2025-524199-40-00招募中2 期
A PET-MRI study of serotoninergic brainstem pathway in patients with Dravet Syndrome - DRAPETONINE
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of the brainstem BPND of [18F]-MPPF across patients groups (DS and focal epilepsy)
研究概览
简要总结
Comparing the [18F]-MPPF PET brainstem regional distribution of 5HT1A receptors in patients with DS with the one of patients with drug-resistant focal epilepsy
研究设计
- 分配方式
- Not Applicable
- 主要目的
- [18f]mppf
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients with Dravet Syndrome: Adult patients (≥ 18 but < 60 years)
- •Patients with drug-resistant focal epilepsy: Patient who gave her/his written informed consent to participate to the study
- •Patients with drug-resistant focal epilepsy: For women of childbearing potential, use highly effective contraception during study participation
- •Healthy controls: Adult (≥ 18 years < 50 years)
- •Healthy controls: Without history of neurological disorders, and/or general medical disorders
- •Healthy controls: Subject who gave her/his written informed consent to participate to the study
- •Healthy controls: For women of childbearing potential, use highly effective contraception during study participation
- •Patients with Dravet Syndrome: 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
- •Patients with Dravet Syndrome: No restriction related to the seizure frequency
- •Patients with Dravet Syndrome: Patient assent and patient (or patient’s legal representative guardianship) who gave its written informed consent to participate to the study
- •Patients with Dravet Syndrome: For women of childbearing potential, use highly effective contraception during study participation.
- •Patients with drug-resistant focal epilepsy: Adult patient (≥ 18 years)
- •Patients with drug-resistant focal epilepsy: Patient suffering from drug-resistant focal epilepsy according to ILAE classification
- •Patients with drug-resistant focal epilepsy: Patient in whom presurgical evaluation is considered
- •Patients with drug-resistant focal epilepsy: No restriction related to the seizure frequency
排除标准
- •Patients with Dravet Syndrome: Subject in exclusion period of another study
- •Patients with Dravet Syndrome: Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- •Patients with drug-resistant focal epilepsy: Subject in exclusion period of another study
- •Patients with drug-resistant focal epilepsy: MRI contra-indication (presence of metallic elements, claustrophobia)
- •Patients with drug-resistant focal epilepsy: Presence of Vagal Nerve Stimulation
- •Patients with drug-resistant focal epilepsy: Ongoing serotoninergic treatment, including selective serotonin reuptake inhibitor
- •Patients with drug-resistant focal epilepsy: Pregnant women, women in labor or breastfeeding women.
- •Patients with drug-resistant focal epilepsy: Severe renal failure (Glomerular filtration rate < 30 ml/min)
- •Patients with drug-resistant focal epilepsy: Hypersensitivity to [18F] MPPF
- •Patients with drug-resistant focal epilepsy: Persons deprived of their liberty by a judicial or administrative decision
- •Patients with drug-resistant focal epilepsy: Persons under psychiatric care
- •Patients with Dravet Syndrome: MRI contra-indication (presence of metallic elements, claustrophobia, Patients unable to maintain a minimul level of immobility during the imaging acquisition)
- •Patients with drug-resistant focal epilepsy: Persons admitted to a health or social institution for purposes other than research
- •Patients with drug-resistant focal epilepsy: Adults subject to a legal protection measure (guardianship, curatorship)
- •Patients with drug-resistant focal epilepsy: Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- •Healthy controls: 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)
- •Healthy controls: Ongoing treatment with selective serotonin reuptake inhibitor
- •Healthy controls: MRI contra-indication (presence of metallic elements, claustrophobia)
- •Healthy controls: Pregnant women, women in labor or breastfeeding women.
- •Healthy controls: Severe renal failure (Glomerular filtration rate < 30 ml/min)
- •Healthy controls: Hypersensitivity to [18F] MPPF
- •Healthy controls: Persons deprived of their liberty by a judicial or administrative decision
- •Patients with Dravet Syndrome: Presence of Vagal Nerve Stimulation
- •Healthy controls: Persons under psychiatric care
- •Healthy controls: Persons admitted to a health or social institution for purposes other than research
- •Healthy controls: Adults subject to a legal protection measure (guardianship, curatorship)
- •Healthy controls: Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- •Patients with Dravet Syndrome: Patients unable to maintain a minimul level of immobility during the imaging acquisition
- •Patients with Dravet Syndrome: Pregnant women, women in labor or breastfeeding women.
- •Patients with Dravet Syndrome: Severe renal failure (Glomerular filtration rate < 30 ml/min)
- •Patients with Dravet Syndrome: Hypersensitivity to [18F] MPPF
- •Patients with Dravet Syndrome: Persons deprived of their liberty by a judicial or administrative decision
- •Patients with Dravet Syndrome: Persons under psychiatric care
结局指标
主要结局
Comparison of the brainstem BPND of [18F]-MPPF across patients groups (DS and focal epilepsy)
Comparison of the brainstem BPND of [18F]-MPPF across patients groups (DS and focal epilepsy)
次要结局
- Comparison of the brainstem BPND of [18F]-MPPF of each patients group (DS and focal epilepsy) with the one of healthy subjects
- Comparison of the cortical BPND of [18F]-MPPF across patients groups (DS and focal epilepsy) and with the one of healthy subjects
- aluating the relation between [18F]-MPPF PET brainstem regional distribution of 5HT1A receptors and inter-ictal respiratory function in patients with DS
- Comparing brainstem regional volumes on MRI of patients with DS with the one of patients with drug-resistant focal epilepsy
- Comparing brainstem regional volumes on MRI of each patients group (DS and focal epilepsy) with the one of healthy subjects
- Evaluating the relation between the brainstem regional volumes on MRI and inter-ictal respiratory function in patients with DS
研究者
Pr Sylvain RHEIMS
Scientific
Hospices Civils De Lyon
研究点 (1)
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