Prefrontal Theta Burst Stimulation for Cognitive Improvement After ICU Delirium
This study aims to evaluate the effectiveness of Prefrontal Theta Burst Stimulation as a treatment to improve cognitive function in individuals who have experienced ICU delirium, measured by the time required to complete the Trails Making Test B.
Intermittent theta burst stimulation
+ Sham
Mental Disorders+9
+ Brain Diseases
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: February 13, 2026
Actual date on which the first participant was enrolled.This study focuses on older adults who have stayed in the intensive care unit (ICU) and experienced delirium, a sudden change in attention and awareness. Even after recovery, many survivors continue to face issues with memory, attention, and decision-making, which can affect daily activities. Currently, no specific treatments exist to improve these cognitive difficulties after ICU delirium. The study aims to test a noninvasive form of brain stimulation called intermittent theta burst stimulation (iTBS), which could potentially improve cognitive function in older ICU survivors who had delirium. The study targets the left dorsolateral prefrontal cortex, a brain region involved in attention and cognitive control, using a device cleared by the FDA for other conditions, like depression. The study involves up to 40 adults aged 50 to 75, approximately three months after an ICU stay with documented delirium. Participants will attend 11 visits over six weeks, including a baseline visit, 10 stimulation sessions over two weeks, and a one-month follow-up. Each stimulation session lasts about 15-20 minutes. Cognitive tests are conducted at baseline, immediately after the two-week stimulation period, and one month later. The primary outcome measure is the change in executive function, assessed using the Trail Making Test Part B. Additional tests evaluate attention, processing speed, language, and memory. The goals of this pilot study are to assess the feasibility, safety, and tolerability of the stimulation protocol and estimate the magnitude of cognitive changes. This research explores whether prefrontal neuromodulation could be a future strategy for cognitive recovery after ICU delirium.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 50 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Florida Shands Hospital
Gainesville, United StatesOpen University of Florida Shands Hospital in Google Maps