Low Intensity Focused Ultrasound for Mild Cognitive Impairment and Mild Alzheimer's Disease
NCT ID: NCT05417555
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2022-09-01
2026-07-31
Brief Summary
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The main questions the study seeks to answer are:
1. Can LIFUP increase brain activity in the targeted area?
2. Can LIFUP improve memory in people with MCI and mild AD?
3. Can LIFUP improve connectivity of memory networks in the brain?
Participants in this study will complete MRIs and memory testing, and receive Low Intensity Focused Ultrasound to a part of their brain involved in memory (the entorhinal cortex).
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Detailed Description
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At the start of the study, you will be randomly assigned to one of four different groups that determines the amount of LIFUP stimulation you will receive. You have an equal chance of being assigned to each group. Participants in one of the three active stimulation groups will receive either 1 dose, 2 doses, or 3 doses of LIFUP at their second in-person session, and will receive the same dose again at their third in-person session. Participants in the placebo group will receive no LIFUP stimulation at either MRI/LIFUP session (in-person visits 2 and 3). However, if at the end of our study, the treatment has been shown to be effective, and you were a placebo subject, we will offer you a free session using the most effective dose.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LIFUP Dose Group 1
Administration of low intensity focused ultrasound (LIFUP) dose level 1 to the entorhinal cortex.
Low-Intensity Focused Ultrasound Pulsation (LIFUP)
Low intensity focused ultrasound pulsation will be administered to the left entorhinal cortex at 650kHz, ispta.3 720mW/cm, pulse repetition frequency 100Hz, duty cycle 50%, duration 30s with 30s spacing between sonications, 6 sonications per dose (participants receive 0, 1, 2 or 3 doses depending on group assignment)
LIFUP Dose Group 2
Administration of low intensity focused ultrasound (LIFUP) dose level 2 to the entorhinal cortex.
Low-Intensity Focused Ultrasound Pulsation (LIFUP)
Low intensity focused ultrasound pulsation will be administered to the left entorhinal cortex at 650kHz, ispta.3 720mW/cm, pulse repetition frequency 100Hz, duty cycle 50%, duration 30s with 30s spacing between sonications, 6 sonications per dose (participants receive 0, 1, 2 or 3 doses depending on group assignment)
LIFUP Dose Group 3
Administration of low intensity focused ultrasound (LIFUP) dose level 3 to the entorhinal cortex.
Low-Intensity Focused Ultrasound Pulsation (LIFUP)
Low intensity focused ultrasound pulsation will be administered to the left entorhinal cortex at 650kHz, ispta.3 720mW/cm, pulse repetition frequency 100Hz, duty cycle 50%, duration 30s with 30s spacing between sonications, 6 sonications per dose (participants receive 0, 1, 2 or 3 doses depending on group assignment)
Sham LIFUP
No administration of LIFUP. The device will be affixed to the user's head but not turned on.
Additionally, if at the end of the study, the treatment has been shown to be effective, placebo subjects will be offered a free session using the optimally effective dose, if they consented to being contacted for this purpose.
Low-Intensity Focused Ultrasound Pulsation (LIFUP)
Low intensity focused ultrasound pulsation will be administered to the left entorhinal cortex at 650kHz, ispta.3 720mW/cm, pulse repetition frequency 100Hz, duty cycle 50%, duration 30s with 30s spacing between sonications, 6 sonications per dose (participants receive 0, 1, 2 or 3 doses depending on group assignment)
Interventions
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Low-Intensity Focused Ultrasound Pulsation (LIFUP)
Low intensity focused ultrasound pulsation will be administered to the left entorhinal cortex at 650kHz, ispta.3 720mW/cm, pulse repetition frequency 100Hz, duty cycle 50%, duration 30s with 30s spacing between sonications, 6 sonications per dose (participants receive 0, 1, 2 or 3 doses depending on group assignment)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 50-90
* English-speaking
* Ability to provide informed consent
* Normal or corrected-to-normal hearing and vision
Exclusion Criteria
* Participation in another clinical trial
* Active use of immunotherapeutic medications for cognition (Aduhelm, Leqembi, Kisunla)
* Moderate to Severe Alzheimer's
* Inability to provide informed consent
MRI-Related:
* Weight exceeding 275 pounds
* Pregnancy, suspicion of pregnancy, or attempting to become pregnant
* Claustrophobia
* Difficulties during previous MRIs
* Top permanent retainer (bottom only is okay), 5 or more non-removable gold-teeth, metal braces, top spacers, and/or palate expanders
* Any of the following implants: Cardiac Pacemaker, Aneurysm clips, Cochlear implants, Defibrillator, Electrodes or wires, Magnetically-activated device, Spinal cord stimulator, Infusion or insulin pumps, Implanted drug infusion device, Deep brain stimulation device
* Non-removable hairpieces, hairpiece extensions, and/or piercings
* Facial tattoos or permanent makeup
* Metal implants that are MR-incompatible, or where participant is unable to provide sufficient information to determine MR compatibility
* Previous injury by metallic foreign body (e.g., bullet, BB, shrapnel) where the object entered the body and participant lacks doctor's confirmation that it was fully removed
Medical:
* Diagnosis of one or more of the following neurological disorders: Parkinson's disease, Lou Gehrig's disease (ALS), Multiple sclerosis, Cerebral Palsy
* Diagnosis of one or more of the following genetic disorders: Cystic Fibrosis, Sickle Cell Disease
* Diagnosis of one or more of the following psychiatric disorders: Bipolar, Psychosis
* Psychiatric illness that has not been controlled for at least two months (if controlled \>2 months, with or without medication, they are not exclusionary)
* Severe lung, liver, heart, and/or kidney disease/s (e.g., heart failure, liver failure, and etc...)
* Diagnosis of thyroid disorder or change of thyroid medication dose within the last 3 months
* Cancer treatment/s with chemotherapy and/or radiation to head and neck, or stage 4 (metastatic) cancer
* Autoimmune disorder or viral infection such as HIV, COVID 19, or hepatitis C that has caused current problems with cognition/memory
* History of substance abuse in the past year
* History of stroke (Transient ischemic attack / mini-stroke not exclusionary if symptoms lasted \<1 week)
* History of 2 or more seizures or diagnosis of epilepsy, unless the seizures occurred prior to age 5 alongside a fever.
* History of brain tumor, brain aneurysm, brain hemorrhage, or subdural hematoma (transient ischemic attack not exclusionary)
* Head injury that resulted in loss of consciousness lasting \>30 minutes, cognitive issues lasting \>18 months, and/or brain abnormalities visible in CT or MRI scan
* Uncontrolled high blood pressure or diabetes
* Heart attack within the last year
50 Years
90 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of California, Los Angeles
OTHER
Responsible Party
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Taylor Kuhn
Principal Investigator
Principal Investigators
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Susan Y Bookheimer, PhD
Role: PRINCIPAL_INVESTIGATOR
UCLA Psychiatry & Biobehavioral Sciences
Taylor P Kuhn, PhD
Role: PRINCIPAL_INVESTIGATOR
UCLA Psychiatry & Biobehavioral Sciences
Locations
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UCLA Semel Institute for Neuroscience and Behavior
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Taylor P Kuhn, PhD
Role: backup
Susan Y Bookheimer, PhD
Role: backup
References
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Hescham S, Lim LW, Jahanshahi A, Blokland A, Temel Y. Deep brain stimulation in dementia-related disorders. Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2666-75. doi: 10.1016/j.neubiorev.2013.09.002. Epub 2013 Sep 20.
Lin WT, Chen RC, Lu WW, Liu SH, Yang FY. Protective effects of low-intensity pulsed ultrasound on aluminum-induced cerebral damage in Alzheimer's disease rat model. Sci Rep. 2015 Apr 15;5:9671. doi: 10.1038/srep09671.
Burgess A, Dubey S, Yeung S, Hough O, Eterman N, Aubert I, Hynynen K. Alzheimer disease in a mouse model: MR imaging-guided focused ultrasound targeted to the hippocampus opens the blood-brain barrier and improves pathologic abnormalities and behavior. Radiology. 2014 Dec;273(3):736-45. doi: 10.1148/radiol.14140245. Epub 2014 Sep 15.
Bystritsky A, Korb AS, Douglas PK, Cohen MS, Melega WP, Mulgaonkar AP, DeSalles A, Min BK, Yoo SS. A review of low-intensity focused ultrasound pulsation. Brain Stimul. 2011 Jul;4(3):125-36. doi: 10.1016/j.brs.2011.03.007. Epub 2011 Apr 1.
Related Links
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Study Website
Other Identifiers
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IRB#21-000995
Identifier Type: OTHER
Identifier Source: secondary_id
IRB#21-000995
Identifier Type: -
Identifier Source: org_study_id
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