What side effects are associated with this type of intervention?

Common treatments for memory loss that involve modulation of brain activity include transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). TMS can cause side effects such as headaches, scalp discomfort, and, rarely, seizures. ECT may lead to short-term memory loss, confusion, and physical side effects like muscle aches and headaches. Both treatments are generally considered safe when administered by trained professionals, but they do carry risks that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for memory loss, primarily focusing on pharmacological interventions such as cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine) for Alzheimer's disease. However, non-pharmacological treatments involving neuromodulation, such as Transcranial Magnetic Stimulation (TMS) and Electroconvulsive Therapy (ECT), have also been explored for their potential benefits in cognitive function and memory. While specific FDA approvals for Low Intensity Focused Ultrasound Pulsation (LIFUP) are not mentioned, these neuromodulation techniques share a similar goal of altering brain activity to improve cognitive outcomes.

What other types of research exist?

Promising novel alternatives to LIFUP for memory loss patients include: 1) Aducanumab, an antibody that reduces amyloid plaques in Alzheimer's disease, though its efficacy and safety are debated. 2) Memantine, which has been studied for its effects on frontotemporal dementia and Alzheimer's disease. 3) Selegiline, which has shown some neuropsychological benefits in dementia. 4) Tailored lighting interventions, which have been shown to improve sleep quality, rest-activity rhythms, and mood in dementia patients. 5) Cognitive Behavioral Therapy (CBT) and other non-pharmacological interventions aimed at improving sleep and cognitive function.

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Behavioural Intervention

Focused Ultrasound for Memory Loss (LIFUPMEMEMOT Trial)

N/A

Waitlist Available

Led By Taylor P Kuhn, PhD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English must be the dominant language

Must be between 35-65 years of age

Must not have

History of cancer or other neoplastic syndromes

History of major neurologic illness (e.g. epilepsy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-lifup and post-lifup at day 1 and day 15

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates whether using gentle sound waves to stimulate specific brain areas can help older adults improve their memory and emotional control. The technique aims to increase brain activity and blood flow in these regions.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a non-invasive method using ultrasound waves focused on specific brain areas and does not involve drugs or surgery, side effects are expected to be minimal. However, potential discomfort from the device placement may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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English is my primary language.

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I am between 35 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer or a related syndrome before.

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I have a history of a serious neurological condition like epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-lifup and post-lifup at day 1 and day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-lifup and post-lifup at day 1 and day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-lifup and post-lifup at day 1 and day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Perfusion in Regions Of Interest

Rey Auditory Verbal Learning Task

State Trait Anxiety Inventory - State (STAIS)

Secondary study objectives

Brief Visuospatial Memory Test

Emotional Reactivity Task

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Entorhinal Cortex first, then AmygdalaExperimental Treatment2 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 CortexExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Low Intensity Focused Ultrasound Pulsation to Entorhinal Cortex

2019

N/A

~30

Low Intensity Focused Ultrasound Pulsation to Amygdala

2019

N/A

~30

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Low Intensity Focused Ultrasound Pulsation (LIFUP) works by targeting specific brain regions to modulate neural activity, potentially enhancing memory and emotion regulation. This non-invasive technique can alter brain function by stimulating or inhibiting neuronal activity, which may help improve cognitive functions in patients with memory loss. Similar treatments include transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), which also aim to modulate brain activity to improve cognitive outcomes. These treatments are crucial for memory loss patients as they offer potential improvements in memory and cognitive function without the need for invasive procedures or systemic medications, thereby reducing the risk of side effects and improving quality of life.