Post-delirium Cognitive ImpairmentNCT07452939
Prefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium
A study testing Intermittent theta burst stimulation in people with Post-delirium Cognitive Impairment, run by University of Florida at 1 site in United States.
Trial summary
Many older adults who survive a stay in the intensive care unit (ICU) experience delirium, a sudden change in attention and awareness caused by serious illness. Although delirium may resolve before hospital discharge, many survivors continue to experience ongoing problems with memory, attention, processing speed, and… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Post-delirium Cognitive Impairment
- What is being tested?
- Intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida Shands Hospital
Gainesville, Florida, 32610
Shixie Jiang, MD, 352-273-5391, delirium-lab@ufl.edu
About this study
Official title: Prefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium: A Randomized Sham-Controlled Pilot Trial
Many older adults who survive a stay in the intensive care unit (ICU) experience delirium, a sudden change in attention and awareness caused by serious illness. Although delirium may resolve before hospital discharge, many survivors continue to experience ongoing problems with memory, attention, processing speed, and executive function (such as planning, organizing, and multitasking). These cognitive difficulties can interfere with daily activities and may increase long-term risk for cognitive decline. Currently, there are no proven treatments specifically designed to improve thinking and attention after ICU delirium.
This study is testing whether a noninvasive form of brain stimulation called intermittent theta burst stimulation (iTBS) is safe, feasible, and potentially helpful for improving cognitive function in older ICU survivors who previously experienced delirium. iTBS is a patterned form of transcranial magnetic stimulation (TMS). It involves placing a magnetic coil gently against the scalp to deliver brief pulses of magnetic energy to a targeted region of the brain. In this study, stimulation is directed at the left dorsolateral prefrontal cortex, an area involved in attention, executive function, and cognitive control. The device used in this study is cleared by the U.S. Food and Drug Administration (FDA) for other conditions (such as depression), but its use for post-delirium cognitive impairment is investigational.
Read more
This is a randomized, double-blind, sham-controlled pilot trial. Up to 40 community-dwelling adults between the ages of 50 and 75 who are approximately three months after an ICU stay with documented delirium will participate. Individuals with known dementia or certain neurological or psychiatric conditions are excluded to ensure safety and interpretability of results.
Participation lasts approximately six weeks and includes 11 total visits: a baseline visit, 10 stimulation sessions over two weeks (five sessions per week), and a one-month follow-up visit. Each stimulation session lasts about 15-20 minutes. Cognitive testing is performed at baseline, immediately after the two-week stimulation period, and again one month later. The primary outcome measure is change in executive function, assessed using the Trail Making Test Part B. Additional tests measure attention, processing speed, language, and memory.
The primary goals of this pilot study are to evaluate feasibility (ability to recruit and retain participants), safety, and tolerability of the stimulation protocol, and to estimate the magnitude of any cognitive changes. This study is not designed to establish definitive clinical effectiveness but to generate data to inform larger future trials. The broader goal of this research is to explore whether prefrontal neuromodulation could become a future strategy to promote cognitive recovery after ICU delirium.
- Conditions
- Post-delirium Cognitive Impairment
- Being tested
- Intermittent theta burst stimulation, Sham
- Keywords
- delirium, dementia
- Medical subject headings
- Delirium, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta burst stimulationDevice
Intermittent theta burst stimulation (iTBS) will be delivered using an FDA-cleared Brain Ultimate M-Series transcranial magnetic stimulation system. Stimulation will target the left dorsolateral prefrontal cortex (DLPFC), localized using the Beam F3 scalp-based method. Each session consists of 600 magnetic pulses delivered over approximately 3 minutes using a standard intermittent theta burst pattern (bursts of 3 pulses at 50 Hz, repeated at 5 Hz), administered at 120% of the participant's resting motor threshold. Resting motor threshold will be determined by visual confirmation of motor-evoked movement in the right abductor pollicis brevis muscle.
ShamDevice
Sham stimulation will be delivered using the same Brain Ultimate M-Series transcranial magnetic stimulation system and figure-of-eight coil used in the active arm. The coil will be positioned at approximately a 45-degree angle relative to the scalp over the left dorsolateral prefrontal cortex (localized using the Beam F3 method) to minimize effective cortical stimulation while preserving auditory and tactile characteristics of active treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent theta burst stimulation | Active comparator | Not described Receives: Device: Intermittent theta burst stimulation |
| Sham | Sham comparator | Not described Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trails Making Test B
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.
Measured: From enrollment to one-month after the final TMS session
Secondary outcomes (9)
Trails Making Test A
Time (in seconds) required to complete Part A. Lower scores indicate better processing speed. Maximum allowable time: 300 seconds.
Measured: From enrollment to one-month after final TMS session
Psychomotor Vigilance Task
Measured: From enrollment to one-month after final TMS session
Digit Symbol Coding
Total number of correct symbols completed in 120 seconds.
