The efficacy of repetitive transcranial magnetic stimulation (rTMS) for young individuals with high-level perceived stress: study protocol for a randomized sham-controlled trial

Abstract

Background High level of perceived stress may result in negative effects both psychologically and physically on individuals and may predispose onset of mental disorders such as depression, anxiety, and posttraumatic stress disorder. However, there is no suitable intervention for it. Repetitive transcranial magnetic stimulation (rTMS) studies have shown its therapeutic efficacy in treatment resistant patients with stress-related disorders. Here we describe an exploratory study protocol to investigate the effect of the intervention for the individuals with high level of stress. Method This is a single blinded, randomized sham-controlled trial, targeting at young healthy adults aging from 18 to 24 years old. Forty eligible volunteers will be recruited and randomly divided into active and sham rTMS group. All subjects will take a set of neuropsychological and biological assessments and MRI scanning before and right after the intervention. During the interventional period, 12-session stimulations will be performed in 4 weeks with three sessions per week. The primary outcome will detect the difference of Chinese 14-item perceived stress scales between active and sham rTMS groups after intervention. Secondary outcomes will examine the differences of other affective measurements, level of cortisol, and MRI-derived neural functional measures between the two groups after intervention. Discussion This trial aims to examine the effect of the 12-session rTMS intervention on individuals with high level of perceived stress. Positive or negative findings from any of the outcome measures would further our understanding of the efficacy of the stimulation and its neural impact. If effective, it would provide an evidence for a new treatment for high perceived stress. Trial registration Chinese Clinical Trial Registry (ChiCTR1900027662). Registered on 23 November 2019. And all items of the WHO Trial Registry Data set can be found within the protocol.

Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial

“…In this study, code I is defined as the rTMS group, and code II is defined as the sham rTMS group. Each parameter of randomization will be kept in a special sealed opaque envelope as previously reported [ 25 ].…”

“…First, the comparison of the baseline data between the two groups will be performed using Student’s t test, chi-squared test, or nonparametric test according to the type and distribution of variables. To verify the therapeutic efficacy of our intervention, comparisons of all the outcomes that are categorized as continuous variables and shown in mean scores will be included in the analysis by independent sample t- test or non-parametric test (Wilcoxon and Mann–Whitney U tests) depending on the distribution of the data [ 16 , 25 ]. If the data are distributed normally and the variances are equal, independent samples t- tests will be used for comparisons of the before and after treatment changes between groups, including the mean differences between groups, with 95% CIs.…”