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Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Recruiting

Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Who can join

Ages 45 to 85 · All sexes

Full eligibility criteria
Inclusion Criteria:

* Males and non-pregnant females, aged 45-85 years
* Able and willing to give informed consent
* Must meet the clinical criteria for MCI due to Alzheimer's disease
* If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days
* Able to communicate sensations during the LIFU procedure

Exclusion Criteria:

* Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
* Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
* Participants with a history of seizure disorder.
* Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
* Participant does not speak English
* Participant is pregnant or planning to be pregnant

About the study

This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.

What is being tested

Sponsor: Ali Rezai · Participants: 15 · Started: Oct 12, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05997030

Locations in the U.S.

West VirginiaRockefeller Neuroscience Institute at West Virginia University, Morgantown

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.