Lymphocyte CpG methylation changes and brain pathology in Restless Legs Syndrome

这是一份行政补充补助金申请，要求为第四届 美国国立卫生研究院（NIH）资助的一年，R 01-NS 101283。在最初的资助申请中，我们计划 通过单个血液学诊所招募，预计每年筛选约250例受试者， 估计有60名受试者将完全入组该研究。根据这些估计，我们预计 在补助金的前4年内达到必要的240个科目（120个RLS和120个对照）。然而，在这方面， 通过单一血液学诊所招募无法提供足够的受试者入组。我们解决 通过开展广泛的基础广泛的招聘工作，包括： 以及所涉及的诊所类型，在当地医院和学院张贴传单和海报， 和电视广告。通过更广泛的招聘努力，我们已经证明， 可以提高招聘率，我们认为这将足以实现适当的样本大小，虽然 可能需要在补助金的第五年继续征聘。增加征聘 临床环境之外的患者增加了所需的筛查实验室的数量，因此增加了成本。 这在最初的赠款申请中是没有预见到的。广告和实验室筛查的成本一直是 在原项目范围内的意外但必要的费用。我们要求增加成本 在此补充拨款，以保持项目的整体影响与其最初批准的一致， 目标和宗旨。

This is a Administrative Supplement grant submission requesting supplemental financial support for the fourth year of the ongoing NIH grant, R01-NS 101283. In the originally funded grant application, we had planned for recruitment through a single Hematology clinic with expectations to screen about 250 subjects per year from which an estimated 60 subjects would be fully enrolled in the study. Based on these estimates, we expected to achieve the necessary 240 subjects (120 RLS and 120 control) over the first 4 years of the grant. However, recruitment through a single Hematology clinic has failed to provide adequate subject enrollment. We addressed this problem by developing a wide range of broad-based recruitment endeavors including: increasing the number and types of clinics involved, placement of flyers and posters across local hospitals and colleges, web-based and television advertisement. With the broader range of recruitment endeavors, we have demonstrated that we can increase the rate of recruitments, which we feel will be sufficient to achieve appropriate sample size, though that may require continuation of the recruitment into the fifth year of the grant. The increased recruitment of patients outside the clinical setting has increased the number of screening labs required and therefore the cost. This was not foreseen in the original grant application. The cost of advertising and lab screening has been an unanticipated but necessary expense within the scope of the original project. We are requesting a cost increase in this supplemental grant to preserve the overall impact of the project consistent with its originally approved objectives and purposes.