40 Participants NeededMy employer runs this trial

Theta Burst Stimulation for Cognitive Impairment After Delirium

SJ
Overseen ByShixie Jiang, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve thinking and focus in older adults who experienced delirium (a sudden change in mental state) after an ICU stay. It tests intermittent theta burst stimulation (iTBS), a type of brain stimulation using magnetic pulses to target brain areas related to attention and decision-making. The trial includes participants who had ICU delirium about three months ago, can speak English, and live in the community. By assessing the safety and effectiveness of this treatment, researchers aim to help people recover cognitive skills after ICU stays. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance recovery options for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this brain stimulation technique is safe for improving cognitive function after ICU delirium?

Studies have shown that intermittent theta burst stimulation (iTBS) is generally safe. This brain stimulation method uses magnetic pulses and has been safely applied to treat conditions like depression. The U.S. Food and Drug Administration (FDA) has approved iTBS for depression, confirming its safety.

A small study found that iTBS can enhance thinking and memory in people with mild cognitive impairment and Alzheimer's disease, without serious side effects. Another study involving older adults reported no major safety issues.

While iTBS appears promising, its use for improving thinking and memory after ICU delirium remains under investigation. However, safety data from similar applications is encouraging.12345

Why are researchers excited about this trial?

Unlike the standard of care for cognitive impairment after delirium, which often involves medications and cognitive therapy, intermittent theta burst stimulation (iTBS) offers a non-invasive brain stimulation technique. Researchers are excited about iTBS because it uses rapid bursts of magnetic pulses to potentially enhance brain function and improve cognitive outcomes. This technique targets specific brain regions more directly and may offer quicker results compared to traditional treatments. Additionally, iTBS could provide a novel option for patients who are resistant to or cannot tolerate medication-based therapies.

What evidence suggests that intermittent theta burst stimulation could be effective for cognitive impairment after delirium?

This trial will compare intermittent theta burst stimulation (iTBS) with a sham treatment to evaluate its effectiveness for cognitive impairment following delirium. Studies have shown that iTBS can enhance thinking skills, with research indicating its effectiveness in improving abilities like attention and memory in individuals with mild cognitive impairment and Alzheimer's disease. Specifically, cognitive tests have demonstrated significant improvements after using iTBS, with strong evidence supporting its role in enhancing brain function. Although researchers are still studying this treatment for cognitive issues after delirium, early results suggest it might aid recovery. Overall, the safety and promising outcomes from other conditions offer hope that iTBS could be beneficial here as well.12567

Are You a Good Fit for This Trial?

This trial is for adults aged 50-75 who had delirium during an ICU stay about three months ago, live in the community, speak English, and have mild cognitive difficulties but no prior dementia or major neurological/psychiatric conditions. People with certain implants or unstable heart disease can't join.

Inclusion Criteria

English fluency
I was discharged from the ICU about 3 months ago.
I live independently in the community.
See 4 more

Exclusion Criteria

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)
Pregnancy (negative urine or serum b-HCG or history of prior surgical sterilization or post-menopausal status [12 months or more of amenorrhea])
I do not have recent or severe heart problems.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline cognitive testing and initial assessment

1 day
1 visit (in-person)

Treatment

Participants receive intermittent theta burst stimulation (iTBS) sessions

2 weeks
10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Intermittent Theta Burst Stimulation

Trial Overview

The study tests whether a noninvasive brain stimulation called intermittent theta burst stimulation (iTBS) can safely improve thinking skills after ICU delirium. Participants are randomly assigned to receive either real iTBS or a sham (inactive) treatment over two weeks.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Intermittent theta burst stimulationActive Control1 Intervention
Group II: ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Citations

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