Lymphocyte CpG methylation changes and brain pathology in Restless Legs Syndrome

这是一份行政补充拨款申请，请求为第四个项目提供补充财政支持 NIH 正在进行的拨款 R01-NS 101283 的年份。在最初资助的拨款申请中，我们计划 通过一家血液学诊所进行招募，预计每年筛选约 250 名受试者 预计将有 60 名受试者全部参加该研究。根据这些估计，我们预计 在资助的前 4 年完成必要的 240 个科目（120 个 RLS 和 120 个控制）。然而， 通过单一血液学诊所进行的招募未能提供足够的受试者注册。我们解决了 通过开展广泛的基础广泛的招聘工作来解决这个问题，包括： 以及涉及的诊所类型、在当地医院和大学张贴传单和海报、基于网络 和电视广告。通过更广泛的招聘工作，我们已经证明我们 可以提高招募率，但我们认为这足以达到适当的样本量 这可能需要继续招募到赠款的第五年。增加招聘 临床环境之外的患者增加了所需筛查实验室的数量，从而增加了成本。 最初的拨款申请中没有预见到这一点。广告和实验室筛选的成本一直是 原项目范围内未预期但必要的费用。我们要求增加成本 这笔补充赠款旨在保持项目的总体影响与其最初批准的一致 目标和目的。

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.