Range: 0-135 (depending on version). Higher scores indicate better processing speed.
Measured: From enrollment to one-month after final TMS session
Controlled Oral Word Association Test
Total number of correct words generated in 60 seconds.
Range: 0 to unlimited. Higher scores indicate better verbal fluency.
Measured: From enrollment to one-month after final TMS session
Semantic Verbal Fluency Test
Total number of correct category exemplars generated in 60 seconds.
Range: 0 to unlimited. Higher scores indicate better performance.
Measured: From enrollment to one-month after final TMS session
Hopkins Verbal Learning Test
Hopkins Verbal Learning Test - Revised (HVLT-R).
Total recall score across three learning trials.
Range: 0-36. Higher scores indicate better verbal learning.
Delayed recall:
Range: 0-12. Higher scores indicate better memory retention.
Measured: From enrollment to one-month after final TMS session
Logical Memory 1 and 2
Logical Memory 1:
0 to 50 (maximum raw score depends on scoring criteria; confirm exact maximum with manual - typically 50 units).
Higher scores indicate better immediate verbal memory.
Logical Memory 2:
Score range:
0 to 50 (same unit structure as LM I).
Higher scores indicate better delayed verbal memory.
Measured: From enrollment to one-month after final TMS session
Craft Story 21 Recall
Score range:
0 to 44
Directionality:
Higher scores indicate better verbal episodic memory.
Measured: From enrollment to one-month after final TMS session
Montreal Cognitive Assessment Test
Total score range: 0-30. Higher scores indicate better global cognitive function
Measured: From enrollment to one-month after final TMS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start13 Feb 2026
- Primary completion21 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-delirium Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452939
- Sponsor's protocol ID
- IRB202501241
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fuseya K, Mimura Y, Nakajima S, Mimura M, Kasanuki K, Noda Y. A systematic review and meta-analysis on the characteristics of transcranial magnetic stimulation treatment protocols for patients with Alzheimer's disease. J Alzheimers Dis. 2025 May;105(1):28-43. doi: 10.1177/13872877251325887. Epub 2025 Mar 20.
PubMed 40112319Chou YH, Ton That V, Sundman M. A systematic review and meta-analysis of rTMS effects on cognitive enhancement in mild cognitive impairment and Alzheimer's disease. Neurobiol Aging. 2020 Feb;86:1-10. doi: 10.1016/j.neurobiolaging.2019.08.020. Epub 2019 Aug 27.
PubMed 31783330Pabst A, Proksch S, Mede B, Comstock DC, Ross JM, Balasubramaniam R. A systematic review and meta-analysis of the efficacy of intermittent theta burst stimulation (iTBS) on cognitive enhancement. Neurosci Biobehav Rev. 2022 Apr;135:104587. doi: 10.1016/j.neubiorev.2022.104587. Epub 2022 Feb 22.
PubMed 35202646Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
PubMed 24088092Girard TD, Jackson JC, Pandharipande PP, Pun BT, Thompson JL, Shintani AK, Gordon SM, Canonico AE, Dittus RS, Bernard GR, Ely EW. Delirium as a predictor of long-term cognitive impairment in survivors of critical illness. Crit Care Med. 2010 Jul;38(7):1513-20. doi: 10.1097/CCM.0b013e3181e47be1.
PubMed 20473145
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium: A Randomized Sham-Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07452939
- Acronym / sponsor ID
- IRB202501241
- Conditions
- Post-delirium Cognitive Impairment
- Keywords
- delirium, dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 21 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many older adults who survive a stay in the intensive care unit (ICU) experience delirium, a sudden change in attention and awareness caused by serious illness. Although delirium may resolve before hospital discharge, many survivors continue to experience ongoing problems with memory, attention, processing speed, and executive function (such as planning, organizing, and multitasking). These cognitive difficulties can interfere with daily activities and may increase long-term risk for cognitive decline. Currently, there are no proven treatments specifically designed to improve thinking and attention after ICU delirium.
This study is testing whether a noninvasive form of brain stimulation called intermittent theta burst stimulation (iTBS) is safe, feasible, and potentially helpful for improving cognitive function in older ICU survivors who previously experienced delirium. iTBS is a patterned form of transcranial magnetic stimulation (TMS). It involves placing a magnetic coil gently against the scalp to deliver brief pulses of magnetic energy to a targeted region of the brain. In this study, stimulation is directed at the left dorsolateral prefrontal cortex, an area involved in attention, executive function, and cognitive control. The device used in this study is cleared by the U.S. Food and Drug Administration (FDA) for other conditions (such as depression), but its use for post-delirium cognitive impairment is investigational.
This is a randomized, double-blind, sham-controlled pilot trial. Up to 40 community-dwelling adults between the ages of 50 and 75 who are approximately three months after an ICU stay with documented delirium will participate. Individuals with known dementia or certain neurological or psychiatric conditions are excluded to ensure safety and interpretability of results.
