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Prefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium
NCT07452939 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07452939
The ClinicalTrials.gov registry entry for NCT07452939 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,066 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07452939 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07452939?
The interventions under investigation include: Sham (DEVICE), Intermittent theta burst stimulation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07452939?
This trial is sponsored by University of Florida, which has 1,066 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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