Jingsong Wu1, Mengyu Han1, Youze He1, Xiaoting Xie1, Jian Song1, Xiujuan Geng2,3. 1. Fujian University of Traditional Chinese Medicine, Fuzhou, China. 2. Shenzhen Research Institute, The Chinese University of Hong Kong, Hong Kong, China. gengx@cuhk.edu.hk. 3. Brain and Mind Institute, The Chinese University of Hong Kong, 4F, Hui Yeung Shing Building, Shatin, N.T., Hong Kong, China. gengx@cuhk.edu.hk.
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.
RCT Entities:
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.
Entities:
Keywords:
Magnetic resonance imaging; Perceived stress; Repetitive transcranial magnetic stimulation; Theta burst stimulation; Young adult
Authors: P M Rossini; D Burke; R Chen; L G Cohen; Z Daskalakis; R Di Iorio; V Di Lazzaro; F Ferreri; P B Fitzgerald; M S George; M Hallett; J P Lefaucheur; B Langguth; H Matsumoto; C Miniussi; M A Nitsche; A Pascual-Leone; W Paulus; S Rossi; J C Rothwell; H R Siebner; Y Ugawa; V Walsh; U Ziemann Journal: Clin Neurophysiol Date: 2015-02-10 Impact factor: 3.708