Participation lasts approximately six weeks and includes 11 total visits: a baseline visit, 10 stimulation sessions over two weeks (five sessions per week), and a one-month follow-up visit. Each stimulation session lasts about 15-20 minutes. Cognitive testing is performed at baseline, immediately after the two-week stimulation period, and again one month later. The primary outcome measure is change in executive function, assessed using the Trail Making Test Part B. Additional tests measure attention, processing speed, language, and memory.
The primary goals of this pilot study are to evaluate feasibility (ability to recruit and retain participants), safety, and tolerability of the stimulation protocol, and to estimate the magnitude of any cognitive changes. This study is not designed to establish definitive clinical effectiveness but to generate data to inform larger future trials. The broader goal of this research is to explore whether prefrontal neuromodulation could become a future strategy to promote cognitive recovery after ICU delirium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent theta burst stimulation | Active comparator | Device: Intermittent theta burst stimulation |
| Sham | Sham comparator | Device: Sham |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent theta burst stimulationIntermittent theta burst stimulation (iTBS) will be delivered using an FDA-cleared Brain Ultimate M-Series transcranial magnetic stimulation system. Stimulation will target the left dorsolateral prefrontal cortex (DLPFC), localized using the Beam F3 scalp-based method. Each session consists of 600 magnetic pulses delivered over approximately 3 minutes using a standard intermittent theta burst pattern (bursts of 3 pulses at 50 Hz, repeated at 5 Hz), administered at 120% of the participant's resting motor threshold. Resting motor threshold will be determined by visual confirmation of motor-evoked movement in the right abductor pollicis brevis muscle. | Device | Intermittent theta burst stimulation |
| ShamSham stimulation will be delivered using the same Brain Ultimate M-Series transcranial magnetic stimulation system and figure-of-eight coil used in the active arm. The coil will be positioned at approximately a 45-degree angle relative to the scalp over the left dorsolateral prefrontal cortex (localized using the Beam F3 method) to minimize effective cortical stimulation while preserving auditory and tactile characteristics of active treatment. | Device | Sham |
Primary outcome
Trails Making Test B
Time frame: From 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.
9 secondary outcomes
Trails Making Test A
Time frame: From enrollment to one-month after final TMS session
Psychomotor Vigilance Task
Time frame: From enrollment to one-month after final TMS session
Digit Symbol Coding
Time frame: From enrollment to one-month after final TMS session
Controlled Oral Word Association Test
Time frame: From enrollment to one-month after final TMS session
Semantic Verbal Fluency Test
Time frame: From enrollment to one-month after final TMS session
Hopkins Verbal Learning Test
Time frame: From enrollment to one-month after final TMS session
Logical Memory 1 and 2
Time frame: From enrollment to one-month after final TMS session
Craft Story 21 Recall
Time frame: From enrollment to one-month after final TMS session
Montreal Cognitive Assessment Test
Time frame: From enrollment to one-month after final TMS session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Background: PubMed 40112319Fuseya K, Mimura Y, Nakajima S, Mimura M, Kasanuki K, Noda Y. A systematic review and meta-analysis on the characteristics of transcranial magnetic stimulation treatment protocols for patients with Alzheimer's disease. J Alzheimers Dis. 2025 May;105(1):28-43. doi: 10.1177/13872877251325887. Epub 2025 Mar 20.
- Background: PubMed 31783330Chou YH, Ton That V, Sundman M. A systematic review and meta-analysis of rTMS effects on cognitive enhancement in mild cognitive impairment and Alzheimer's disease. Neurobiol Aging. 2020 Feb;86:1-10. doi: 10.1016/j.neurobiolaging.2019.08.020. Epub 2019 Aug 27.
- Background: PubMed 35202646Pabst A, Proksch S, Mede B, Comstock DC, Ross JM, Balasubramaniam R. A systematic review and meta-analysis of the efficacy of intermittent theta burst stimulation (iTBS) on cognitive enhancement. Neurosci Biobehav Rev. 2022 Apr;135:104587. doi: 10.1016/j.neubiorev.2022.104587. Epub 2022 Feb 22.
- Background: PubMed 24088092Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
- Background: PubMed 20473145Girard TD, Jackson JC, Pandharipande PP, Pun BT, Thompson JL, Shintani AK, Gordon SM, Canonico AE, Dittus RS, Bernard GR, Ely EW. Delirium as a predictor of long-term cognitive impairment in survivors of critical illness. Crit Care Med. 2010 Jul;38(7):1513-20. doi: 10.1097/CCM.0b013e3181e47be1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta burst stimulation in people with Post-delirium Cognitive Impairment, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shixie Jiang, MD (352-273-5391, delirium-lab@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trails Making Test B (time frame: From enrollment to one-month after the final TMS session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07452939, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.