Theta Burst Stimulation for Cognitive Impairment After Delirium
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.12345Why 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline cognitive testing and initial assessment
Treatment
Participants receive intermittent theta burst stimulation (iTBS) sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Citations
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A pilot randomized controlled double-blind trial of intermittent ...
Noninvasive brain stimulation using repetitive transcranial magnetic stimulation (rTMS) has demonstrated promise in improving cognition in MCI and AD.
A randomized controlled study on intermittent theta pulse ...
This study provides robust evidence that iTBS is a safe and effective adjunctive intervention for improving cognitive function and quality of ...
Prefrontal Theta Burst Stimulation for Cognitive ...
This study aims to evaluate the effectiveness of Prefrontal Theta Burst Stimulation as a treatment to improve cognitive function in individuals who have ...
Effect of intermittent theta burst stimulation of the left ...
Significant Time effects were observed for all cognitive and biochemical measures (p < 0.001), indicating overall improvement after intervention. Significant ...
The potential for synergistic effect of non-invasive brain ...
Beyond affective symptoms, depression is frequently associated with cognitive impairment that persists post-remission in 39–44% of cases. Non-invasive brain ...
Neuroplasticity underlying prolonged intermittent theta-burst ...
To investigate the safety, feasibility, and efficacy of prolonged intermittent theta burst stimulation (piTBS) in patients with disorders of ...
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