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NCT07452939 · ClinicalTrials.gov registry record · NA
Prefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium
A NA study of Post-delirium Cognitive Impairment, sponsored by University of Florida.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07452939: Recruiting NA study of Post-delirium Cognitive Impairment, sponsored by University of Florida.
NCT07452939 is a NA study of Post-delirium Cognitive Impairment that is actively recruiting participants, run by University of Florida. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07452939, a NA study of Post-delirium Cognitive Impairment, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 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 fol
Primary Outcome
Time (in seconds) required to complete Part B. Lower scores indicate better executive functioning. There is no fixed maximum score; the test is typically discontinued at 300 seconds. Range 0-300 seconds.
Conditions Studied
Interventions
- DEVICE Sham
- DEVICE Intermittent theta burst stimulation
Study Locations (1)
Florida
- University of Florida Shands Hospital - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-02-13 |
| Est. Completion | 2027-04-01 |
| Phase | NA |
What NCT07452939 shows while recruiting
NCT07452939 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Post-delirium Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Sham is the first listed.
NCT07452939 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT07452939 about?
NCT07452939 is a clinical study titled "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, pro...
What is the current status of trial NCT07452939?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2026-02-13. Estimated completion is 2027-04-01.
What conditions does trial NCT07452939 study?
This clinical trial studies the following conditions: Post-delirium Cognitive Impairment.
What interventions are being tested in trial NCT07452939?
The interventions under investigation include: Sham (DEVICE), Intermittent theta burst stimulation (DEVICE).
Who is sponsoring clinical trial NCT07452939?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07452939 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07452939's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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