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Low-Intensity Focused Ultrasound (LIFU) Neuromodulation
RECRUITINGN/ASponsored by Ali Rezai
Actively Recruiting
PhaseN/A
SponsorAli Rezai
Started2023-10-12
Est. completion2026-09-30
Eligibility
Age45 Years – 85 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05997030
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.
Eligibility
Age: 45 Years – 85 YearsHealthy volunteers accepted
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
Conditions2
Alzheimer DiseaseAlzheimer's Disease
Locations1 site
Rockefeller Neuroscience Institute at West Virginia University
Morgantown, West Virginia, 26505
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Actively Recruiting
PhaseN/A
SponsorAli Rezai
Started2023-10-12
Est. completion2026-09-30
Eligibility
Age45 Years – 85 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05997030