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临床试验/NCT05281445
NCT05281445Unknown不适用

Exploring the Role of Neuroactive Steroids in Tourette Syndrome

University of Utah2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
2
主要终点
Salivary allopregnanolone concentrations

研究概览

简要总结

Tourette syndrome (TS) is a disabling neurodevelopmental disorder characterized by motor and phonic tics. The studies proposed in this application will explore the endocrine mechanisms underlying two of the least well-understood biological characteristics of TS, namely its marked male predominance and stress susceptibility. In particular, our exploratory studies will characterize the steroid profile in TS-affected boys and girls to identify novel potential biomarkers and therapeutic targets for this disorder.

详细描述

Tourette syndrome (TS) is a disabling neurodevelopmental disorder characterized by motor and phonic tics. Available treatment strategies remain unsatisfactory, due to limited knowledge of the biological foundations of this disorder. The studies proposed in this application will explore the mechanisms underlying two of the least well-understood biological characteristics of TS, namely its marked male predominance and stress susceptibility. Studies from the investigators suggest that these features of TS are contributed by neuroactive steroids, a family of mediators implicated in sex and stress regulation.

The typical age of onset of TS is 6-7 years, coinciding with adrenarche, a phase of adrenal maturation characterized by an upsurge in adrenal neuroactive steroids, such as dehydroepiandrosterone (DHEA) and its sulfate (DHEAS). In preliminary studies, the investigators found that DHEA exacerbated tic-like responses in animal models of TS. Interestingly, the dose of DHEA needed to elicit TS-like responses in females is higher than those needed in males, possibly pointing to a mechanism of sex differences in TS.

Stress reduces the ability of TS patients to suppress tics, but the underlying mechanisms remain unknown. Studies in animal models indicate that this process may be due to the elevation of the neuroactive steroid allopregnanolone (AP) in the prefrontal cortex. By inhibiting the ability of the prefrontal cortex to suppress tics, AP promotes tic execution. In a pilot study, the investigators found that tic suppression, a well-known stressful task in TS patients, increases AP salivary levels. Furthermore, in another proof-of-concept study, the investigators found that inhibiting AP synthesis led to a reduction in tic severity and facilitated voluntary control of tics in stressful situations.

These findings lead to the hypothesis that TS patients exhibit alterations of the composition of their neuroactive steroid profiles, including: 1) an increase in baseline DHEA(S) levels in male TS patients, in correlation with life-time severity; and 2) an exaggerated elevation in AP in response to acute stress.

The two Aims of this proposal will test this hypothesis by: 1) comparing the baseline urinary steroidomic profile of TS-affected boys and girls with non-affected sex- and age-matched controls; and 2) charting the dynamic alterations in steroidomic salivary profiles in response to tic suppression. These studies will advance understanding of the endocrine mechanisms in TS and lead to the identification of potential biomarkers for the severity of tics and comorbid symptoms. In the long run, the results of these studies may open the way for the development of new therapies for TS that may reduce tic severity and increase patients' responsiveness to behavioral interventions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnostic criteria of TS for cases (and lack of any tic disorders for controls)
  • Age between 8 and 12 years old (this age range is to ensure that TS participants can perform the tic suppression task)
  • confirmation of sexual development by parent and/or self-reported Tanner stage of pubic hair development.

排除标准

  • major psychiatric disorders such as a psychotic disorder, autism spectrum disorder, conduct disorder, and substance use disorder;
  • other neurological disorders;
  • clinically significant endocrinological disorders;
  • use of therapies that can modify hormonal profile;
  • pharmacotherapies that may change stress sensitivity, such as antidepressants and anxiolytics.

结局指标

主要结局

Salivary allopregnanolone concentrations

时间窗: Through study completion, an average of 2 years

Change of concentrations of salivary allopregnanolone, as measured by chromatography/ mass spectrometry. All concentrations will be expressed in pg/ml.

次要结局

  • Tic frequency(Through study completion, an average of 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Bortolato

Associate Professor

University of Utah

研究点 (2)

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