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Prefrontal Theta Burst Stimulation for Cognitive Improvement After ICU Delirium

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Study Aim

This study aims to evaluate the effectiveness of Prefrontal Theta Burst Stimulation as a treatment to improve cognitive function in individuals who have experienced ICU delirium, measured by the time required to complete the Trails Making Test B.

What is being tested

Intermittent theta burst stimulation

+ Sham

Device
Who is being recruted

Mental Disorders+9

+ Brain Diseases

+ Central Nervous System Diseases

From 50 to 75 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorUniversity of Florida
Study ContactShixie Jiang, MD
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 13, 2026

Actual date on which the first participant was enrolled.

This study focuses on older adults who have stayed in the intensive care unit (ICU) and experienced delirium, a sudden change in attention and awareness. Even after recovery, many survivors continue to face issues with memory, attention, and decision-making, which can affect daily activities. Currently, no specific treatments exist to improve these cognitive difficulties after ICU delirium. The study aims to test a noninvasive form of brain stimulation called intermittent theta burst stimulation (iTBS), which could potentially improve cognitive function in older ICU survivors who had delirium. The study targets the left dorsolateral prefrontal cortex, a brain region involved in attention and cognitive control, using a device cleared by the FDA for other conditions, like depression. The study involves up to 40 adults aged 50 to 75, approximately three months after an ICU stay with documented delirium. Participants will attend 11 visits over six weeks, including a baseline visit, 10 stimulation sessions over two weeks, and a one-month follow-up. Each stimulation session lasts about 15-20 minutes. Cognitive tests are conducted at baseline, immediately after the two-week stimulation period, and one month later. The primary outcome measure is the change in executive function, assessed using the Trail Making Test Part B. Additional tests evaluate attention, processing speed, language, and memory. The goals of this pilot study are to assess the feasibility, safety, and tolerability of the stimulation protocol and estimate the magnitude of cognitive changes. This research explores whether prefrontal neuromodulation could be a future strategy for cognitive recovery after ICU delirium.

Official TitlePrefrontal Theta Burst Stimulation to Improve Cognitive Impairment After ICU Delirium: A Randomized Sham-Controlled Pilot Trial
Principal SponsorUniversity of Florida
Study ContactShixie Jiang, MD
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBrain DiseasesCentral Nervous System DiseasesConfusionDeliriumDementiaNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurocognitive Disorders

Criteria

7 inclusion criteria required to participate
English fluency

Family or close friend for collateral

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

Show More Criteria

18 exclusion criteria prevent from participating
Current depressive disorder (Beck Depression Inventory score15 < 13)

Informant Questionnaire on Cognitive Decline in the Elderly16 (IQCODE) score >= 3.4 (suggesting prior cognitive decline)

Diagnosis of mild cognitive impairment or dementia (prior to delirium episode)

Schizophrenia

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Sham

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Florida Shands Hospital

Gainesville, United StatesOpen University of Florida Shands Hospital in Google Maps
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One Study Center