Testing Accelerated Deep Transcranial Magnetic Stimulation to Treat Depression in Older Adults ages 60 to 85

What this Trial Is About

Researchers are evaluating an accelerated deep Transcranial Magnetic Stimulation dTMS protocol to reduce depressive symptoms in older adults aged 60 to 85 with Major Depressive Disorder MDD who have not responded well to or tolerated antidepressant medications. This study aims to assess the safety, tolerability, and preliminary efficacy of delivering multiple dTMS sessions per day over five consecutive days compared to a placebo stimulation. The trial is a single-site, double-blind, randomized sham-controlled design focusing on treatment-resistant depression in older adults. Participants will be randomly assigned to receive either active dTMS using the H7 coil or a sham intervention designed to mimic treatment sensations without brain stimulation. The active treatment involves 6 to 8 intermittent theta burst stimulation sessions daily at 80-90% of resting motor threshold over five days. The sham group will receive similar technical procedures without actual brain stimulation. This accelerated protocol seeks to determine feasibility and gather early evidence about the treatments impact on depressive symptoms. During the study, participants will be monitored for attendance, comfort, adverse events, and withdrawal reasons over six weeks. Outcome measures include changes in depression rating scores one week after treatment, response and remission rates, brain activity changes measured by EEG, MRI, and MEG, as well as cognitive and emotional processing assessments up to one month following treatment. The trial will also evaluate heart rate variability and emotional task performance, ensuring comprehensive safety and efficacy monitoring throughout the participation period.

Accelerated Neuromodulation of Anterior Cingulate Cortex for Depression