ABSTRACT
Introduction: Depression is a debilitating disorder affecting individuals' level of bio-psychosocial functioning across different age groups around the globe. The recent development of a new NIBS called Transcranial Pulse Stimulation (TPS), also known as low-intensity extracorporeal shock wave therapy (Li-ESWT), has been proven effective for only a 2-week treatment of 35 patients with Alzheimer's disease (AD). Patients' cognition and memory have shown significant improvement which lasted up to 3 months. However, there is a lack of scientific evidence on the efficacy of this TPS intervention on other psychiatric population such as Major Depressive Disorder (MDD), which is increasingly prevalent in Hong Kong and nationwide especially during the COVID-19 pandemic. Nonetheless, there is no trial evaluating the efficacy of TPS on other neuropsychiatric disorders. This gave us the impetus to evaluate the efficacy of TPS on young adults with Major Depressive Disorder (MDD) in Hong Kong. Method(s): In this single-blinded, randomized controlled trial, participants had a confirmed clinical diagnosis of MDD, recruited from the community, NGOs and private enterprise. The intervention was a 2-week TPS treatment comprised six 30-min TPS sessions, delivered by trained mental health professionals. A total of 30 participants were recruited and randomized into either the TPS group or the Waitlist Control (WC) group. Randomization was stratified by gender and age by an independent statistician on a 1:1 ratio. Our primary outcome was determined by whether participants' depressive symptom severity demonstrated significant reduction, compared with the WC group, using the Hamilton Depression Rating Scale-17 (HDRS17). This trial is registered with Clin.Trials.gov, number NCT05006365. Result(s): We recruited 30 participants from 1 August to 31 Oct 2021. They were between 18-54 years old and were predominantly female (73%), ethnically Chinese. There was a significant group x time interaction (F(1, 28) = 818.8, p <.001). Compared with the WC group, there was a significant reduction in the depressive symptom severity in the TPS group (mean difference = -6.60, p = 0.02, Cohen's d = -0.93). Results showed a significant intervention effect and the effect was large. Conclusion(s): TPS is safe and effective to reduce depressive symptoms among young individuals with MDD in this trial. Therefore, TPS may be considered as a top treatment option for neuropsychiatric disorders in clinical psychiatry. Funding(s): This trial is funded by the Departmental General Research Fund, the Hong Kong Polytechnic University, Hong Kong SAR, China. Copyright © 2022
ABSTRACT
Background: The goal of this study was to assess whether TMS treatment outcomes for patients with major depressive disorder (MDD) were as robust post-COVID-19 as they were pre-COVID-19 and whether patient demographics, particularly the age of patients presenting for TMS, changed during the pandemic. Method(s): As part of the DONT H8 retrospective observational outcomes study (1), we further stratified the data to examine treatment outcomes for patients who were treated pre- and post-COVID-19 (prior to and after January 1, 2020). The primary outcome measure was change in Patient Health Questionnaire-9 (PHQ-9) score at the end of treatment. A secondary outcome was to assess whether age demographics of patients seeking TMS shifted during the pandemic and whether there was correlation between patient age and clinical outcome. Result(s): T-tests for two correlated samples showed that the responder rate was 48.5% for patients treated pre-COVID-19 compared to 58.2% post-COVID-19. Chi-Square analysis found the 9.70% difference in PHQ-9 responder rates between groups to be statistically significant in favor of patients treated post-COVID-19 (Chi-Square=4.43, p=0.035, p<0.05). The mean age of patients treated pre-COVID-19 was 52.42 years compared to 47.03 years post-COVID-19 and the 5.39 mean age difference was statistically significant (p<0.0005). However, patients older than age 60 (n = 186) had statistically significant improvement in PHQ-9 scores (54%) compared to the younger patients (mean range of improvement 40-49%) (p = 0.01928). Conclusion(s): The DONT H8 study is the largest naturalistic study to date showing a statistically significant improvement in responder rates (9.70%) in favor of patients treated after the start of the COVID-19 pandemic. The age of patients receiving TMS during the pandemic is significantly younger although patients older than age 60 have experienced the most clinical improvement. Conflicts of Interest: None Funding: No outside funding was obtained. Consultant statistical analysis was used to verify findings. Disclosures: Dr. Raj has served as a consultant to Eisai Inc. Reference: 1. Raj YP, Lindberg N. The Dual Observation Naturalistic TMS Study Comparing H1 and Figure-8 Coil Outcomes (DONT H8). Clinical TMS Society 10th Annual Meeting, May, 2022. Copyright © 2022