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Modulation of Hippocampal Circuitry and Memory Function With Focused Ultrasound in Amnestic MCI

About

Brief Summary

This study is a proof of concept/proof of mechanism study addressing the hypothesis that Low Intensity Focused Ultrasound Pulsation (LIFUP) targeting the entorhinal cortex can

(A) successfully target and increase activity in the entorhinal cortex and functionally connected brain regions (B) improve connectivity of memory networks (C) improve memory for information (D) have a dose-dependent effect on memory and brain activity. A secondary objective is to determine the relationship between blood-based AD biomarkers and LIFUP treatment outcomes, and the relationship between magnitude of HC volume decline and LIFUP treatment outcomes.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
50 Years
Maximum Age
90 Years

Inclusion Criteria

  • Amnestic MCI diagnosis
  • Age 50-90
  • English-speaking
  • Right-handed
  • Ability to provide informed consent via UBACC (Jeste et.al., 2007) procedure
  • Normal or corrected-to-normal hearing or vision

Exclusion Criteria

GENERAL Participation in another clinical trial Active use of prescribed medications to improve cognition and/or memory, e.g., cholinesterase inhibitors, memantine, or Aduhelm MRI Incompatibility 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: 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 Cardiac pacemaker 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 (one of the following conditions): The metallic foreign body wasn't fully removed Participant lacks a doctor's confirmation that the metallic foreign body was fully removed Diagnosis of one or more of the following neurological disorders: Alzheimer's disease 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 Psychosis Dementia Mental illness other than anxiety or depression GAD and depression if they have not been controlled for at least one year (if controlled >1 year, with or without medication, they are not exclusionary) Other Medical 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 year Cancer treatment/s with chemotherapy and/or radiation to head and neck Stage 4 (metastatic) cancer Treatment/s for: Hepatitis HIV Rheumatoid arthritis Lupus Any autoimmune disorder Treatment/s to prevent transplant rejection History of substance abuse Including alcohol, but not nicotine or caffeine History of stroke 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) History of concussion or similar head injury if any of the following were present: Head injury requiring hospitalization Head injury succeeded by loss of consciousness for more than 30 minutes Head injury succeeded by amnesia, confusion, and/or loss of orientation lasting longer than 24 hours CT scan that revealed brain abnormalities 2 or more of the following symptoms if they lasted for longer than 3 months after head injury Headache Dizziness Hypersomnia or insomnia Phono- or photophobia Trouble with attention, memory, or staying on task Decline in school performance Depression and/or anxiety Panic attacks PTSD Uncontrolled high blood pressure or diabetes Heart attack within the last year Daily use of prescribed migraine medication

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Study Stats
Protocol No.
21-000995
Category
Semel Institute (Psychiatry)
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05417555
For detailed technical eligibility, visit ClinicalTrials.gov.