Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Last updated: March 20, 2025
Sponsor: Ali Rezai
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

low intensity focused ultrasound (LIFU)

Clinical Study ID

NCT05997030
RNI_NMD_AD01
  • Ages 45-85
  • All Genders

Study 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 Criteria

Inclusion

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 astable dose for at least 45 days

  • Able to communicate sensations during the LIFU procedure

Exclusion

Exclusion Criteria:

  • Unable to undergo MR-imaging because of implanted pacemakers, medication pumps,aneurysm clips, metallic prostheses (including metal pins and rods, heart valves orcochlear implants), shrapnel fragments, permanent make-up or small metal fragmentsin the eye that welders and other metal workers may have, or if candidates areuncomfortable in small spaces (have claustrophobia).

  • Participants with more than 30% of the skull area traversed by the sonicationpathway 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., severeemphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascularcross-sectional area.

  • Participant does not speak English

  • Participant is pregnant or planning to be pregnant

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: low intensity focused ultrasound (LIFU)
Phase:
Study Start date:
October 12, 2023
Estimated Completion Date:
September 30, 2026

Study Description

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

Connect with a study center

  • Rockefeller Neuroscience Institute at West Virginia University

    Morgantown, West Virginia 26505
    United States

    Active - Recruiting

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