Effects of Transcranial Pulse Stimulation (TPS) on Young Adults With Symptom of Depression: A Pilot Randomised Controlled Trial Protocol

Teris Cheung, Yuen Shan Ho, Jerry Wing-Fai Yeung, Sau Fong Leung, Kenneth N K Fong, Tommy Fong, Georg S Kranz, Roland Beisteiner, Calvin Pak Wing Cheng, Teris Cheung, Yuen Shan Ho, Jerry Wing-Fai Yeung, Sau Fong Leung, Kenneth N K Fong, Tommy Fong, Georg S Kranz, Roland Beisteiner, Calvin Pak Wing Cheng

Abstract

Background: Since the emergence of the COVID-19 pandemic, there have been lots of published work examining the association between COVID-19 and mental health, particularly, anxiety and depression in the general populations and disease subpopulations globally. Depression is a debilitating disorder affecting individuals' level of bio-psychological-social functioning across different age groups. Since almost all studies were cross-sectional studies, there seems to be a lack of robust, large-scale, and technological-based interventional studies to restore the general public's optimal psychosocial wellbeing amidst the COVID-19 pandemic. Transcranial pulse stimulation (TPS) is a relatively new non-intrusive brain stimulation (NIBS) technology, and only a paucity of studies was conducted related to the TPS treatment on older adults with mild neurocognitive disorders. However, there is by far no study conducted on young adults with major depressive disorder nationwide. This gives us the impetus to execute the first nationwide study evaluating the efficacy of TPS on the treatment of depression among young adults in Hong Kong.

Methods: This study proposes a two-armed single-blinded randomised controlled trial including TPS as an intervention group and a waitlist control group. Both groups will be measured at baseline (T1), immediately after the intervention (T2), and at the 3- month follow-up (T3).

Recruitment: A total of 30 community-dwelling subjects who are aged 18 and above and diagnosed with major depressive disorder (MDD) will be recruited in this study. All subjects will be computer randomised into either the intervention group or the waitlist control group, balanced by gender and age on a 1:1 ratio.

Intervention: All subjects in each group will have to undertake functional MRI (fMRI) before and after six 30-min TPS sessions, which will be completed in 2 weeks' time.

Outcomes: Baseline measurements and post-TPS evaluation of the psychological outcomes (i.e., depression, cognition, anhedonia, and instrumental activities of daily living) will also be conducted on all participants. A 3-month follow-up period will be usedto assess the long-term sustainability of the TPS intervention. For statistical analysis, ANOVA with repeated measures will be used to analyse data. Missing data were managed by multiple mutations. The level of significance will be set to p < 0.05.

Significance of the study: Results of this study will be used to inform health policy to determine whether TPS could be considered as a top treatment option for MDD.

Clinical trial registration: ClinicalTrials.gov, identifier: NCT05006365.

Keywords: RCT—randomised controlled trial; brain stimulation; efficacy; major depression (MDD); transcranial pulse stimulation.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Cheung, Ho, Yeung, Leung, Fong, Fong, Kranz, Beisteiner and Cheng.

Figures

Figure 1
Figure 1
Courtesy image from NEUROLITH-TPS manufacturer.
Figure 2
Figure 2
Post TPS stimulation images.
Figure 3
Figure 3
Patient is having a TPS session.
Figure 4
Figure 4
Transcranial Pulse Stimulation System, and TPS treatment venue, The Hong Kong Polytechnic University.
Figure 5
Figure 5
Flow diagram for participants' enrollment, randomisation, allocation, and follow-up (CONSORT, 2010).

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