Back to search results

Theta Burst Stimulation for Post-ICU Delirium Cognitive Impairment

This study is looking at whether a treatment called intermittent theta burst stimulation (iTBS) can help improve thinking and memory problems in older adults who have experienced delirium after an intensive care unit (ICU) stay. Delirium is a sudden change in attention and awareness. Many people who have delirium in the ICU continue to have issues with memory, attention, and planning even after they leave the hospital. iTBS uses a special device to deliver magnetic pulses to a specific area of the brain (the left dorsolateral prefrontal cortex). Researchers will compare iTBS to a sham (inactive) treatment. The main goal is to see if iTBS improves cognitive function, measured by a test called Trails Making Test B, up to one month after the last treatment. You might be able to join if you are between 50 and 75 years old, had documented delirium during an ICU stay, and are at least three months past your ICU discharge. The study plans to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study comparing active treatment to a sham treatment, planning to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your cognitive function will be measured from enrollment up to one month after your final treatment session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07452939

Prefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium

Recruiting
NAAges 50–75InterventionalTreatment
University of Florida
~40 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:Intermittent theta burst stimulationSham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Trails Making Test B
Measured over From enrollment to one-month after the final TMS session

Conditions

Post-delirium Cognitive Impairment

Explore related trials

Cognitive DysfunctionDelirium

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Shixie Jiang, MD
[email protected]
352-273-5391
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Trails Making Test BFrom enrollment to one-month after the final TMS session

    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.