Ultrasonic Deep Brain Stimulation for Mental Function

Overseen By Amy McKinney

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Neurological, Cardiovascular, Pulmonary, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 session

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores brain function under varying levels of anesthesia using two common drugs, propofol and dexmedetomidine. Researchers are testing whether targeted ultrasound, known as Ultrasonic Deep Brain Stimulation, can stimulate specific brain regions to help patients regain consciousness faster. Participants will undergo brain imaging to track changes during the process. Ideal candidates for this trial are healthy, right-handed adults with a BMI under 30 who speak English and have no history of certain medical conditions or metal implants. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research on brain function and consciousness recovery.

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

The trial information does not specify if you need to stop taking your current medications. However, it does exclude participants with certain medical conditions and those with a history of drug use, so it's best to discuss your specific medications with the trial organizers.

What prior data suggests that ultrasonic deep brain stimulation is safe for mental function studies?

Research has shown that using ultrasound to stimulate specific brain areas is generally safe. Studies have found that low-intensity focused ultrasound (LIFUP) is well-tolerated when applied to various brain regions, such as the dorsolateral prefrontal cortex, anterior insular cortex, and central thalamus.

Research with healthy individuals supports the safety of transcranial focused ultrasound (tFUS), a similar technique, indicating it doesn't cause lasting harm. One study provided the first human evidence that deep transcranial ultrasound stimulation is safe and effective for non-invasive brain activity changes.

Additionally, safety reviews for tFUS highlight its potential as a non-invasive and safe method to target brain areas. While no treatment is without risks, current data supports ultrasonic brain stimulation as a safe option for exploring mental functions during anesthesia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ultrasonic deep brain stimulation because it offers a non-invasive way to potentially improve mental function. Unlike traditional treatments that often involve medication or surgery, this method uses sound waves to target specific brain regions, such as the dorsolateral prefrontal cortex, anterior insular cortex, and central thalamus. This precision targeting could lead to more effective results with fewer side effects. Additionally, the use of ultrasonic waves allows for real-time adjustments during treatment, potentially enhancing its effectiveness further.

What evidence suggests that ultrasonic deep brain stimulation could be effective for mental function during anesthesia?

This trial will explore the effects of ultrasonic deep brain stimulation on mental function. Research has shown that ultrasonic deep brain stimulation can accurately target and activate specific brain areas. This technique safely and effectively influences brain activity without surgery. Studies have found that it can improve thinking skills, enhancing mental clarity and focus. Early results also suggest it might help people wake up faster after anesthesia. Overall, researchers are studying ultrasonic deep brain stimulation for its potential to boost brain function in various situations. Participants in this trial will receive different combinations of anesthetics and brain region pulsations, such as Propofol or Dexmedetomidine with pulsation of the dorsolateral prefrontal cortex, anterior insular cortex, or central thalamus. ^{6 7 8 9 10}

Who Is on the Research Team?

Anthony Hudetz

Principal Investigator

University of Michigan

Zirui Huang

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals who are undergoing anesthesia and will be monitored to understand mental functions at different sedation levels. Specific eligibility criteria details were not provided, so it's unclear who exactly can participate.

Inclusion Criteria

English speakers

Body mass index (BMI) less than 30

I am in good health as per the ASA-1 status.

Exclusion Criteria

Medical contraindication to MRI scanning; unable to undergo MRI scanning due to possible pregnancy or currently breastfeeding

BMI > 30

Presence of metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease; or intracranial structural abnormality on T1-weighted MRI scans

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 pulsation (LIFUP) while under anesthesia with propofol or dexmedetomidine, and undergo functional Magnetic Resonance Imaging (fMRI) to study brain activity

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the treatment session

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasonic Deep Brain Stimulation

Trial Overview The study tests how the brain responds under anesthesia using two drugs (propofol and dexmedetomidine) combined with ultrasonic pulses in three brain areas (DLPFC, AIC, CT) during fMRI scans to observe thinking processes and recovery of consciousness.

How Is the Trial Designed?

Group I: Propofol & Dorsolateral prefrontal cortex (DLPFC) pulsation Experimental Treatment 2 Interventions

Group II: Propofol & Central thalamus (CT) pulsation Experimental Treatment 2 Interventions

Group III: Propofol & Anterior insular cortex (AIC) pulsation Experimental Treatment 0 Interventions

Group IV: Dexmedetomidine & DLPFC pulsation Experimental Treatment 2 Interventions

Group V: Dexmedetomidine & CT pulsation Experimental Treatment 2 Interventions

Group VI: Dexmedetomidine & AIC pulsation Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6397644/

Deep brain stimulation: current challenges and future directions This Review considers how DBS has facilitated advances in our understanding of how circuit malfunction can lead to brain disorders and outlines the key unmet ...

2. nature.com nature.com/articles/s41467-025-63020-1

Ultrasound system for precise neuromodulation of human ... Long-term outcomes of deep brain stimulation in Parkinson disease. Nat. Rev. Neurol. 15, 234–242 (2019). Article PubMed Google Scholar.

3. 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

4. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X25000993

Deep transcranial ultrasound stimulation using ... This study provides first-in-human evidence of the potential of mTUS as a precise, safe and effective non-invasive neuromodulation technique.

5. jmedicalcasereports.biomedcentral.com jmedicalcasereports.biomedcentral.com/articles/10.1186/s13256-023-04194-4

Durable effects of deep brain ultrasonic neuromodulation ... This case illustrates the potential for ultrasonic neuromodulation to precisely engage deep neural circuits and to trigger a durable therapeutic reset of those ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07221539

Restoration of Consciousness With Ultrasonic Deep Brain ... The purpose of this study is to see if mental functions take place during different levels of anesthesia using two commonly used drug (propofol ...

7. 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 ...

8. 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 ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925002612

Insula Deep Brain Stimulation for Neuropathic Pain Individuals who had been true responders to the PSI deep-rTMS (ie, had ≥50% pain intensity reduction after real stimulation but not with sham) ...

10. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/45/NCT05495945/Prot_SAP_000.pdf

Ultrasonic Deep Brain Stimulation During Anesthetic ... The anterior insula cortex (AIC) gates conscious contents and regulates brain network switches between dorsal attention (associated with external awareness) ...