Ultrasound for Cognitive Enhancement

Overseen By Miriam Freedman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Psychoactive medications

Disqualifiers: Neurological disorder, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 hour

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how Low-Intensity Focused Ultrasound (LIFU) can improve thinking and memory by targeting specific areas deep in the brain. The study seeks participants without neurological disorders, who are not taking psychoactive medications, and can undergo an fMRI scan. English speakers without major psychiatric conditions, except for depression or anxiety, may qualify. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research in cognitive enhancement.

Will I have to stop taking my current medications?

If you are taking any psychoactive medication, you will not be able to participate in the trial. The protocol requires that participants do not take these types of medications.

What prior data suggests that this ultrasound technique is safe for cognitive enhancement?

Research has shown that Low-Intensity Focused Ultrasound (LIFU) is generally safe for people. Studies have found that LIFU provides a non-invasive way to target specific brain areas without major risks. In past trials, participants reported only minor side effects, such as mild discomfort or slight headaches, which resolved quickly without lasting issues.

A recent review found that participants handled LIFU well. The study included detailed follow-ups, and most people experienced no serious side effects. This evidence suggests that LIFU could be a safe option for those considering participation in a clinical trial for cognitive enhancement. Always consult a healthcare professional to discuss personal risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Low-Intensity Focused Ultrasound (LIFU) for cognitive enhancement because it offers a non-invasive method to potentially boost brain function. Unlike traditional treatments, such as medications or cognitive therapies that often take weeks to show effects, LIFU uses sound waves to precisely target brain areas, which could lead to quicker improvements. This innovative approach aims to enhance neural activity without the side effects commonly associated with drugs, making it a promising alternative for improving cognitive performance.

What evidence suggests that Low-Intensity Focused Ultrasound is effective for cognitive enhancement?

Research has shown that Low-Intensity Focused Ultrasound (LIFU), which participants in this trial will receive, might help improve brain function. Studies have found that LIFU can boost activity in brain areas related to memory, such as the hippocampus. This increase in activity could lead to better thinking skills. One study found that LIFU helped grow new brain cells and improved memory in animals. These findings suggest that LIFU could potentially enhance thinking by targeting specific brain areas. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Bronstein

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in participating in a study examining the effects of Low-Intensity Focused Ultrasound (LIFU) on brain function. Specific eligibility criteria are not provided, but typically participants should be free from any neurological disorders or conditions that could affect cognition or safety during ultrasound treatment.

Inclusion Criteria

Speak English (as assessed by their ability to read/answer survey questions)

May be required to score in the appropriate range on self-report measures

I am 18 years old or older.

Exclusion Criteria

They have a neurological disorder which may impact their fMRI scan or cause their reaction to LIFU to differ from that of healthy adults

They are unable to undergo fMRI scanning due to a contraindication such as claustrophobia, unremovable piercings, pregnancy, the presence of medical devices such as pacemakers, or a movement or sleep disorder

Are pregnant, or may have reason to believe that they are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Low-Intensity Focused Ultrasound (LIFU) neuromodulation targeting deep brain regions

1 hour

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low-Intensity Focused Ultrasound

Trial Overview The study is testing the impact of LIFU, a non-invasive technique using sound waves to target deep brain areas, on cognitive abilities. The goal is to see if this method can safely enhance brain functions such as memory or attention in healthy subjects.

How Is the Trial Designed?

Group I: Low-Intensity Focused Ultrasound Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11700779/

A Comprehensive Review of Low-Intensity Focused ... The study showed a significant improvement in metabolic rate in regions of the hippocampus after sonication but only a minor change in any ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05417555?cond=Alzheimer%20Disease&term=focused%20ultrasound&aggFilters=status:not%20rec&rank=2

Low Intensity Focused Ultrasound for Mild Cognitive ... The goal of this study is to investigate whether Low Intensity Focused Ultrasound Pulsation (LIFUP) targeting a part of the brain involved in memory will ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1094715924006627

A Comprehensive Review of Low-Intensity Focused ... The study showed a significant improvement in metabolic rate in regions of the hippocampus after sonication but only a minor change in any cognitive test ...

4. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mdc3.70095

Cognitive Outcomes Following Second‐Sided Focused ... Among those whose medications were discontinued or reduced, there was no consistent pattern of improvement or decline in test scores.

5. nature.com nature.com/articles/s41380-021-01129-7

Low-intensity ultrasound restores long-term potentiation ... Focused ultrasound-induced blood-brain barrier opening improves adult hippocampal neurogenesis and cognitive function in a cholinergic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9599299/

Safety of Clinical Ultrasound Neuromodulation - PMC Transcranial ultrasound holds much potential as a safe, non-invasive modality for navigated neuromodulation, with low-intensity focused ultrasound (FUS) and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X24001293

Clinical recommendations for non-invasive ultrasound ... Adverse reactions or side effects of patients need to be recorded with evaluation tools and a follow-up can be conducted [3,9]. Previous data from low intensity ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04306601

NCT04306601 | Low-Intensity Focused Ultrasound on ... This study is a prospective single arm, open-label and explorative clinical trial to evaluate the therapeutic effect of recovery from DoC and safety of low- ...

9. nature.com nature.com/articles/s41598-020-62265-8

A retrospective qualitative report of symptoms and safety ... We provide an evaluation of the safety of LIFU for human neuromodulation through participant report and neurological assessment with a comparison of ...

10. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.825802/full

Low Intensity Focused Ultrasound for Non-invasive and ... This article describes an emerging non-invasive neuromodulatory technology, called low intensity focused ultrasound (LIFU).