria
- Adult patient (≥ 18 years)
- Patient suffering from drug-resistant focal epilepsy according to ILAE classification
- Patient in whom presurgical evaluation is considered
- No restriction related to the seizure frequency
- Patient who gave her/his written informed consent to participate to the study
- For women of childbearing potential, use highly effective contraception during study participation
- Exclusion criteria
- Subject in exclusion period of another study
- MRI contra-indication (presence of metallic elements, claustrophobia)
- Presence of Vagal Nerve Stimulation
- Ongoing serotoninergic treatment, including selective serotonin reuptake inhibitor
- Pregnant women, women in labor or breastfeeding women.
- Severe renal failure (Glomerular filtration rate \< 30 ml/min)
- Hypersensitivity to [18F] MPPF
- Persons deprived of their liberty by a judicial or administrative decision
- Persons under psychiatric care
- Persons admitted to a health or social institution for purposes other than research
- Adults subject to a legal protection measure (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme Healthy controls
- Inclusion criteria
- 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)
- Pregnant women, women in labor or breastfeeding women.
- Severe renal failure (Glomerular filtration rate \< 30 ml/min)
- Hypersensitivity to [18F] MPPF
- Persons deprived of their liberty by a judicial or administrative decision
- Persons under psychiatric care
- Persons admitted to a health or social institution for purposes other than research
- Adults subject to a legal protection measure (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Exclusion criteria
- 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)
- Pregnant women, women in labor or breastfeeding women.
- Severe renal failure (Glomerular filtration rate \< 30 ml/min)
- Hypersensitivity to [18F] MPPF
- Persons deprived of their liberty by a judicial or administrative decision
- Persons under psychiatric care
- Persons admitted to a health or social institution for purposes other than research
- Adults subject to a legal protection measure (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
The study team makes the final eligibility decision.
Where it's taking place
- Bron, Rhone, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, Rhone, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.