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NCT05997030NARecruiting

Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Ali Rezai

Start Date

10/12/2023

Completion Date

9/30/2026

Summary

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.

Detailed Description

The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for MCI due to AD

Eligibility Criteria

Age Range: 45 years to 85 years

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

Interventions

DEVICE

low intensity focused ultrasound (LIFU)

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Conditions

Alzheimer Disease

Locations

Rockefeller Neuroscience Institute at West Virginia University

Morgantown, West Virginia 26505

United States