Evaluation Via PET Scan of Metabolic Anomolies Associated With the 6 Month Clinical Evolution of Patients Suffering From Motor Conversion Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Presence/absence of a modified Ranking score > 1
研究概览
简要总结
The main objective of this study is to make a first evaluation of the relationship between metabolic abnormalities objectified by Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography (PET CT 18 FDH) performed at rest at the onset of symptoms in patients with a first episode of motor conversion disorder and the persistence of a motor disability at 6 months measured by the modified Rankin score (mRS).
详细描述
The secondary objectives of this study are:
A. To assess whether metabolic abnormalities objectified by PET CT 18 FDH performed at rest at the onset of symptoms may be predictive of persistent disability at 6 months as measured by the EDSS, the NIHSS and WHO status.
B. To assess whether metabolic abnormalities objectified by PET CT 18 FDH performed at rest at 3 months after diagnosis may be predictive of persistent motor disability at 6 months (EDSS, NIHSS, mRS, WHO) C. To search for and characterize any abnormalities of metabolism objectified in the initial PET CT 18 FDH predictive of persistent motor disability at 3 months.
D. To determine if there are persistent metabolic abnormalities 3 months post-diagnosis independently of the clinical course (marker trait).
E. Define the brain areas whose metabolism is often altered in patients with motor conversion disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given free and informed consent and signed the consent
- •The patient must be affiliated with or beneficiary of a health insurance plan
- •The patient meets DSM-IV criteria for motor conversion disorder (with paralysis, motor weakness or abnormal movements) lasting for less than 1 month and euthymic (HAMD score < or = 7, as evaluated by a psychiatrist)
- •First episode (incident cases)
- •The latest symptom dates to within a month
- •The patient is not under neuroleptics
排除标准
- •The subject is participating in another study
- •The subject is in an exclusion period determined by a previous study
- •The subject is under judicial protection, guardianship or curatorship
- •The subject refuses to sign the consent
- •It is not possible to correctly inform the patient
- •The patient is pregnant, parturient or she is breastfeeding
- •Specialized clinical neurological examination and brain and spinal cord MRI revealed an organic neurological cause
- •The subject has a HAMD score > 7
- •The subject currently has manic/hypomanic episode, a diagnosis of substance abuse or dependency (excluding tobacco), a diagnosis of schizophrenia (any time in the past) or chronic neurological disease (active epilepsy, stroke, brain tumor)
- •Suicidal or high risk for suicide (according to MINI assessment)
- •Contra-indication for a PET scan
- •Patient under neuroleptics at inclusion
- •The last symptom happened over 1 month ago
- •The patient has had previous episodes (prevalent cases)
结局指标
主要结局
Presence/absence of a modified Ranking score > 1
时间窗: 6 months
Presence/absence of a metabolic anomoly according to PET CT 18 FDG
时间窗: Day 0 to Day 15
PET CT 18 FDG = Positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro- D-glucose integrated with computed tomography
次要结局
- Presence/absence of a metabolic anomoly according to PET CT 18 FDG(3 months)
- HAMD scale(6 months)
- NIHSS score(6 months)
- HADS scale(6 months)
- WHO score(6 months)
- Modified Rankin Score(6 months)
- EDSS score(6 months)
- MINI questionnaire(Day 0 to Day 15)