Ultrasound Stimulation for Altered Level of Consciousness
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo up to five visits involving LIFUP and MRI-based brain measurements targeting different brain regions
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants assigned to the MRS arm will also complete five visits, with a different brain region targeted at each visit. Each visit will include a pre-LIFUP baseline MRS acquisition, an excitatory LIFUP condition, a post-excitatory non-LIFUP MRS acquisition, an inhibitory LIFUP condition, and a post-inhibitory non-LIFUP MRS acquisition. Each MRS acquisition period will last approximately 13 minutes and will include approximately 5 minutes of glutamate plus glutamine measurement and 8 minutes of gamma-aminobutyric acid (GABA) measurement. The order of the excitatory and inhibitory LIFUP conditions will be randomized across participants.
Participants assigned to the fMRI arm will complete five visits, with a different brain region targeted at each visit. Each visit will include seven consecutive 10-minute scanning periods: one pre-LIFUP baseline fMRI scan, five fMRI scans conducted during LIFUP using five predefined combinations of duty cycle and pulse repetition frequency, and one post-LIFUP baseline fMRI scan. The five stimulation parameter combinations will be labeled Combination 1 through Combination 5. The order of the five parameter combinations will be randomized within each visit. The total planned scanning time for these seven periods is approximately 70 minutes, excluding structural imaging, participant positioning, transducer placement, safety checks, and other required study procedures.
Participants assigned to the glymphatic MRI arm will complete up to five visits, with a different prespecified brain region targeted at each visit. Tissue-to-fluid water exchange, velocity spectrum imaging, and cerebral perfusion using arterial spin labeling will be assessed before, during, and after LIFUP. The planned imaging periods total approximately 1.5 hours per visit, excluding participant positioning, structural imaging, transducer placement, safety checks, and other required study procedures.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Citations
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