Prefrontal intermittent theta burst stimulation for thinking problems after ICU delirium

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial enrolls community-dwelling adults aged 50–75 who are about three months after an ICU stay complicated by documented delirium and who have mild cognitive impairment on the MoCA (18–25). Participants receive either active intermittent theta burst stimulation (iTBS), a patterned form of transcranial magnetic stimulation, or a sham procedure applied over the prefrontal cortex across multiple sessions. The study tracks safety, feasibility, and changes in cognitive domains including attention, processing speed, memory, and executive function before and after the intervention. Results will guide whether larger trials of iTBS for post-delirium cognitive impairment are warranted.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Florida Shands Hospital
  Gainesville, Florida, United States Recruiting

Study contacts

• Study coordinator: Shixie Jiang, MD
• Email: delirium-lab@ufl.edu
• Phone: 352-273-5391

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.