University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT07840521
This research is studying changes in awareness and metabolism in the brain that may take place in various brain regions stimulated with ultrasound (low-intensity focused ultrasound pulsation or LIFUP) while undergoing magnetic resonance imaging (MRI)-based brain measurements.
Trial opening soon.
Get Notified18 year–40 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
This study examines the effects of low-intensity focused ultrasound pulsation (LIFUP) on conscious perception and brain physiology in healthy adults using functional Magnetic resonance imaging (MRI), magnetic resonance spectroscopy, or multimodal glymphatic MRI. Participants are assigned by the study team to one of three arms, each involving up to five visits targeting different prespecified brain regions. Participants perform a visual perception task during imaging, with measurements obtained before, during, and after LIFUP. After completing their initially assigned arm, participants may re-enroll in another arm or for a repeat visit following re-screening and new informed consent.
Randomization applies to the order of procedures within each arm, not to assignment of participants among the three arms. The order in which the five brain regions are targeted will be randomized across participants in all three experimental arms
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LIFUP will be used to stimulate specific brain regions and assess their causal involvement in the control of conscious state and contents.
Whole-brain functional images will be acquired using a multiband gradient-echo echo-planar imaging sequence with the following parameters: 60 slices, repetition time (TR) = 800 ms, echo time (TE) = 30 ms, flip angle = 52°, multiband acceleration factor = 6, slice thickness = 2.4 mm, in-plane resolution = 2.4 × 2.4 mm, FOV = 216 × 216 mm, and image matrix = 90 × 90. MRI acquisition and associated study procedures will be completed within a scanning visit lasting no more than approximately 2 hours.
Single-voxel proton magnetic resonance spectroscopy will be performed. A nominal 15 × 15 × 10 mm spectroscopy voxel will be positioned at the prespecified brain target using the participant's anatomical MRI. Glutamate plus glutamine (Glx) will be measured using a short-echo-time spectroscopy sequence with an acquisition time of approximately 5 minutes. GABA will be measured using an edited spectroscopy sequence with an acquisition time of approximately 8 minutes. An unsuppressed water-reference scan will also be acquired for signal correction and metabolite quantification. Voxel placement, shimming, and other sequence parameters may be adjusted slightly based on target anatomy, scanner requirements, and data quality while maintaining the planned procedures and approximate acquisition times.
The study team will collect three separate measurements related to glymphatic function. (i) Multi-delay pseudo-continuous arterial spin labeling (PCASL) MRI with a 3D stack of spirals (SOS) gradient and spin echo (GRASE) read-out. Labeling durations from 500 to 2000 ms, TR = 6 sec., background suppression. FOV = 24 cm with 3x3x5 mm resolution. (ii) Tissue-to-fluid Water exchange rate using T2 selective saturation labeling pulses using the same resolution parameters. (iii) Velocity Spectrum Imaging using velocity selective preparation pulses followed by spherical spiral projection imaging (FOV = 24 cm, velocity bandwidth = [-1, 1] cm/s, isotropic spatial resolution = 3.5 mm).
Time frame: Approximately 70 minutes
Changes in task-evoked blood oxygen level-dependent responses to visual stimuli will be measured using functional MRI before, during, and after LIFUP across the five stimulation parameter conditions.
Time frame: Approximately 65-75 minutes
The perceptual response criterion, c, will be calculated from participants' recognition responses using Signal Detection Theory to quantify their tendency to report conscious recognition of a visual stimulus.
For each scanning session, the study team will calculate sensitivity (d') and criterion (c) using subjective reports of recognition as "yes" or "no".
Time frame: Approximately 75 minutes
Perceptual sensitivity, d', will be calculated from participants' visual discrimination responses using Signal Detection Theory to quantify their ability to distinguish intact object images from control stimuli.
For each scanning session, the study team will calculate sensitivity (d') and criterion (c) using subjective reports of recognition as "yes" or "no".
Trial opening soon.
Get NotifiedUniversity of Michigan
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06003127
Anesthesia, Consciousness Disorders
Boston, Massachusetts, United States
View Trial DetailsNCT03814356
Anoxic Brain Injury, Brain Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT07145697
Consciousness Disorders, Consciousness, Level Altered
Guangzhou, Guangdong, China
View Trial DetailsNCT06503016
Airway Disease, Arrhythmias, Cardiac
Milan, Italy
View Trial Details