Ultrasound Stimulation for Altered Level of Consciousness

AM
Overseen ByAmy McKinney
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 low-intensity focused ultrasound pulsation (LIFUP) to determine its effects on awareness and brain activity in individuals with altered consciousness. Researchers will employ various imaging techniques to observe LIFUP's impact on different brain regions. The trial includes different groups, with participants undergoing brain scans during and after LIFUP sessions. Right-handed, English-speaking individuals with normal vision (using contact lenses) and not on neurological medications may be suitable candidates. As an unphased trial, this study provides participants the chance to contribute to groundbreaking research in understanding consciousness.

What prior data suggests that low-intensity focused ultrasound pulsation (LIFUP) is safe for altering levels of consciousness?

Research has shown that low-intensity focused ultrasound pulsation (LIFUP) has been used safely in other studies. Although detailed safety data from past trials is limited, its use in various research settings supports its safety. If LIFUP were unsafe, it likely wouldn't be tested on humans at this stage. However, like any medical treatment, discussing possible risks with the trial team is important. They can provide specific information about how well LIFUP is tolerated and any side effects observed in earlier studies.12345

Why are researchers excited about this trial?

Most treatments for altered levels of consciousness, like medications or physical rehabilitation, work by addressing symptoms or stimulating the brain through non-invasive or invasive means. However, the Low-intensity Focused Ultrasound Pulsation (LIFUP) technique is unique because it uses targeted ultrasound waves to stimulate specific brain regions directly. This non-invasive method can precisely influence brain activity without surgery or medication, potentially leading to more immediate and controllable effects. Researchers are excited about this trial as it may pave the way for personalized and adaptable treatments that could enhance recovery or consciousness levels more effectively than current options.

What evidence suggests that this trial's treatments could be effective for altered level of consciousness?

Research has shown that low-intensity focused ultrasound pulsation (LIFUP) can stimulate the brain and may help individuals with consciousness issues become more aware. In this trial, participants will join different arms to explore LIFUP's effects using various imaging techniques. Studies have found that LIFUP can target specific brain areas, possibly increasing brain activity and energy use. Early results suggest that this method might awaken parts of the brain by altering brain cell communication. Some initial data indicate changes in brain scans and chemical signals, which could signify improved brain function. While more research is needed, LIFUP appears to be a promising non-invasive method to assist those with consciousness problems.

Who Is on the Research Team?

ZH

Zirui Huang

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with decreased or altered consciousness. People who cannot safely undergo MRI scans, have metal implants, or other conditions that make MRI unsafe are not eligible.

Inclusion Criteria

Participants must be right-handed, English-speaking, and capable of providing written informed consent
Participants must have a body mass index of less than 30
My vision is normal or corrected to normal with contact lenses.
See 1 more

Exclusion Criteria

Women of childbearing potential must have a negative study-funded pregnancy test before participation
Participants with history of significant head injury involving loss of consciousness
Participants with any contraindication to MRI scanning, including possible pregnancy, current breastfeeding, BMI greater than 30, metallic substances or implants in the body, claustrophobia, anxiety preventing MRI scanning
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo up to five visits involving LIFUP and MRI-based brain measurements targeting different brain regions

5 visits
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Low-intensity focused ultrasound pulsation (LIFUP)

Trial Overview

Researchers are testing how low-intensity focused ultrasound (LIFUP) affects brain awareness and metabolism. Participants receive LIFUP while their brains are monitored using different types of MRI scans.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: LIFUP-magnetic resonance spectroscopy (MRS)Experimental Treatment2 Interventions
Group II: LIFUP-fMRIExperimental Treatment2 Interventions
Group III: LIFUP-Glymphatic MRIExperimental Treatment2 Interventions

Find a Clinic Near You

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+

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