scholarly journals The Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) for Young Individuals with High-Level Perceived Stress: Study Protocol for a Randomized Sham-Controlled Trial

2021 ◽  
Author(s):  
Jingsong Wu ◽  
Mengyu Han ◽  
Youze He ◽  
Xiaoting Xie ◽  
Jian Song ◽  
...  

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 four 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: This study is registered with the Chinese Clinical Trial Registry (ChiCTR1900027662) (http://www.chictr.org.cn/showproj.aspx?proj=45660). Registered 23th November 2019.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jingsong Wu ◽  
Mengyu Han ◽  
Youze He ◽  
Xiaoting Xie ◽  
Jian Song ◽  
...  

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.


BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050098
Author(s):  
Fang Han ◽  
Shuai Tao ◽  
Shanshan Liang ◽  
Danyang Li ◽  
Yutong Me ◽  
...  

IntroductionDepression is characterised by easy recurrence, high disability and high burden, and antidepressant therapy is the standard treatment. However, its treatment effect on patients with severe depressive disorder has been unsatisfactory. Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS), as a neurotherapy, can effectively mitigate the severity of depressive symptoms. Yet, more evidence is still required for TMS to treat severe depression. This study will be the first systematic review of the efficacy and tolerability of TMS for treating severe depression. We expect it to guide future clinical practice of TMS for the treatment of psychiatric disorders.Methods and analysisWe will search for the randomised controlled trial (RCT) involving rTMS for treating depression in eight electronic databases, including PubMed, Web of Science, EMBASE, the Cochrane Library and Wanfang Database, from publication up to September 2021. We will define Improvement in depressive symptoms, the difference between pretreatment (baseline) and post-treatment as the primary outcomes. The difference between pretreatment and post-treatment changes in resting state fMRI will be regarded as the secondary outcomes. Quality assessment of the included articles will be independently performed according to the Cochrane Risk of Bias tool.Ethics and disseminationEthical approval is not essential because there is no need to collect individual patient data. And this study will be published in a peer-reviewed journal.Trial registration numberCRD42020211460.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Francesco Di Gregorio ◽  
Fabio La Porta ◽  
Emanuela Casanova ◽  
Elisabetta Magni ◽  
Roberta Bonora ◽  
...  

Abstract Background Left hemispatial neglect (LHN) is a neuropsychological syndrome often associated with right hemispheric stroke. Patients with LHN have difficulties in attending, responding, and consciously representing the right side of space. Various rehabilitation protocols have been proposed to reduce clinical symptoms related to LHN, using cognitive treatments, or on non-invasive brain stimulation. However, evidence of their benefit is still lacking; in particular, only a few studies focused on the efficacy of combining different approaches in the same patient. Methods In the present study, we present the SMART ATLAS trial (Stimolazione MAgnetica Ripetitiva Transcranica nell’ATtenzione LAteralizzata dopo Stroke), a multicenter, randomized, controlled trial with pre-test (baseline), post-test, and 12 weeks follow-up assessments based on a novel rehabilitation protocol based on the combination of brain stimulation and standard cognitive treatment. In particular, we will compare the efficacy of inhibitory repetitive-transcranial magnetic stimulation (r-TMS), applied over the left intact parietal cortex of LHN patients, followed by visual scanning treatment, in comparison with a placebo stimulation (SHAM control) followed by the same visual scanning treatment, on visuospatial symptoms and neurophysiological parameters of LHN in a population of stroke patients. Discussion Our trial results may provide scientific evidence of a new, relatively low-cost rehabilitation protocol for the treatment of LHN. Trial registration ClinicalTrials.gov NCT04080999. Registered on September 2019.


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