Treatment of Depression in the Elderly With Repetitive Transcranial Magnetic Stimulation Using Theta-Burst Stimulation: Study Protocol for a Randomized, Double-Blind, Controlled Trial

SOURCE: Frontiers in Human Neuroscience. 16 (no pagination), 2022. Article Number: 941981.


AUTHORS: Valiengo L.; Pinto B.S.; Marinho K.A.P.; Santos L.A.; Tort L.C.; Benatti R.G.; Teixeira B.B.; Miranda C.S.; Cardeal H.B.; Suen P.J.C.; Loureiro J.C.; Vaughan R.A.R.; Dini Mattar R.A.M.P.F.; Lessa M.; Oliveira P.S.; Silva V.A.; Gattaz W.F.; Brunoni A.R.; Forlenza O.V.

INTRODUCTION: Transcranial magnetic stimulation (TMS) is a consolidated procedure for the treatment of depression, with several meta-analyses demonstrating its efficacy. Theta-burst stimulation (TBS) is a modification of TMS with similar efficacy and shorter session duration. The geriatric population has many comorbidities and a high prevalence of depression, but few clinical trials are conducted specifically for this age group. TBS could be an option in this population, offering the advantages of few side effects and no pharmacological interactions. Therefore, our aim is to investigate the efficacy of TBS in geriatric depression.

METHODS: The study will be a randomized, double-blind, sham-controlled clinical trial in which volunteers will be recruited at the Clinical Hospital of the Medical School of the University of S?o Paulo. They will be allocated to one of two groups: active TBS or sham stimulation. Participants will receive 20 consecutive work days of TBS and will return at the end of 6, 8, and 12 weeks for a single session and evaluation of clinical outcomes. Those who do not present clinical improvement and were allocated to the sham group may choose to receive 20 days of active stimulation after the end of the trial. The study is ongoing (start date January, 2019); first enrollment occurred in April, 2020 and only 20% of the sample has been collected thus far. We will use advertisements on social media to recruit additional volunteers outside the hospital.

CONCLUSION: This study protocol was developed to investigate the efficacy of TBS for the treatment of MDD in elderly patients using a randomized, sham-controlled design. The biomarker investigation will contribute to understanding the neurobiological mechanisms of depression and their relationship with treatment. This trial will contribute valuable information to the treatment of depression in the elderly.