20 Participants Needed

Transcranial Ultrasound Stimulation for Alzheimer's Disease

(NDD-01 Trial)

TK
JS
Overseen ByJay Sanguinetti, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called transcranial ultrasound stimulation, a non-invasive therapy, to aid individuals with Alzheimer's and similar brain conditions. The goal is to determine if this treatment can safely enhance brain function, memory, behavior, and overall quality of life. Suitable candidates for this trial include those diagnosed with Alzheimer's, Parkinson's, or mild cognitive issues, who are stable and can read English. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve future treatments for brain conditions.

Do I need to stop taking my current medications for the trial?

The trial team will review your current medications to ensure they don't increase the risk of seizures or interact with the study. They will decide if you need to stop any medications.

What prior data suggests that transcranial ultrasound stimulation is safe for Alzheimer's patients?

Research has shown that transcranial ultrasound stimulation is generally well-tolerated by patients. One study found that it improved thinking skills and brain function, offering potential benefits without major safety concerns. Another source highlights that this technique is non-invasive, meaning it doesn't involve surgery and is considered safe to use. These findings suggest that the treatment is safe for people with Alzheimer's disease, with no significant harmful effects reported.12345

Why are researchers excited about this trial?

Researchers are excited about transcranial ultrasound stimulation for Alzheimer's disease because it offers a novel, non-invasive way to potentially slow or alter the disease's progression. Unlike current treatments, which mainly focus on managing symptoms through medications like cholinesterase inhibitors and memantine, this technique uses focused ultrasound waves to target specific brain regions involved in Alzheimer's pathology. This approach could lead to more precise modulation of brain activity and possibly impact the underlying disease mechanisms, which is a significant departure from existing symptom-focused therapies.

What evidence suggests that transcranial ultrasound stimulation is effective for Alzheimer's disease?

Studies have shown that using sound waves on the head, known as transcranial ultrasound stimulation (TUS), may help people with Alzheimer's disease by improving brain function. Research indicates that TUS can reach deep brain areas, such as the hippocampus, which is crucial for memory. In one study, patients demonstrated better thinking abilities after TUS treatment. Another study found that TUS might help the brain use energy more efficiently, enhancing cognitive skills. These early findings suggest TUS could be a promising approach for Alzheimer's, although more research is needed to confirm its long-term benefits. Participants in this trial will receive open-label transcranial focused ultrasound neuromodulation targeting a brain region involved in disease pathology.12367

Who Is on the Research Team?

JS

Jay Sanguinetti, PhD

Principal Investigator

Sanmai Technologies, PBC

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with Alzheimer's, Parkinson's, or mild cognitive impairment who can read English and are medically stable. They must not have psychiatric conditions like OCD or bipolar disorder, drug/alcohol addiction, significant neurological issues unrelated to their diagnosis, metal implants incompatible with TUS/MRI, uncontrolled heart conditions, recent cancer history (less than 5 years remission), or a high risk of seizures.

Inclusion Criteria

Ability to read and understand English
Must be medically stable as determined by investigators
I am between 18 and 80 years old.
See 2 more

Exclusion Criteria

Psychiatric Conditions: individuals diagnosed with obsessive-compulsive disorder, psychosis, and/or bipolar disorder. Final eligibility will be determined after a thorough evaluation by the study clinicians
No other recreational drug use for at least 1 month prior to first treatment session
Current pregnancy
See 13 more

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 neuromodulation targeting a brain region involved in disease pathology

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Ultrasound Stimulation
Trial Overview The study tests transcranial focused ultrasound neuromodulation on patients with neurodegenerative diseases to see if it improves brain function and quality of life. It involves administering ultrasound stimulation to areas affected by the disease.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Open label transcranial focused ultrasound neuromodulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanmai Technologies PBC dba Sanmai

Lead Sponsor

Trials
1
Recruited
100+

Acacia Research

Collaborator

University of New Mexico

Collaborator

Trials
393
Recruited
3,526,000+

The Regenesis Project

Collaborator

BrainMind

Collaborator

Citations

Ultrasound Neuromodulation With Transcranial Pulse ...This randomized clinical trial examines the effect of ultrasound neuromodulation using transcranial pulse stimulation on cognitive outcomes ...
Transcranial ultrasound stimulation in neuromodulationShort-term efficacy of transcranial focused ultrasound to the Hippocampus in Alzheimer's disease: a preliminary study. J Pers Med. 12:250 ...
Safety and efficacy of transcranial ultrasound stimulation ...Transcranial ultrasound stimulation (TUS) may benefit patients with Alzheimer's disease (AD) through neuromodulation. · AD patients treated with ...
A panoramic review of transcranial focused ultrasound ...A key advantage of tFUS is its ability to penetrate the skull and concentrate energy on deep brain structures, potentially reaching subcortical ...
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 ...
Alzheimer's DiseaseLearn about clinical trials that are investigating the use of focused ultrasound to treat Alzheimer's Disease.
Transcranial Focused Ultrasound: A New Frontier for Non- ...The results showed that individuals receiving active tFUS exhibited decreased activation of the amygdala during a fear-inducing task, as ...
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