Prefrontal intermittent theta burst stimulation for thinking problems after ICU delirium
Prefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium: A Randomized Sham-Controlled Pilot Trial
NA · University of Florida · NCT07452939
This trial will test whether intermittent theta burst brain stimulation can safely improve thinking, memory, and attention in older adults who had delirium during an ICU stay.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT07452939 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English-speaking, community-dwelling adults age 50–75 who are about three months post-ICU discharge, had documented ICU delirium, can provide a family collateral, and have a MoCA score between 18 and 25.
Not a fit: People with pre-existing dementia or mild cognitive impairment before their ICU stay, a seizure disorder, major neurological disease, large focal brain lesions, or who cannot travel to the site are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, iTBS could provide a noninvasive option to improve daily thinking, attention, and memory in ICU survivors with lingering cognitive problems.
How similar studies have performed: TMS and iTBS have shown benefit for depression and some cognitive symptoms in other populations, but their use specifically for post-ICU delirium cognitive impairment is novel with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gainesville, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-delirium Cognitive Impairment, delirium, dementia