Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05997030

Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rockefeller Neuroscience Institute at West Virginia University

Morgantown, West Virginia, 26505, United States

Location status: Recruiting

Location contact

Marc W Haut, PhD

CONTACT

[email protected]

304-293-6276

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Intensity Focused Ultrasound (LIFU)

Device

Subjects will undergo undergo a single LIFU of the target brain region

Primary outcomes

  1. Occurrence of Treatment Emergent Adverse Events

    Time frame: baseline and 7 and days after study procedure

    Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.

  2. Cognitive Change

    Time frame: baseline and 7 days after procedure

    Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

Secondary outcomes

  1. Imaging Changes

    Time frame: baseline, 7 and 30 days

    Changes in brain metabolism and connectivity using PET and fMRI

Study contacts

Contact information is provided by the study sponsor or research team.

Marc Haut, PhD

CONTACT

[email protected]

3042936276

Sponsors and collaborators

Lead sponsor

Ali Rezai

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.