Prefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium
Many older adults who survive a stay in the intensive care unit (ICU) experience delirium, a sudden change in attention and awareness caused by serious illness. Although delirium may resolve before hospital discharge, many survivors continue to experience ongoing problems with memory, attention, processing speed, and e
| Condition(s) | Post-delirium Cognitive Impairment |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Many older adults who survive a stay in the intensive care unit (ICU) experience delirium, a sudden change in attention and awareness caused by serious illness. Although delirium may resolve before hospital discharge, many survivors continue to experience ongoing problems with memory, attention, processing speed, and executive function (such as planning, organizing, and multitasking). These cognitive difficulties can interfere with daily activities and may increase long-term risk for cognitive decline. Currently, there are no proven treatments specifically designed to improve thinking and attention 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 improv |
| Who can participate | Inclusion Criteria: * Eligible individuals must have experienced an ICU admission with documented delirium (confirmed via documented Confusion Assessment Method for the ICU score12 \[CAM-ICU\] or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition13(p5) \[DSM-5\] criteria) * Age 50 to 75 years old * 3 months post-ICU discharge at time of enrollment (defined as within 90 ± 14 days) * English fluency * Family or close friend for collateral * Community-dwelling status * Montreal Cognitive Assessment14 score between 18 and 25. Exclusion Criteria: * Diagnosis of mild cognitive impairment or dementia (prior to delirium episode) * Seizure disorder * Other significant neurologic disease (e.g., Parkinson's, Huntington's, Normal pressure hydrocephalus, tumor, progressive supranuclea |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Lead sponsor | University of Florida |
| Locations | Gainesville, Florida, United States |
| Start date | 2026-02-13 |
| NCT ID | NCT07452939 |
| Official listing | https://clinicaltrials.gov/study/NCT07452939 |