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

Abstract

BackgroundSince 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.MethodsThis 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).RecruitmentA 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.InterventionAll 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.OutcomesBaseline 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 StudyResults 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 RegistrationClinicalTrials.gov, identifier: NCT05006365.

Evaluating the efficacy and safety of transcranial pulse stimulation on adolescents with attention deficit hyperactivity disorder: Study protocol of a pilot randomized, double-blind, sham-controlled trial

“…To the best of our knowledge, there is no interventional study evaluating the efficacy of TPS on ADHD. Based on our previous open-label pilot RCT ( 39 ) evaluating TPS in adults with major depressive disorder that showed a large effect size (d = 0.91), we hypothesize a large effect of TPS in this study. We used G * power version 3.1.9.4 to calculate the target sample size.…”

“…A total of 30 subjects (18–51 years) were administered six TPS sessions over 2 weeks (total TPS pulse: 1,800–2,400, 2.5–3.0 Hz). Results showed significant improvement in the depression severity in the verum TPS group compared to WC ( p = 0.02), and the effect size was very large (Cohen's d = −0.9) ( 39 ). However, both Beisteiner et al ( 29 ) and Cheung et al's ( 39 ) studies were uncontrolled studies or open-label RCTs without a sham control group.…”

“…Results showed significant improvement in the depression severity in the verum TPS group compared to WC ( p = 0.02), and the effect size was very large (Cohen's d = −0.9) ( 39 ). However, both Beisteiner et al ( 29 ) and Cheung et al's ( 39 ) studies were uncontrolled studies or open-label RCTs without a sham control group. Placebo effects have to be considered when interpreting results.…”

Bilateral repetitive transcranial magnetic stimulation ameliorated sleep disorder and hypothalamic–pituitary–adrenal axis dysfunction in subjects with major depression

“…Traditionally, pharmacological treatment and psychotherapy have been used as conventional treatment in psychiatry ( 8 ). However, one novel approach to MDD management over the last decades is repetitive transcranial magnetic stimulation (rTMS) ( 9 ).…”

Evaluating the Safety and Efficacy of Transcranial Pulse Stimulation on Autism Spectrum Disorder: A Double-Blinded, Randomized, Sham-Controlled Trial Protocol

“…Study findings reported significant improvements in memory and cognition, a reduction in depressive symptoms [ 6 ], and a reduction in cortical atrophy [ 7 ]. Another local pilot open-label RCT also proved that TPS is effective in significantly reducing depression severity in adults diagnosed with major depressive disorder [ 8 ] in Hong Kong. Nonetheless, there is so far no further study using TPS evaluating the efficacy and safety on young adolescents with ASD.…”