Ketogenic Diet Effects on the Frequency of Non Epileptic Seizures in Patients With Dissociative Neurological Symptom Disorder: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- non epileptic seizure frequency
研究概览
简要总结
The objective of this study is to determine the effects of the ketogenic diet on the frequency of non-epileptic seizures in patients with functional neurological symptoms disorder compared to a healthy diet.
详细描述
This study consists of a open label randomized controlled clinical trial comprised of 20 patients with diagnosis of functional neurological symptom disorder with non epileptic seizures distributed in 2 arms of 10 patients each.
Patients will be randomly assigned to one of the groups. Both groups will be receiving treatment as usual (SSRI and/or psychotherapy). One group will be assigned a ketogenic diet while the other will be assigned a healthy diet, both supervised by a team of nutritionists. Patients will be evaluated every 2 weeks until reaching 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have a record at the institute and who have a diagnosis of a dissociative neurological symptom disorder with non-epileptic seizures with a certainty of at least clinically established who have a monthly seizure frequency greater than
- •Patients with the characteristics described above with comorbid epilepsy but who have not presented epileptic seizures in the last month.
- •Patients with the aforementioned characteristics and who give their informed consent in writing to participate in the study.
- •Patients who, once the diet has been explained to them, consider it feasible to implement it at least for the follow-up time.
排除标准
- •Patients with metabolic or hemodynamic instability, liver failure, inability to tolerate the oral route, acute pancreatitis or pregnancy due to the possible teratogenic effect that has not yet been elucidated.
- •Patients with metabolic disorders such as primary carnitine deficiency, palmitoyltransferase carnitine I or II deficiency, carnitine translocase deficiency, beta oxidation defects, pyruvate carboxylase deficiency, porphyria and other fatty acid transport and oxidation disorders.
结局指标
主要结局
non epileptic seizure frequency
时间窗: 2 weeks
number of non epileptic seizures the patient reports on a written crisis record with the aid of a caregiver if necessary
次要结局
未报告次要终点
研究者
Edgar Daniel Crail Melendez
MS
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez