Low Intensity Focused Ultrasound for Learning and Memory (LIFUPMEM)
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|ClinicalTrials.gov Identifier: NCT03717922|
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Diseases Memory Disorders Learning Disabilities Cognitive Impairment||Device: Low Intensity Focused Ultrasound Pulsation Device: SHAM Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Participants will be blinded to whether or not the LIFUP transducer is on and, when on, what parameters are used. The investigator collecting the neuropsychological data will be blinded to which condition (LIFUP, sham) the participant completed during the session. The statistical analysts for both the neuropsychological and neuroimaging data will also be blinded to condition.|
|Official Title:||Low Intensity Focused Ultrasound of Medial Temporal Lobe Regions for the Improvement of Learning and Memory|
|Estimated Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||October 31, 2024|
Experimental: MRI ultrasound sonication
Low Intensity focused ultrasound pulsation will be administered to participants while they are in the fMRI scanner. Functional and perfusion MR data will be collected before and after the sonication to allow for comparisons and investigation of pre and post sonication functional activation and connectivity.
Device: Low Intensity Focused Ultrasound Pulsation
BOLD fMRI will be collected during two conditions (given that the timecourse of LIFUP related changes is unknown, sham will always precede the LIFUP condition). LIFUP (previously used in primary sensory cortices will be administered in 75 sonifications at 210 KHz frequency with pulse repetition frequency of 500Hz, 35mW/cm2, sonification duration 0.5s with 7s inter-stimulation intervals. Sham LIFUP will involve the same procedures (e.g. participant provided the same instructions) except the sonification will not occur.
Sham Comparator: Sham Ultrasound
While in the fMRI scanner, participants will have the ultrasound transducer attached to their head in the same manner as during the actual ultrasound sonication. However, during this portion of the experiment, the transducer will not be turned on. Previous, published experiments indicate that participants are unable to differentiate between when the transducer is on and off.
Device: SHAM Ultrasound
BOLD fMRI will be collected while the ultrasound trandsducer is not turned on. Participants are unable to tell whether the transducer is on or off.
- Rey Auditory Verbal Learning Task [ Time Frame: Day 1 ]Number of words learned across each learning trial and number of words recalled during the delayed recall trial will be compared before and after sonication for each participant in a within subject design.
- BOLD fMRI Signal in Entorhinal Cortex [ Time Frame: Day 1 ]BOLD data will be collected in real-time during the ultrasound sonication, which occurs in on-off blocks. Analyses will assess the statistical relationship between BOLD signal in the brain and the time series (on vs off) of the ultrasound sonication.
- Perfusion ASL fMRI Signal throughout Brain [ Time Frame: Day 1 ]Perfusion ASL fMRI data will be collected before and after sonication. Analyses will assess the statistical relationship between ASL signal throughout the brain pre and post sonication in a within subject repeated measures design.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717922
|Contact: Taylor Kuhn, PhDfirstname.lastname@example.org|
|Contact: Malina Beatriceemail@example.com|