跳至主要内容
临床试验/NCT00952601
NCT00952601终止1 期

Pilot Study of the Modified Atkins Diet for Tourette Syndrome

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年9月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (2)

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