Focused Ultrasound for Memory Loss

(LIFUPMEMEMOT Trial)

Overseen By Natalie M Rotstein

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Head injury, Alcohol abuse, Psychiatric illness, Cancer, Neurologic illness, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how focused ultrasound, a type of sound wave treatment, affects brain activity in areas related to memory and emotion in older adults. The researchers aim to determine if this treatment can improve memory and assist with anxiety and emotion control. Participants will attend two visits where an MRI checks their brain activity, and the ultrasound treatment, specifically Low Intensity Focused Ultrasound Pulsation, is applied. The trial seeks right-handed adults who primarily speak English and wish to address memory or anxiety issues. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on non-invasive treatments for memory and anxiety issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this technique is safe for older adults?

Research has shown that Low Intensity Focused Ultrasound Pulsation (LIFUP) is generally safe for people. Studies have found that this method is well-tolerated when used to stimulate the brain, with most participants reporting few or no side effects. Some might experience mild discomfort or slight headaches, but these effects usually resolve quickly.

A thorough review of studies on both humans and animals supports the safety of using focused ultrasound for brain treatments, indicating that LIFUP does not cause serious side effects. This method is non-invasive, meaning it doesn't involve surgery or cutting into the body, making it less risky than other procedures.

Overall, LIFUP appears to be a safe option for improving memory or managing emotions. However, discussing any concerns with the trial team or a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Low Intensity Focused Ultrasound Pulsation (LIFUP) for memory loss because it offers a unique, non-invasive approach to treatment. Unlike current options like medications that target neurotransmitter levels or brain stimulation techniques that require surgical implants, LIFUP uses ultrasound waves delivered through the skull to stimulate specific brain regions directly. This innovative method allows for precise targeting of areas such as the entorhinal cortex and amygdala, which are critical for memory. By potentially enhancing brain function without invasive procedures or systemic drug effects, LIFUP could revolutionize how we treat memory-related conditions.

What evidence suggests that low intensity focused ultrasound pulsation is effective for memory loss?

This trial will study Low Intensity Focused Ultrasound Pulsation (LIFUP) as a method for addressing brain-related issues. Participants will receive LIFUP targeting either the entorhinal cortex first or the amygdala first, with the other area targeted two weeks later. Research has shown that LIFUP uses sound waves to stimulate specific brain regions and can reach these areas without surgery. Early studies suggest that focusing on the entorhinal cortex, a part of the brain involved in memory, might improve memory. LIFUP is also under study for its potential to affect anxiety and control emotions by targeting the amygdala. While more research is needed, these early findings offer hope that LIFUP could enhance brain functions related to memory and emotions. ^{1 6 7 8 9}

Who Is on the Research Team?

Taylor P Kuhn, PhD

Principal Investigator

UCLA Longevity Center

Are You a Good Fit for This Trial?

This trial is for right-handed English speakers aged 35-65 with learning disabilities, memory loss, or cognitive issues. It's not suitable for those with MRI contraindications like metal implants, major psychiatric or neurological illnesses, significant head injuries, alcohol/substance abuse history, or cancer.

Inclusion Criteria

English is my primary language.

You must be someone who primarily uses their right hand for tasks.

I am between 35 and 65 years old.

Exclusion Criteria

You have had a head injury serious enough to need medical care.

You have a history of drinking too much or being addicted to alcohol.

History of major psychiatric illness requiring treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LIFUP to the amygdala and entorhinal cortex in a crossover design

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low Intensity Focused Ultrasound Pulsation
• SHAM Ultrasound

Trial Overview The study tests if Low Intensity Focused Ultrasound Pulsation (LIFUP) can improve memory by stimulating the brain's medial temporal lobe non-invasively. Participants will be randomly assigned to receive either LIFUP or a SHAM ultrasound that mimics treatment without real effects.

How Is the Trial Designed?

Group I: Entorhinal Cortex first, then Amygdala Experimental Treatment 2 Interventions

Low Intensity focused ultrasound pulsation (LIFUP) will be administered to the entorhinal cortex while participants are in the MRI scanner. Then, 2 weeks later, amygdala LIFUP will be administered.

Group II: Amygdala first, then Entorhinal Cortex Experimental Treatment 2 Interventions

Low Intensity focused ultrasound pulsation (LIFUP) will be administered to the amygdala while participants are in the MRI scanner. Then, 2 weeks later, entorhinal cortex LIFUP will be administered.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

Focused ultrasound (FUS) combined with microbubbles has been shown to safely open the blood-brain barrier in animal studies, allowing therapeutic agents to enter the brain and potentially improve cognitive function in Alzheimer's disease.

Human studies indicate that repeated FUS treatments are well tolerated with minimal side effects, and they may enhance brain blood flow and neural function, which is associated with cognitive improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Applications of Focused Ultrasound (FUS) in Alzheimer's Disease Treatment: A Systematic Review on Both Animal and Human Studies. Liu, X., Naomi, SSM., Sharon, WL., et al.[2021]

In a phase I safety trial involving five patients with early to moderate Alzheimer's disease, focused ultrasound successfully and safely opened the blood-brain barrier without causing serious adverse events or worsening cognitive function over three months.

Although the procedure was safe, exploratory analysis showed no significant changes in beta-amyloid levels post-treatment, indicating that while the method is feasible, further research is needed to assess its efficacy in reducing Alzheimer's pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood-brain barrier opening in Alzheimer's disease using MR-guided focused ultrasound. Lipsman, N., Meng, Y., Bethune, AJ., et al.[2022]

Androgen deprivation therapy (ADT) is a key treatment for prostate cancer, effective throughout the disease course, including in metastatic, localized, and recurrent cases.

While ADT is beneficial, it comes with significant side effects such as osteoporosis, increased fracture risk, diabetes, cardiovascular issues, and sexual dysfunction, necessitating a multidisciplinary approach to patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Androgen deprivation therapy: indications, methods of utilization, side effects and their management. Magee, DE., Singal, RK.[2021]

Citations

1. 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 ...

2. reporter.nih.gov reporter.nih.gov/project-details/11171355

Project Details Low intensity focused ultrasound pulsation (LIFUP) uses acoustic energy waves with frequencies higher than humans can hear to penetrate the skull to effect ...

3. uclahealth.org uclahealth.org/clinical-trials/low-intensity-focused-ultrasound-mild-cognitive-impairment

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 have ...

4. clinicaltrial.be clinicaltrial.be/en/details/428?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Low Intensity Focused Ultrasound for Mild Cognitive Impai... This is a proof of concept trial of Low Intensity Focused Ultrasound Pulsation (LIFUP) targeting the entorhinal cortex in patients with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03782194

Low Intensity Focused Ultrasound for Learning and ... The goal of this clinical trial is to investigate the impact of low intensity focused ultrasound pulsation (LIFUP) to two different brain regions.

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

A Comprehensive Review of Low-Intensity Focused ... Safety of transcranial focused ultrasound stimulation: a systematic review of the state of knowledge from both human and animal studies ...

7. 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 ...

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

A Comprehensive Review of Low-Intensity Focused ... Safety of transcranial focused ultrasound stimulation: a systematic review of the state of knowledge from both human and animal studies. Brain Stimul, 12 ...

9. 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 ...