NCT07452939 · RECRUITING
Prefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium
This pilot trial is testing whether a noninvasive brain stimulation technique called intermittent theta burst stimulation (iTBS) — essentially targeted magnetic pulses delivered through the scalp — can safely improve thinking and attention in adults who had delirium during an ICU stay. Participants receive 10 stimulation sessions over two weeks, about three months after discharge. This is a Phase NA pilot study, meaning the goal is to check safety and feasibility, not to prove the treatment works.
You may qualify if
- 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.
You're excluded if
- 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)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-11