Could magnetic pulses restore memory after ICU delirium?
NCT ID NCT07452939
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
Many older adults who survive an ICU stay with delirium continue to have trouble with memory, attention, and planning. This pilot study tests whether a noninvasive brain stimulation technique called intermittent theta burst stimulation (iTBS) can safely improve these cognitive problems. Forty adults aged 50 to 75 who had ICU delirium will receive either real or sham stimulation over two weeks, and their thinking skills will be tested before, right after, and one month later. The goal is to see if this approach is feasible and worth testing in larger trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intermittent theta burst stimulation (iTBS) using a transcranial magnetic stimulation device
- What this could lead to
- If it works, this could point toward a safe, non-drug treatment to help older adults recover thinking skills after ICU delirium.
- What could go wrong
- This is a very early pilot study with only 40 people. It is designed to test feasibility, not effectiveness, so results may not show clear benefit. The stimulation is investigational for this use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 supranuclear palsy, multiple sclerosis, hematomas, traumatic or anoxic brain injury) * Structural CT/MRI with evidence of infection or other clinically significant focal lesions (cortical strokes not large enough to distort anatomy and/or multiple lacunar infarctions ≤ 1.5cm and/or extensive white matter disease are allowed) * Unstable or decompensated cardiac disease (e.g., \<3 months myocardial infarction, unstable angina, decompensated congestive heart failure NYHA class 3-4) * Pacemaker * Cochlear implants * Implanted medication pumps * Intracranial metal implants * Previous TMS treatment * Pregnancy (negative urine or serum b-HCG or history of prior surgical sterilization or post-menopausal status \[12 months or more of amenorrhea\]) * Current depressive disorder (Beck Depression Inventory score15 \<13) * History of suicide attempts * Schizophrenia * Bipolar disorder * Alcohol or substance abuse * Severe visual/hearing impairment. * Informant Questionnaire on Cognitive Decline in the Elderly16 (IQCODE) score ≥3.4 (suggesting prior cognitive decline)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Florida Shands Hospital
RECRUITINGGainesville, Florida, 32610, United States