Shevorykin Alina, Carl Ellen, Liskiewicz Amylynn, Hanlon Colleen A, Bickel Warren K, Mahoney Martin C, Vantucci Darian, Bensch Lindsey, Thorner Hannah, Marion Matthew, Sheffer Christine E
Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States.
Department of Cancer Biology, Wake Forest School of Medicine, Winston-Salem, NC, United States.
Front Rehabil Sci. 2023 Mar 3;4:1054456. doi: 10.3389/fresc.2023.1054456. eCollection 2023.
Translating repetitive transcranial magnetic stimulation (rTMS) into evidence-based clinical applications relies on research volunteers with different perspectives on the burden of study participation. Additionally, clinical applications of rTMS require multiple visits over weeks or months, the impact of research burden is an important component for these studies and translation of these findings to clinical practice. High frequency rTMS has significant potential to be developed as an evidence-based treatment for smoking cessation, however, the optimal rTMS dosing strategies have yet to be determined. Participant burden is an important component of determining optimal dosing strategy for rTMS as a treatment for long-term smoking cessation.
In this double-blinded, sham-controlled, randomized design, the effects of treatment duration, intensity, and active/sham assignment of rTMS on research burden were examined.
Overall level of perceived research burden was low. Experienced burden ( = 26.50) was significantly lower than anticipated burden ( = 34.12). Research burden did not vary by race or income.
Overall research burden was relatively low. Contrary to our hypotheses, we found little evidence of added significant burden for increasing the duration or intensity of rTMS, and we found little evidence for differences in research burden by race or income.
identifier NCT03865472.
将重复经颅磁刺激（rTMS）转化为基于证据的临床应用，依赖于对参与研究负担有不同看法的研究志愿者。此外，rTMS的临床应用需要在数周或数月内进行多次就诊，研究负担的影响是这些研究以及将这些发现转化为临床实践的重要组成部分。高频rTMS有很大潜力发展成为一种基于证据的戒烟治疗方法，然而，最佳的rTMS给药策略尚未确定。参与者负担是确定rTMS作为长期戒烟治疗的最佳给药策略的重要组成部分。
在这项双盲、假对照、随机设计中，研究了rTMS的治疗持续时间、强度以及主动/假刺激分配对研究负担的影响。
总体感知到的研究负担水平较低。经历的负担（=26.50）显著低于预期负担（=34.12）。研究负担在种族或收入方面没有差异。
总体研究负担相对较低。与我们的假设相反，我们几乎没有发现增加rTMS持续时间或强度会带来额外显著负担的证据，也几乎没有发现研究负担在种族或收入方面存在差异的证据。
标识符NCT03865472。
