Transcranial Focused Ultrasound for Dementia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurological Associates of West Los Angeles

Disqualifiers: Major depressive disorder, advanced organ failure, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with mild cognitive issues or dementia using transcranial focused ultrasound, which uses sound waves directed at the brain. Researchers aim to determine if this technique is safe for long-term use and if it can improve memory or thinking skills. Suitable participants have mild memory problems, such as mild cognitive impairment, and brain scans indicating a neurodegenerative disease, but not if their memory issues stem from sudden causes like illness or injury. As an unphased trial, participants can contribute to groundbreaking research that may lead to new treatment options for cognitive impairments.

Do I need to stop my current medications for the 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 transcranial focused ultrasound is safe for treating dementia?

Research shows that transcranial focused ultrasound (tFUS) is generally safe. Studies indicate that people usually tolerate this technique well. One study found that using low-intensity tFUS on the brain's hippocampus might even boost brain function without causing harm. Another review supported these findings, noting that tFUS is considered safe enough for ongoing clinical trials.

Additionally, researchers have used tFUS to temporarily open the blood-brain barrier, a protective layer around the brain, without causing serious side effects. This makes it a promising option for treating conditions like dementia. Overall, existing research suggests that tFUS is safe for use in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial focused ultrasound for dementia because it offers a non-invasive approach to potentially improve brain function. Unlike traditional treatments that mostly involve medications to manage symptoms, this technique uses sound waves to target specific brain areas, which might help in alleviating the underlying issues of dementia. This method could reduce reliance on drugs and minimize side effects, making it a promising alternative for patients.

What evidence suggests that transcranial focused ultrasound is effective for dementia?

Research has shown that focused ultrasound on the brain might help people with mild memory problems or dementia think more clearly. In one study, 62.5% of patients improved their thinking scores, and 87% maintained or enhanced their fine motor skills. Another study suggested that this treatment might also improve how the brain uses energy, which is important for memory and thinking. Overall, these studies offer hope that this technology could address memory and thinking issues related to dementia. Participants in this trial will receive transcranial focused ultrasound to explore its potential benefits further. ^{1 2 4 6 7}

Who Is on the Research Team?

Sheldon E Jordan, M.D.

Principal Investigator

Neurology Management Associates

Are You a Good Fit for This Trial?

This trial is for people with mild cognitive impairment or early-stage dementia, evidenced by specific brain imaging markers. Participants must be able to give informed consent and lie still in a calm environment. Those with cognitive issues due to acute illness, scalp conditions, severe physical illnesses, major depression, or vascular dementia are excluded.

Inclusion Criteria

I have mild memory or thinking problems.

You have clear signs of a neurodegenerative condition in your brain scans.

Exclusion Criteria

I have been diagnosed with major depressive disorder.

I am unable to understand and give consent for treatment.

My cognitive issues are due to a recent illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial focused ultrasound treatment aimed at the hippocampus or the putamen and substantia nigra, depending on the condition. Treatment includes 8 sessions of focused ultrasound.

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using measures such as the Quick Dementia Rating Scale and Montreal Cognitive Assessment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Focused Ultrasound

Trial Overview The study tests the safety and initial effectiveness of transcranial focused ultrasound as a treatment for neurodegenerative dementias like Alzheimer's and Parkinson's disease over an extended period.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

All patients enrolled will receive transcranial focused ultrasound. Target location is dependent on patient condition.

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials

26

Recruited

4,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8446491/

A pilot clinical study of low-intensity transcranial focused ... These results suggest that hippocampal sonication with low-intensity tFUS may have beneficial effects on cerebral glucose metabolism and cognitive function in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6700262/

Focused transcranial ultrasound for treatment of ... Of all, 62.5% of patients had one or more improved cognitive scores without data incongruence, 87% had stable or improved fine motor scores, and 87.5% had ...

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

A Comprehensive Review of Low-Intensity Focused ... In this study, we provide a review of the most recent LIFU literature covering three key domains: 1) the history of focused ultrasound technology, ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2830764

Ultrasound Neuromodulation With Transcranial Pulse ... This randomized clinical trial examines the effect of ultrasound neuromodulation using transcranial pulse stimulation on cognitive outcomes ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/17434440.2025.2563618?src=

Full article: Focused transcranial ultrasound stimulation High-intensity fTUS leads to heat-induced thermoablation, which has shown efficacy in treating essential tremor and tremor-dominant Parkinson's disease, with ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf15/P150038S006B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The treatment effect using Exablate Neuro Type 1.0 and Type 1.1 is achieved by accurately guiding the focus of the ultrasound energy to the target region. The ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa2308719

Ultrasound Blood–Brain Barrier Opening and Aducanumab ... Low-intensity focused ultrasound guided by magnetic resonance imaging (MRI) has been shown to reversibly open the blood–brain barrier in ...