Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Description

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.

Conditions

Alzheimer Disease

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Study Overview

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Study Details

Study overview

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.

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

Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Morgantown

Rockefeller Neuroscience Institute at West Virginia University, Morgantown, West Virginia, United States, 26505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

45 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ali Rezai,

Ali Rezai, PRINCIPAL_INVESTIGATOR, WVU Rockefeller Neuroscience Institute

Study Record Dates

2025-09-30