Prefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium

This study is testing whether a noninvasive form of brain stimulation called intermittent theta burst stimulation (iTBS) is safe, feasible, and potentially helpful for improving cognitive function in older ICU survivors who previously experienced delirium. iTBS is a patterned form of transcranial magnetic stimulation (TMS). It involves placing a magnetic coil gently against the scalp to deliver brief pulses of magnetic energy to a targeted region of the brain. In this study, stimulation is directed at the left dorsolateral prefrontal cortex, an area involved in attention, executive function, and cognitive control. The device used in this study is cleared by the U.S. Food and Drug Administration (FDA) for other conditions (such as depression), but its use for post-delirium cognitive impairment is investigational.

This is a randomized, double-blind, sham-controlled pilot trial. Up to 40 community-dwelling adults between the ages of 50 and 75 who are approximately three months after an ICU stay with documented delirium will participate. Individuals with known dementia or certain neurological or psychiatric conditions are excluded to ensure safety and interpretability of results.

Participation lasts approximately six weeks and includes 11 total visits: a baseline visit, 10 stimulation sessions over two weeks (five sessions per week), and a one-month follow-up visit. Each stimulation session lasts about 15-20 minutes. Cognitive testing is performed at baseline, immediately after the two-week stimulation period, and again one month later. The primary outcome measure is change in executive function, assessed using the Trail Making Test Part B. Additional tests measure attention, processing speed, language, and memory.

The primary goals of this pilot study are to evaluate feasibility (ability to recruit and retain participants), safety, and tolerability of the stimulation protocol, and to estimate the magnitude of any cognitive changes. This study is not designed to establish definitive clinical effectiveness but to generate data to inform larger future trials. The broader goal of this research is to explore whether prefrontal neuromodulation could become a future strategy to promote cognitive recovery after ICU delirium.