Pilot Study of the Modified Atkins Diet for Tourette Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Tic frequency
研究概览
简要总结
Pharmacotherapy has long been considered the primary approach for tic suppression in Tourette syndrome (TS). Unfortunately, medications are often ineffective and frequently have significant side-effects. This is a pilot therapeutic study using a dietary approach, the modified Atkins diet (MAD). The goal of this study is to establish the safety, tolerability, and efficacy of dietary therapy in patients with TS ("proof of concept") and to determine whether this intervention is worthy of evaluation in large-scale clinical trials. The modified Atkins diet mimics the well established ketogenic diet, but in a less-restrictive dietary manner. Dietary approaches using the MAD/ketogenic diet are currently under investigation for neurological conditions other than epilepsy, including Alzheimer disease, headaches, autism, narcolepsy, brain tumors, traumatic brain injury, Parkinson's disease, and depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 12-65 years
- •Tourette syndrome (vocal and motor tics for over a year)
- •> 20 score on the Yale Global Tic Severity Scale
- •Ability to follow instructions and comply with the dietary changes
排除标准
- •Secondary tics
- •Underweight (BMI < 5%)
- •Prior use of the Atkins diet for over 2 days
- •High cholesterol or triglycerides
- •Major depression or anxiety disorder
- •Pregnancy
- •Substance abuse
结局指标
主要结局
Tic frequency
时间窗: 2 months
Number of tics per day, intensity, severity, will be compared to baseline (pre-diet)
次要结局
- Ketosis(2 months)
