Clinical trial for Post-delirium Cognitive Impairment
Official title Prefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium
ClinicalTrials.gov ID: NCT07452939
What this study is testing
- What it's testing
- The study wants to find out if the stimulation is safe, easy to use, and might help with memory, attention, and planning after ICU delirium.
- Who it's for
- Adults aged 50‑75 who lived at home, had an ICU stay about three months ago, and had delirium during that stay.
- What's involved
- Participants will have 10 15‑ to 20‑minute stimulation sessions over two weeks, plus baseline and follow‑up visits with cognitive tests. A sham (placebo) group will receive a fake treatment to keep the study blind.
- Time commitment
- The study lasts about six weeks, with 11 visits total: one baseline, 10 stimulation sessions, and a one‑month follow‑up.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 75
You may be able to join if
- Eligible individuals must have experienced an ICU admission with documented delirium (confirmed via documented Confusion Assessment Method for the...
- 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
You likely can't join 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...
- Structural CT/MRI with evidence of infection or other clinically significant focal lesions (cortical strokes not large enough to distort anatomy...
- Unstable or decompensated cardiac disease (e.g., \<3 months myocardial infarction, unstable angina, decompensated congestive heart failure NYHA class...
- Pacemaker
See the full eligibility 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...
- 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.
- 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...
- 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 study team makes the final eligibility decision.
Where it is enrolling
- Gainesville, Florida, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gainesville, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.